Respiratory Syncytial Virus InfectionsPhase 1NCT03674177
A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
A Phase 1 study testing GSK3888550A RSV Maternal vaccine formulation 1, GSK3888550A RSV Maternal vaccine formulation 2 and GSK3888550A RSV Maternal vaccine formulation 3 in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 11 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data. As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- GSK3888550A RSV Maternal vaccine formulation 1, GSK3888550A RSV Maternal vaccine formulation 2 and GSK3888550A RSV Maternal vaccine formulation 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 30 Oct 2018to 2 Sep 2019
- Phase
- Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
- Written informed consent obtained from the subject;
- Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the vaccination;
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception until 90 days after vaccination
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding vaccination or any planned use during the study period;
- Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
- Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs, as well as administration of long acting immune modifying drugs, within 6 months prior to the vaccine dose (for corticosteroids, this will mean prednisone higher than or equal to (≥) 5 milligrams per day (mg/day), or equivalent). Inhaled and topical steroids are allowed;
- Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination;
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination;
- Previous experimental vaccination against RSV;
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- Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports;
- Family history of congenital or hereditary immunodeficiency;
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- Any acute or chronic, clinically significant disease, as determined by physical examination, laboratory screening tests, subject personal report and/or health care provider information. The following conditions will be exclusionary:
- Diabetes mellitus,
- Respiratory diseases, such as:
- Chronic Pulmonary diseases, including Chronic Obstructive Pulmonary Disease (COPD),
- Bronchopulmonary dysplasia (note: history of past bronchopulmonary dysplasia as a neonate/infant will not be exclusionary),
- Uncontrolled asthma or asthma necessitating treatment with chronic systemic glucocorticoids
- Significant and/or uncontrolled psychiatric illness:
- hospitalization for psychiatric illness, history of suicide attempt(s) or confinement for danger to self or others within 10 years
- clinically significant depression
- Major neurological disease including:
- seizure or adulthood epilepsy (note: history of febrile convulsion in childhood is not exclusionary)
- myasthenia gravis
- history of repetitive migraine mal/status migrainosus
- Significant cardiovascular disease, including:
- Uncontrolled arterial hypertension,
- Congenital heart disease (with the exception of corrected atrial or ventricular septal defects),
- Previous myocardial infarction,
- Valvular heart disease or history of rheumatic fever,
- Previous bacterial endocarditis,
- History of cardiac surgery (with the exception of corrected atrial or ventricular septal defects),
- Personal or family history of cardiomyopathy or sudden adult death.
- Known or suspected Hepatitis B or Hepatitis C infection,
- Any other significant uncontrolled medical illness, defined as any illness requiring new medical and/or surgical treatment or significant modification of treatment dose due to uncontrolled symptoms or drug toxicity, within 3 months prior to study vaccination.
- History of or current autoimmune disease;
- Body mass index (BMI) > 40 Kilograms (kg)/square meters(m^2);
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive precautions;
- Hypersensitivity to latex;
- Lymphoproliferative disorder or malignancy within previous 5 years;
- Acute disease and/or fever at the time of enrolment;
- Fever is defined as temperature ≥ 38°C/100.4°F
- For subjects with acute disease and/or fever at the time of enrolment, Visit 1 will be rescheduled within the allowed window for the visit.
- Subjects with fever at screening may be re-screened 1 time at a later date.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- Any clinically significant or any ≥ Grade 2* haematological (haemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, and platelets) and biochemical (alanine aminotransferase [ALT] aspartate aminotransferase [AST], creatinine, blood urea nitrogen [BUN]) laboratory abnormality detected at the last screening blood sampling; *Grading of laboratory parameters will be based on the FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials".
- For Grade 1 laboratory abnormalities, the investigator should use clinical judgement to decide which ones are clinically relevant.
- Subjects with haematological/biochemical values out of normal range at screening which are expected to be temporary, may be re-screened 1 time at a later date.
- Any other condition that the investigator judges may interfere with study procedures or findings;
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe;
- Alcoholism, drug abuse and/or use disorder within the past two years (as defined in Diagnostic and Statistical Manual of Mental Disorders [DSM-5] Diagnostic Criteria);
- Planned move to a location that will prohibit participating in the trial until study end.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Germany5 sites
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Würzburg, Bavaria, 97070
Finland4 sites
GSK Investigational Site
Helsinki, 00260
GSK Investigational Site
Tampere, FI-33100
GSK Investigational Site
Turku, 20100
GSK Investigational Site
Turku, 20540
United States2 sites
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Rochester, New York, 14609
About this study
Official title: A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational Unadjuvanted RSV Maternal Vaccine Compared to Placebo When Administered to Healthy Non-pregnant Women.
The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data.
As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.
Read the detailed description
Healthy non-pregnant women 18-45 years of age will be randomized in a 1:1:1:1 ratio to receive one of three dose levels (30, 60, 120 micrograms [µg]) of the investigational RSV maternal vaccine (GSK3888550A) or placebo, administered as a single intramuscular injection (IM).
There will be a screening visit and five study visits scheduled at Day 1 (study vaccination), Day 8, Day 31, Day 61, and Day 91 to evaluate the primary and secondary objectives of safety/reactogenicity and immunogenicity profiles of the 3 dose levels. Subjects will also be contacted at Day 181. During this contact, the investigator (or delegate) will ask the subject if she has experienced any serious adverse events (SAEs) and or any adverse events (AEs) leading to study withdrawal since the last study visit (Day 360), as well as if she has become pregnant during the post-vaccination period. The investigator (or delegate) will also ask the subject about concomitant vaccinations/products/medications that she has received since the last study visit (D91). Contact should be performed preferably via telephone. Other means of contact (email/other) may be acceptable provided the required information can be fully collected.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- GSK3888550A RSV Maternal vaccine formulation 1, GSK3888550A RSV Maternal vaccine formulation 2, GSK3888550A RSV Maternal vaccine formulation 3, Placebo (Normal Saline)
- Keywords
- Vaccines, Safety, Immunogenicity, Reactogenicity, Respiratory Syncytial Viruses
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3888550A RSV Maternal vaccine formulation 1Biological
Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
GSK3888550A RSV Maternal vaccine formulation 2Biological
Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
GSK3888550A RSV Maternal vaccine formulation 3Biological
Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
Placebo (Normal Saline)Drug
Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| RSV MAT formulation 1 Group | Experimental | Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Receives: Biological: GSK3888550A RSV Maternal vaccine formulation 1 |
| RSV MAT formulation 2 Group | Experimental | Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Receives: Biological: GSK3888550A RSV Maternal vaccine formulation 2 |
| RSV MAT formulation 3 Group | Experimental | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm Receives: Biological: GSK3888550A RSV Maternal vaccine formulation 3 |
| Control Group | Placebo comparator | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm Receives: Drug: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters.
Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters.
Measured: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever.
Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F).
Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F).
Related fatigue, gastrointestinal symptoms, headache and fever(>38°C) = symptoms assessed by the investigator as related to the vaccination.
Measured: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal 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 for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days)
Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period
Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days)
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8].
Measured: At Day 8
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31].
Measured: At Day 31
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8].
Measured: At Day 8
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31].
Measured: At Day 31
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Measured: At Day 8
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Measured: At Day 31
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Measured: At Day 8
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Measured: At Day 31
Secondary outcomes (3)
Number of Subjects With SAEs
Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Day 1 (vaccination) up to Day 91 and up to Day 181
Neutralizing Antibody (Nab) Titers Against RSV Serotype A
Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60), calculated on subjects with anti-RSV-A neutralizing antibody titer equal to or above the assay cut-off 18 ED60.
Measured: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL), calculated on subjects with anti-RSVPreF3 antibody concentration equal to or above the assay cut-off 25 EL.U/mL.
Measured: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start30 Oct 2018
- Primary completion16 Apr 2019
- Study completion2 Sep 2019
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 (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674177
- Sponsor's protocol ID
- 208068
- Other IDs
- 2018-001340-62, 2018
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2018
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study is available via the Clinical Study Data Request site
Publications
Schwarz TF, Johnson C, Grigat C, Apter D, Csonka P, Lindblad N, Nguyen TL, Gao FF, Qian H, Tullio AN, Dieussaert I, Picciolato M, Henry O. Three Dose Levels of a Maternal Respiratory Syncytial Virus Vaccine Candidate Are Well Tolerated and Immunogenic in a Randomized Trial in Nonpregnant Women. J Infect Dis. 2022 Jun 15;225(12):2067-2076. doi: 10.1093/infdis/jiab317.
PubMed 34146100
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational Unadjuvanted RSV Maternal Vaccine Compared to Placebo When Administered to Healthy Non-pregnant Women.
- ClinicalTrials.gov ID
- NCT03674177
- Acronym / sponsor ID
- 208068
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Vaccines, Safety, Immunogenicity, Reactogenicity, Respiratory Syncytial Viruses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Posted 15 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data.
As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.
Detailed description
Healthy non-pregnant women 18-45 years of age will be randomized in a 1:1:1:1 ratio to receive one of three dose levels (30, 60, 120 micrograms [µg]) of the investigational RSV maternal vaccine (GSK3888550A) or placebo, administered as a single intramuscular injection (IM).
There will be a screening visit and five study visits scheduled at Day 1 (study vaccination), Day 8, Day 31, Day 61, and Day 91 to evaluate the primary and secondary objectives of safety/reactogenicity and immunogenicity profiles of the 3 dose levels. Subjects will also be contacted at Day 181. During this contact, the investigator (or delegate) will ask the subject if she has experienced any serious adverse events (SAEs) and or any adverse events (AEs) leading to study withdrawal since the last study visit (Day 360), as well as if she has become pregnant during the post-vaccination period. The investigator (or delegate) will also ask the subject about concomitant vaccinations/products/medications that she has received since the last study visit (D91). Contact should be performed preferably via telephone. Other means of contact (email/other) may be acceptable provided the required information can be fully collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RSV MAT formulation 1 Group | Experimental | Biological: GSK3888550A RSV Maternal vaccine formulation 1Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| RSV MAT formulation 2 Group | Experimental | Biological: GSK3888550A RSV Maternal vaccine formulation 2Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| RSV MAT formulation 3 Group | Experimental | Biological: GSK3888550A RSV Maternal vaccine formulation 3Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| Control Group | Placebo comparator | Drug: Placebo (Normal Saline)Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
- Written informed consent obtained from the subject;
- Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the vaccination;
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
Key exclusion criteria (51 listed)
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding vaccination or any planned use during the study period;
- Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
- Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs, as well as administration of long acting immune modifying drugs, within 6 months prior to the vaccine dose (for corticosteroids, this will mean prednisone higher than or equal to (≥) 5 milligrams per day (mg/day), or equivalent). Inhaled and topical steroids are allowed;
- Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination;
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination;
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 |
|---|---|---|
| GSK3888550A RSV Maternal vaccine formulation 1Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm | Biological | RSV MAT formulation 1 Group |
| GSK3888550A RSV Maternal vaccine formulation 2Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm | Biological | RSV MAT formulation 2 Group |
| GSK3888550A RSV Maternal vaccine formulation 3Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm | Biological | RSV MAT formulation 3 Group |
| Placebo (Normal Saline)Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm | Drug | Control Group |
Primary outcome
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period
Time frame: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters.
Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period
Time frame: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever. Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F). Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F). Related fatigue, gastrointestinal symptoms, headache and fever(>38°C) = symptoms assessed by the investigator as related to the vaccination.
Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period
Time frame: During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal 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 for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period
Time frame: From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days)
Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Time frame: At Day 8
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8].
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Time frame: At Day 31
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31].
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Time frame: At Day 8
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8].
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Time frame: At Day 31
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31].
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Time frame: At Day 8
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Time frame: At Day 31
Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8
Time frame: At Day 8
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31
Time frame: At Day 31
Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges.
3 secondary outcomes
Number of Subjects With SAEs
Time frame: From Day 1 (vaccination) up to Day 91 and up to Day 181
Neutralizing Antibody (Nab) Titers Against RSV Serotype A
Time frame: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations
Time frame: At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34146100Schwarz TF, Johnson C, Grigat C, Apter D, Csonka P, Lindblad N, Nguyen TL, Gao FF, Qian H, Tullio AN, Dieussaert I, Picciolato M, Henry O. Three Dose Levels of a Maternal Respiratory Syncytial Virus Vaccine Candidate Are Well Tolerated and Immunogenic in a Randomized Trial in Nonpregnant Women. J Infect Dis. 2022 Jun 15;225(12):2067-2076. doi: 10.1093/infdis/jiab317.
- Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request site
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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.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3888550A RSV Maternal vaccine formulation 1, GSK3888550A RSV Maternal vaccine formulation 2 and GSK3888550A RSV Maternal vaccine formulation 3 in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 11 sites in 3 countries.
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 6 inclusion and 51 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 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Finland, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 15 Apr 2020). 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?
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period (time frame: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)). The study lists 12 primary outcomes in all. 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 NCT03674177, which also lists 1 linked publication.
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 13 Aug 2021.