Lyme BorreliosisPhase 2NCT03970733

Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis

A Phase 2 study testing VLA15 in people with Lyme Borreliosis, run by Pfizer at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Lyme Borreliosis
What is being tested?: VLA15
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 246 participants
Where: 5 sitesUnited States
Study dates: 1 Jul 2019to 28 Mar 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is aged 18 to 65 years at the day of screening
Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
Subject has an understanding of the study and its procedures, agrees to its provisions,and gives written informed consent prior to any study-related procedures;
If subject is of childbearing potential:
Subject has a negative serum pregnancy test at screening;
Subject agrees to employ adequate birth control measures for the duration of the study.

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Randomization into higher dose group in the Main Study Phase
No relevant protocol deviation in the Main Study Phase, i.e., included in the Per-Protocol population for the Day 208 interim analysis of the Main Study;
Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
If subject is of childbearing potential:
Subject has a negative Urine pregnancy test before booster vaccination;
Subject agrees to employ adequate birth control measures for the duration of the study

Who cannot join

Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to screening;
Subject received previous vaccination against LB.;
Subject had a tick bite within 4 weeks prior to vaccination visit;
Subject has a medical history of or currently has a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible;
Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the three weeks prior to each study vaccination, contraindicating I.M. vaccination as judged by the investigator;

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Subject has received an active or passive immunization within 28 days before or after any vaccination; except for influenza (seasonal or pandemic) vaccines which may be administered outside a 7-days interval before or after any trial vaccination;
Subject has received any other non-registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and throughout the entire study period or has received a registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and up to Day 208;
Subject has a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), Status post organ transplantation or immuno-suppressive therapy within 30 days prior to first vaccination. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent >=0.05 mg/kg/day. Topical and inhaled steroids are allowed;
Subject has a history of anaphylaxis or severe allergic reactions or a known hypersensitivity or allergic reactions to one of the components of the vaccine; Subject had any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled;
Subject had acute febrile infections within 10 days prior to first vaccination;
Subject is pregnant (positive serum pregnancy test at screening), has plans to become pregnant during the course of the study or is lactating at the time of enrollment. Women of childbearing potential that are unwilling or unable to employ an adequate birth Control measure for the duration of the study.
Subject has donated blood or blood-derived products (e.g. plasma) within 30 days or received blood or blood-derived products (e.g. plasma) within 90 days prior to first vaccination in this study or plans to donate or use blood or blood products during the course of the study;
Subject has any condition that, in the opinion of the investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would Limit the subject's ability to complete the study;
Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
Subject is in a dependent relationship with the sponsor, an investigator or other study team member, or the study center. Dependent relationships include close relatives and household members (i.e. children, partner/spouse, siblings, parents) as well as employees of the investigator or study center personnel.
Subject met an individual stopping criterion during the Main Study Phase;
Subject has developed a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to vaccination visit;
Subject has developed a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for further participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment;
Subject has developed a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
Subject has developed an immunodeficiency, including known infection with human immunodeficiency virus (HIV), status post organ transplantation, or immuno-suppressive therapy within 30 days prior to vaccination visit. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent >= 0.05 mg/kg/day. Topical and inhaled steroids are allowed;
Subject has developed anaphylaxis or severe allergic reactions;
Subject has developed allergic reactions to one of the components of the vaccine;
Subject has developed a malignancy;
Subject has developed thrombocytopenia or received anticoagulants in the 3 weeks prior to the booster vaccination contraindicating I.M. vaccination as judged by the investigator;
Subject has received any other non-registered medicinal product in another clinical trial within 28 days prior to VLA15 booster vaccination at Month 18 or plans to participate in another clinical trial with a non-registered medicinal product until Month 24;
Subject is pregnant, or plans to become pregnant prior to Month 24, or is lactating. Women of childbearing potential that are unwilling or unable to employ an adequate birth control measure for the duration of the study;
Subject has developed any condition that, in the opinion of the investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
Subject has been committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
Subject is in a dependent relationship with the sponsor, an investigator or other study team member, or the study center. Dependent relationships include close relatives and household members (i.e. children, partner/spouse, sibling).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

United Medical Associates
Binghamton, New York, 13901
Regional Clinical Research, Inc
Endwell, New York, 13760
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905

Other trials in United States

About this study

Official title: ALTERNATIVE SCHEDULE STUDY FOR VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.

In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18.

Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.

Study duration per subject in the Booster Phase is a maximum of approximately 13 months.

Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.

Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.

Read the detailed description

This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study.

In Main Study Phase a total of 246 healthy subjects,aged 18 to 65 years, were randomized 2:2:1 to receive either VLA15 with Alum (lower or higher doser Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1 (Month 0), Day 57 (Month 2) and Day 180 (Month 6).

Subjects from the higher dose group who completed their primary immunization schedule according to protocol, will be randomized 2:1 to receive an additional injection of the higher dose VLA15 with Alum or Placebo in a Booster Phase. The additional vaccination is administered as intramuscular injection approximately 18 months after the first immunization.

Conditions: Lyme Borreliosis
Being tested: VLA15, Placebo
Keywords: VLA15, Lyme Borreliosis, Vaccine
Medical subject headings: Lyme Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VLA15Biological
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
PlaceboBiological
PBS (Phosphate Buffered Saline)

Study groups in NCT03970733
Study group	Role	What they receive
VLA15 with Alum lower dose	Experimental	Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued Receives: Biological: VLA15
VLA15 with Alum higher dose	Experimental	Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo Receives: Biological: VLA15
Placebo	Placebo comparator	Main Study Phase: placebo - Booster Phase: arm discontinued Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

GMTs for IgG Against Each OspA Serotype
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)
Measured: Day 208 (Month 7)

Secondary outcomes (34)

GMTs for IgG Against Each OspA Serotype During the Main Study Phase
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 365 (Month 12) and 545 (Month 18).
Measured: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 365 (Month 12) and Day 545 (Month 18)
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
Seroconversion Rate (SCR) for each Outer Surface Protein A (OspA) serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18). Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations.
Measured: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
Geometric Mean Fold Rise (GMFR) as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18).
Measured: Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years.
Measured: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years.
Measured: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): >=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants.
Measured: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): >=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants.
Measured: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years.
Measured: Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years.
Measured: Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Related SAEs During the Main Study Phase
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Related AESIs During the Main Study Phase
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Unsolicited AEs During the Main Study Phase
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Related Unsolicited AEs During the Main Study Phase
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: Up to 7 days after Vaccination 1, 2 and 3; Up to 7 days after any vaccination
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during main study phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day 1 of vaccination up to Day 545 (Month 18)
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Measured: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Measured: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
GMFR as compared to baseline for IgG against each Osp serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 were reported in this outcome measure. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Measured: Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
GMFR as compared to Day 208 for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 208 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Measured: Day 208 (from where comparison was done), Month 19, Month 24 and Month 30
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
GMFR as compared to Month 18 (pre-booster) for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population.
Measured: Month 18 (from where comparison was done), Month 19, Month 24 and Month 30
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Measured: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 50 - 65 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Measured: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years was presented in this outcome measure. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): >=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Measured: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30 stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): >=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Measured: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Percentage of Participants With SAEs During the Entire Booster Phase
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Percentage of Participants With Related SAEs During the Entire Booster Phase
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Percentage of Participants With Related AESIs During the Entire Booster Phase
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19
An unsolicited AE includes any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)
Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19
An unsolicited AE included any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination
Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method.
Measured: Within 7 days after booster vaccination
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during booster phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine; Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up.
Measured: SAEs and AESIs: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months); AEs: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201928 Mar 2022

First posted31 May 2019
Study start1 Jul 2019
Primary completion7 Apr 2020
Study completion28 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lyme BorreliosisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03970733
Sponsor's protocol ID: VLA15-202
Other IDs: C4601007
Status last verified: Mar 2023
First submitted: 29 May 2019
Last updated: 21 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Ghadge SK, Schneider M, Dubischar K, Wagner L, Kadlecek V, Obersriebnig M, Hochreiter R, Klingler A, Larcher-Senn J, Derhaschnig U, Bender W, Eder-Lingelbach S, Bezay N. Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in healthy adults in the USA: results of the booster phase of a randomised, controlled, phase 2 trial. Lancet Infect Dis. 2024 Nov;24(11):1275-1286. doi: 10.1016/S1473-3099(24)00372-4. Epub 2024 Jul 16.
PubMed 39029481
Bezay N, Wagner L, Kadlecek V, Obersriebnig M, Wressnigg N, Hochreiter R, Schneider M, Dubischar K, Derhaschnig U, Klingler A, Larcher-Senn J, Eder-Lingelbach S, Bender W. Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies. Lancet Infect Dis. 2024 Sep;24(9):1045-1058. doi: 10.1016/S1473-3099(24)00175-0. Epub 2024 May 31.
PubMed 38830375

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Lyme Disease
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Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Lyme Disease
Recruiting
Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.
Lyme Borreliosis, Physical Activity
Not yet recruitingObservational study
The Precision Mito- Mito Map COMPASS Study
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome

All Lyme Borreliosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ALTERNATIVE SCHEDULE STUDY FOR VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS, IN HEALTHY ADULTS AGED 18 TO 65 YEARS - A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY.
ClinicalTrials.gov ID: NCT03970733
Acronym / sponsor ID: VLA15-202
Conditions: Lyme Borreliosis
Keywords: VLA15, Lyme Borreliosis, Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Valneva Austria GmbH
Study start: 1 Jul 2019 (actual)
Primary completion: 7 Apr 2020 (actual)
Study completion: 28 Mar 2022 (actual)
First posted: 31 May 2019 (actual)
Results: Posted 8 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.

Study duration per subject in the Booster Phase is a maximum of approximately 13 months.

Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.

Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.

Detailed description

This is a randomized, observer-blind (subject, Sponsor and investigator/site staff involved in Clinical Evaluation of subjects are blinded), Placebo controlled, multicenter Phase 2 study.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
VLA15 with Alum lower dose	Experimental	Biological: VLA15Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued
VLA15 with Alum higher dose	Experimental	Biological: VLA15Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo
Placebo	Placebo comparator	Biological: PlaceboMain Study Phase: placebo - Booster Phase: arm discontinued

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subject is aged 18 to 65 years at the day of screening
Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
Subject has an understanding of the study and its procedures, agrees to its provisions,and gives written informed consent prior to any study-related procedures;
If subject is of childbearing potential:
Subject has a negative serum pregnancy test at screening;

Key exclusion criteria (30 listed)

Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to screening;
Subject received previous vaccination against LB.;
Subject had a tick bite within 4 weeks prior to vaccination visit;
Subject has a medical history of or currently has a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible;
Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VLA15a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate	Biological	VLA15 with Alum higher dose, VLA15 with Alum lower dose
PlaceboPBS (Phosphate Buffered Saline)	Biological	Placebo

Primary outcome

GMTs for IgG Against Each OspA Serotype
Time frame: Day 208 (Month 7)
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)

34 secondary outcomes

GMTs for IgG Against Each OspA Serotype During the Main Study Phase
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 365 (Month 12) and Day 545 (Month 18)
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
Time frame: Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
Time frame: Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
Time frame: Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)
Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Related SAEs During the Main Study Phase
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Related AESIs During the Main Study Phase
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Unsolicited AEs During the Main Study Phase
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Related Unsolicited AEs During the Main Study Phase
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Time frame: Up to 7 days after Vaccination 1, 2 and 3; Up to 7 days after any vaccination
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
Time frame: From Day 1 of vaccination up to Day 545 (Month 18)
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
Time frame: Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
Time frame: Day 208 (from where comparison was done), Month 19, Month 24 and Month 30
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
Time frame: Month 18 (from where comparison was done), Month 19, Month 24 and Month 30
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
Time frame: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
Time frame: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30
Percentage of Participants With SAEs During the Entire Booster Phase
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Percentage of Participants With Related SAEs During the Entire Booster Phase
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Percentage of Participants With Related AESIs During the Entire Booster Phase
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)
Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)
Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19
Time frame: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination
Time frame: Within 7 days after booster vaccination
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
Time frame: SAEs and AESIs: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months); AEs: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)

Results and safety

Results posted to the registry on 8 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VLA15 With Alum Lower Dose	97	89
VLA15 With Alum Higher Dose	98	84
Placebo	51	46
Booster Phase: VLA15 With Alum Higher Dose	0	0
Booster Phase: Placebo	0	0

Primary outcome: GMTs for IgG Against Each OspA Serotype

Time frame: Day 208 (Month 7). Geometric mean (95% Confidence Interval). Unit: Units per milliliter (U/mL)

Measure	VLA15 With Alum Lower Dose n = 78	VLA15 With Alum Higher Dose n = 80	Placebo n = 38
ST1 Day 208	278.5 (214.9 to 361.0)	274.7 (209.4 to 360.4)	21.0 (19.6 to 22.5)
ST2 Day 208	545.2 (431.8 to 688.4)	579.8 (461.9 to 727.8)	20.0 (20.0 to 20.0)
ST3 Day 208	520.0 (410.5 to 658.7)	596.8 (471.9 to 754.8)	20.0 (20.0 to 20.0)
ST4 Day 208	332.6 (261.3 to 423.3)	367.8 (293.8 to 460.4)	21.3 (19.8 to 23.0)
ST5 Day 208	332.8 (262.9 to 421.3)	358.8 (283.7 to 453.7)	20.0 (20.0 to 20.0)
ST6 Day 208	339.9 (267.3 to 432.3)	345.7 (273.7 to 436.6)	21.4 (19.4 to 23.5)

Population analysed: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

34 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Study Phase: VLA15 With Alum Lower Dose	4 of 97 (4.1%)	94 of 97 (96.9%)	0 of 97
Main Study Phase: VLA15 With Alum Higher Dose	4 of 98 (4.1%)	97 of 98 (99%)	0 of 98
Main Study Phase: Placebo	2 of 51 (3.9%)	40 of 51 (78.4%)	0 of 51
Booster Phase: VLA15 With Alum Higher Dose	3 of 39 (7.7%)	35 of 39 (89.7%)	0 of 39
Booster Phase: Placebo	0 of 19 (0%)	11 of 19 (57.9%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39029481Ghadge SK, Schneider M, Dubischar K, Wagner L, Kadlecek V, Obersriebnig M, Hochreiter R, Klingler A, Larcher-Senn J, Derhaschnig U, Bender W, Eder-Lingelbach S, Bezay N. Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in healthy adults in the USA: results of the booster phase of a randomised, controlled, phase 2 trial. Lancet Infect Dis. 2024 Nov;24(11):1275-1286. doi: 10.1016/S1473-3099(24)00372-4. Epub 2024 Jul 16.
Derived from this study: PubMed 38830375Bezay N, Wagner L, Kadlecek V, Obersriebnig M, Wressnigg N, Hochreiter R, Schneider M, Dubischar K, Derhaschnig U, Klingler A, Larcher-Senn J, Eder-Lingelbach S, Bender W. Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies. Lancet Infect Dis. 2024 Sep;24(9):1045-1058. doi: 10.1016/S1473-3099(24)00175-0. Epub 2024 May 31.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VLA15 in people with Lyme Borreliosis, run by Pfizer at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GMTs for IgG Against Each OspA Serotype (time frame: Day 208 (Month 7)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03970733, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.