Respiratory Syncytial Virus (RSV)Phase 1NCT02298179

A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults

A Phase 1 study testing RSV F subunit 45 μg No adjuvant, RSV F subunit 45 μg Aluminum hydroxide adjuvant and RSV F subunit 45 μg MF59 adjuvant in people with Respiratory Syncytial Virus (RSV), run by GlaxoSmithKline at 1 site in Belgium.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus (RSV)
What is being tested?: RSV F subunit 45 μg No adjuvant, RSV F subunit 45 μg Aluminum hydroxide adjuvant and RSV F subunit 45 μg MF59 adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 288 participants
Where: 1 siteBelgium
Study dates: 19 Dec 2014to 27 Mar 2017
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and non-pregnant females 18 to 45 years of age at time of enrollment.
Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
Individuals in good health as determined by the outcome of the medical history, physical examination and clinical judgment of the investigator.
Individuals who can comply with the study procedures and are available for follow up.

Who cannot join

Individuals with any severe chronic or acute disease.
Individuals with a history of illness or with an ongoing illness that may pose additional risk to the subject if he/she participates in the study, including the following:
History of any chronic respiratory illness, including current diagnosis of asthma within 2 years, exercise induced wheezing, reactive airway disease, emphysema, chronic bronchitis, cystic fibrosis or chronic obstructive pulmonary disease (COPD).
Any respiratory illness within 7 days prior to receiving the first study injection.
Any active pulmonary infection or other inflammatory conditions, even in the absence of febrile episodes, within 14 days prior to the first study injection.
Hepatitis B or hepatitis C infection.

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Individuals who have had a malignancy or lymphoproliferative disorder within the past 5 years.
Individuals with known or suspected impairment of the immune system including but not limited to HIV, autoimmune disorders, immunosuppressive therapy, and diabetes mellitus.
Individuals with any history of progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome.
Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Individuals with a BMI > 35 kg/m2. BMI is to be calculated by the following formula: subject weight at baseline divided by subject height in meters multiplied by the subject height in meters. The numerical result will be rounded to the nearest 0.1.
Individuals who are allergic to any of the vaccine components, or with a history of anaphylaxis after vaccination.
Individuals who during the 90 days prior to enrollment receive any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity.
Individuals who receive systemic immunosuppressive agents including steroids. Prior corticosteroid therapy should be discontinued 28 days prior to enrollment. Individuals using inhaled or topical corticosteroids will be permitted.
Receipt or donation of blood or blood products 8 weeks prior to vaccination or planned receipt or donation during the study period.
Individuals participating in any clinical trial with another investigational product 28 days prior to receiving the first study vaccination or intent to participate in another clinical study at any time during the conduct of this study.
Individuals who have received any vaccine 28 days prior to enrollment in this study, or who plan to receive any non-study vaccines within 28 days of the second dose of study vaccine.
Individuals with any clinically significant abnormal safety laboratory result, as judged by the investigator.
If female, 'of childbearing potential', sexually active and has not used any of the 'acceptable contraceptive methods' for at least two months prior to study entry.
Childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least two years; sterile status after bilateral tubal ligation for at least one year, immediately after bilateral oophorectomy or after hysterectomy.
Acceptable methods of birth control are defined as one or more of the following:
Hormonal contraceptives.
Barrier each and every time during intercourse.
Intrauterine device (IUD).
Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to subject's study entry.
If female subject of childbearing potential and have a positive urine pregnancy test prior to study vaccinations, or are currently lactating.
If female of childbearing potential and sexually active, refusal to use an 'acceptable contraceptive method' through to three weeks after last study vaccination.
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Individuals with a history of drug or alcohol abuse within the past 2 years.
Individuals who are acting as study personnel or immediate family members or the spouse of study personnel.
Individuals with a body temperature ≥38 °C (≥100.4◦F) within 3 days of intended study vaccination.
Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Ghent, 9000

Other trials in Belgium

About this study

Official title: A Phase 1 Randomized, Observer Blind, Placebo Controlled, Dosage-Escalation Single Center Study to Evaluate the Safety and Immunogenicity of an RSV Fusion Glycoprotein (F) Subunit Vaccine in Healthy Adults

The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM). In this current Phase 1, first-in-human study, the three different antigen amounts that have been selected will be evaluated in a stepwise manner in three different cohorts (Cohort 1: low dosage of RSV F subunit vaccine, Cohort 2: middle dosage of RSV F subunit vaccine, and Cohort 3: high dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels.

Conditions: Respiratory Syncytial Virus (RSV)
Being tested: RSV F subunit 45 μg No adjuvant, RSV F subunit 45 μg Aluminum hydroxide adjuvant, RSV F subunit 45 μg MF59 adjuvant, RSV F subunit 90 μg No adjuvant, RSV F subunit 90 μg Aluminum hydroxide adjuvant
Keywords: Antibodies, Respiratory syncytial virus, Safety, Healthy adults, Immunogenicity

What participants receive

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

RSV F subunit 45 μg No adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F subunit 45 μg Aluminum hydroxide adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F subunit 45 μg MF59 adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F subunit 90 μg No adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F subunit 90 μg Aluminum hydroxide adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F subunit 90 μg MF59 adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F subunit 135 μg No adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F subunit 135 μg Aluminum hydroxide adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
RSV F subunit 135 μg MF59 adjuvantBiological
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
PlaceboDrug
Also called Sterile saline 0.9%
2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.

Study groups in NCT02298179
Study group	Role	What they receive
RSV F 45 No Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant. Receives: Biological: RSV F subunit 45 μg No adjuvant
RSV F 45 Alum Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant. Receives: Biological: RSV F subunit 45 μg Aluminum hydroxide adjuvant
RSV F 45 MF59 Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant. Receives: Biological: RSV F subunit 45 μg MF59 adjuvant
Placebo 1 Group	Placebo comparator	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1. Receives: Drug: Placebo
RSV F 90 No Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant. Receives: Biological: RSV F subunit 90 μg No adjuvant
RSV F 90 Alum Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant. Receives: Biological: RSV F subunit 90 μg Aluminum hydroxide adjuvant
RSV F 90 MF59 Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant. Receives: Biological: RSV F subunit 90 μg MF59 adjuvant
Placebo 2 Group	Placebo comparator	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2. Receives: Drug: Placebo
RSV F 135 No Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant. Receives: Biological: RSV F subunit 135 μg No adjuvant
RSV F 135 Alum Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant. Receives: Biological: RSV F subunit 135 μg Aluminum hydroxide adjuvant
RSV F 135 MF59 Adj Group	Experimental	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant. Receives: Biological: RSV F subunit 135 μg MF59 adjuvant
Placebo 3 Group	Placebo comparator	Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3. Receives: Drug: Placebo

What is being measured

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

Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Immunogenicity was measured in terms of the Geometric mean titers (GMTs) of the serum anti-RSV neutralizing antibody (NAb) titers at Day 57 (28 days after the second dose).
Measured: At Day 57
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers, from Day 1 (baseline) to Day 57 (28 days after the second dose).
Measured: At Day 57
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Measured: Within 30 minutes after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Measured: From Day 1 (6 hour) through Day 3 after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Measured: From Day 4 through Day 7 after each vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Measured: From Day 1 (6 hours) to Day 7 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Measured: Within 30 minutes after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Measured: From Day 1 (6 hours) through Day 3 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Measured: From Day 4 through Day 7 after each vaccination
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Measured: From Day 1 (6 hours) to Day 7 after each vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: From Day 1 to Day 28 after each vaccination
Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, congenital anomaly or birth defect. Any SAE = occurrence of the SAE regardless of intensity grade. Possibly or probably related SAE = SAE assessed by the investigator as possibly or probably related to the study vaccination.
Other significant AE(s) assessed include unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, new onset of chronic diseases (NOCDs) and adverse events of special interest (AESIs). Medically attended AE = an adverse event that leads to an unscheduled visit to a healthcare practitioner. NOCD = an adverse event that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment.
Measured: From study start (Day 1) until study completion (Day 394)

Secondary outcomes (7)

Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Immunogenicity was measured in terms of GMTs of the serum anti-RSV neutralizing antibody (NAb) titers at Day 1, Day 29 (28 days after the first dose) and Day 181 (six months after the first dose).
Measured: At Day 1, Day 29 and Day 181
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers from Day 1 to Day 29 (28 days after the first dose) and from Day 1 to Day 181 (six months after the first dose).
Measured: At Day 29 and at Day 181
Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1
Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose) with serum anti-RSV NAb titers greater than the 3rd quartile of serum anti-RSV NAb titers at Day 1 (baseline).
Measured: At Day 29, Day 57 and Day 181
Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Immunogenicity was measured in terms of the geometric mean titers (GMTs) of the serum total binding antibody to each of the RSV proteins F, G and N at Day 1 (baseline), Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose).
Measured: At Day 1, Day 29, Day 57 and Day 181
Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Immunogenicity was measured in terms of the percentage of subjects with a ≥ 4-fold increase in serum total binding antibody to each of the RSV Proteins F, G and N from Day 1 (baseline) to all time points (Day 29 [28 days after the first dose], Day 57 [28 days after the second dose], and Day 181 [six months after the first dose]).
Measured: At Day 29, Day 57 and Day 181
Percentage of Subjects With Serum Total Binding Antibody Titers to Each of the RSV Proteins F, G, and N Greater Than the 3rd Quartile of Serum Total Binding Antibody Titers to RSV Protein F at Day 1
Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose), with serum total binding antibody titers to each of the RSV proteins F, G, and N greater than the 3rd quartile of serum total binding antibody titers to RSV protein F at Day 1 (baseline).
Measured: At Day 29, Day 57 and Day 181
Ratio of RSV F Serum Nab Titers to Each of the RSV F Serum Total Binding Antibody Titers to RSV Proteins F, G and N
Immunogenicity was measured in terms of the ratio of RSV F serum Nab titers to each of the RSV F serum total binding antibody titers to RSV proteins F, G and N at Days 1, 29, 57 and 181.
Measured: At Day 1, Day 29, Day 57 and Day 181

Timeline

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

19 Dec 201427 Mar 2017

First posted21 Nov 2014 (estimated)
Study start19 Dec 2014
Primary completion27 Mar 2017
Study completion27 Mar 2017

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 Respiratory Syncytial Virus (RSV)Studies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02298179
Sponsor's protocol ID: 205219
Other IDs: 2014-000145-69, V122_01, 2014
Status last verified: Aug 2018
First submitted: 19 Nov 2014
Last updated: 13 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Schneikart G, Tavarini S, Sammicheli C, Torricelli G, Guidotti S, Andreano E, Buricchi F, D'Oro U, Finco O, Bardelli M. The respiratory syncytial virus fusion protein-specific B cell receptor repertoire reshaped by post-fusion subunit vaccination. Vaccine. 2020 Nov 25;38(50):7916-7927. doi: 10.1016/j.vaccine.2020.10.062. Epub 2020 Oct 29.
PubMed 33131932
Leroux-Roels G, De Boever F, Maes C, Nguyen TL, Baker S, Gonzalez Lopez A. Safety and immunogenicity of a respiratory syncytial virus fusion glycoprotein F subunit vaccine in healthy adults: Results of a phase 1, randomized, observer-blind, controlled, dosage-escalation study. Vaccine. 2019 May 6;37(20):2694-2703. doi: 10.1016/j.vaccine.2019.04.011. Epub 2019 Apr 12.
PubMed 30987852

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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Randomized, Observer Blind, Placebo Controlled, Dosage-Escalation Single Center Study to Evaluate the Safety and Immunogenicity of an RSV Fusion Glycoprotein (F) Subunit Vaccine in Healthy Adults
ClinicalTrials.gov ID: NCT02298179
Acronym / sponsor ID: 205219
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: Antibodies, Respiratory syncytial virus, Safety, Healthy adults, Immunogenicity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Dec 2014 (actual)
Primary completion: 27 Mar 2017 (actual)
Study completion: 27 Mar 2017 (actual)
First posted: 21 Nov 2014 (estimated)
Results: Posted 13 Aug 2018

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
RSV F 45 No Adj Group	Experimental	Biological: RSV F subunit 45 μg No adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with no adjuvant.
RSV F 45 Alum Adj Group	Experimental	Biological: RSV F subunit 45 μg Aluminum hydroxide adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with aluminum hydroxide adjuvant.
RSV F 45 MF59 Adj Group	Experimental	Biological: RSV F subunit 45 μg MF59 adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine [45 μg], with MF59 adjuvant.
Placebo 1 Group	Placebo comparator	Drug: PlaceboHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 1.
RSV F 90 No Adj Group	Experimental	Biological: RSV F subunit 90 μg No adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with no adjuvant.
RSV F 90 Alum Adj Group	Experimental	Biological: RSV F subunit 90 μg Aluminum hydroxide adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with aluminum hydroxide adjuvant.
RSV F 90 MF59 Adj Group	Experimental	Biological: RSV F subunit 90 μg MF59 adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine [90 μg], with MF59 adjuvant.
Placebo 2 Group	Placebo comparator	Drug: PlaceboHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 2.
RSV F 135 No Adj Group	Experimental	Biological: RSV F subunit 135 μg No adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with no adjuvant.
RSV F 135 Alum Adj Group	Experimental	Biological: RSV F subunit 135 μg Aluminum hydroxide adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with aluminum hydroxide adjuvant.
RSV F 135 MF59 Adj Group	Experimental	Biological: RSV F subunit 135 μg MF59 adjuvantHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine [135 μg], with MF59 adjuvant.
Placebo 3 Group	Placebo comparator	Drug: PlaceboHealthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine [45 μg], Cohort 2: middle dosage of RSV F subunit vaccine [90 μg], and Cohort 3: high dosage of RSV F subunit vaccine [135 μg]). This placebo group belongs to Cohort 3.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males and non-pregnant females 18 to 45 years of age at time of enrollment.
Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
Individuals in good health as determined by the outcome of the medical history, physical examination and clinical judgment of the investigator.
Individuals who can comply with the study procedures and are available for follow up.

Key exclusion criteria (32 listed)

Individuals with any severe chronic or acute disease.
Individuals with a history of illness or with an ongoing illness that may pose additional risk to the subject if he/she participates in the study, including the following:
Individuals who have had a malignancy or lymphoproliferative disorder within the past 5 years.
Individuals with known or suspected impairment of the immune system including but not limited to HIV, autoimmune disorders, immunosuppressive therapy, and diabetes mellitus.
Individuals with any history of progressive or severe neurologic disorder, seizure disorder or Guillian-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
RSV F subunit 45 μg No adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 45 No Adj Group
RSV F subunit 45 μg Aluminum hydroxide adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 45 Alum Adj Group
RSV F subunit 45 μg MF59 adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 45 MF59 Adj Group
RSV F subunit 90 μg No adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 90 No Adj Group
RSV F subunit 90 μg Aluminum hydroxide adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 90 Alum Adj Group
RSV F subunit 90 μg MF59 adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 90 MF59 Adj Group
RSV F subunit 135 μg No adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 135 No Adj Group
RSV F subunit 135 μg Aluminum hydroxide adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 135 Alum Adj Group
RSV F subunit 135 μg MF59 adjuvant2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Biological	RSV F 135 MF59 Adj Group
PlaceboAlso: Sterile saline 0.9%2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.	Drug	Placebo 1 Group, Placebo 2 Group, Placebo 3 Group

Primary outcome

Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Time frame: At Day 57
Immunogenicity was measured in terms of the Geometric mean titers (GMTs) of the serum anti-RSV neutralizing antibody (NAb) titers at Day 57 (28 days after the second dose).
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers
Time frame: At Day 57
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers, from Day 1 (baseline) to Day 57 (28 days after the second dose).
Number of Subjects With Any Solicited Local Symptoms
Time frame: Within 30 minutes after each vaccination
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Local Symptoms
Time frame: From Day 1 (6 hour) through Day 3 after each vaccination
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Local Symptoms
Time frame: From Day 4 through Day 7 after each vaccination
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Local Symptoms
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Time frame: Within 30 minutes after each vaccination
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Time frame: From Day 1 (6 hours) through Day 3 after each vaccination
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Time frame: From Day 4 through Day 7 after each vaccination
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: From Day 1 to Day 28 after each vaccination
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s)
Time frame: From study start (Day 1) until study completion (Day 394)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, congenital anomaly or birth defect. Any SAE = occurrence of the SAE regardless of intensity grade. Possibly or probably related SAE = SAE assessed by the investigator as possibly or probably related to the study vaccination. Other significant AE(s) assessed include unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, new onset of chronic diseases (NOCDs) and adverse events of special interest (AESIs). Medically attended AE = an adverse event that leads to an unscheduled visit to a healthcare practitioner. NOCD = an adverse event that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment.

7 secondary outcomes

Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers
Time frame: At Day 1, Day 29 and Day 181
Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer
Time frame: At Day 29 and at Day 181
Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1
Time frame: At Day 29, Day 57 and Day 181
Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Time frame: At Day 1, Day 29, Day 57 and Day 181
Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N
Time frame: At Day 29, Day 57 and Day 181
Percentage of Subjects With Serum Total Binding Antibody Titers to Each of the RSV Proteins F, G, and N Greater Than the 3rd Quartile of Serum Total Binding Antibody Titers to RSV Protein F at Day 1
Time frame: At Day 29, Day 57 and Day 181
Ratio of RSV F Serum Nab Titers to Each of the RSV F Serum Total Binding Antibody Titers to RSV Proteins F, G and N
Time frame: At Day 1, Day 29, Day 57 and Day 181

Results and safety

Results posted to the registry on 13 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RSV F 45 No Adj Group	24	24
RSV F 45 Alum Adj Group	24	24
RSV F 45 MF59 Adj Group	24	23
Placebo 1 Group	24	24
RSV F 90 No Adj Group	24	24
RSV F 90 Alum Adj Group	24	24
RSV F 90 MF59 Adj Group	24	24
Placebo 2 Group	24	23
RSV F 135 No Adj Group	24	24
RSV F 135 Alum Adj Group	24	24
RSV F 135 MF59 Adj Group	24	24
Placebo 3 Group	24	24

Primary outcome: Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers

Time frame: At Day 57. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	RSV F 45 No Adj Group n = 22	RSV F 45 Alum Adj Group n = 24	RSV F 45 MF59 Adj Group n = 22	Placebo 1 Group n = 23	RSV F 90 No Adj Group n = 24	RSV F 90 Alum Adj Group n = 24	RSV F 90 MF59 Adj Group n = 22	Placebo 2 Group n = 23	RSV F 135 No Adj Group n = 23	RSV F 135 Alum Adj Group n = 22	RSV F 135 MF59 Adj Group n = 24	Placebo 3 Group n = 24
Value	864 (692 to 1077)	914 (738 to 1134)	843 (673 to 1057)	234 (169 to 324)	844 (665 to 1072)	746 (587 to 947)	944 (735 to 1213)	253 (189 to 337)	903 (729 to 1119)	1212 (974 to 1509)	1316 (1066 to 1623)	254 (183 to 354)

Population analysed: The analysis was based on the Per-Protocol Set (PPS), which included all subjects in the Full Analysis Set (FAS) Immunogenicity population who were not excluded due to the reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 57.

Primary outcome: Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers

Time frame: At Day 57. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	RSV F 45 No Adj Group n = 22	RSV F 45 Alum Adj Group n = 24	RSV F 45 MF59 Adj Group n = 22	Placebo 1 Group n = 23	RSV F 90 No Adj Group n = 24	RSV F 90 Alum Adj Group n = 24	RSV F 90 MF59 Adj Group n = 22	Placebo 2 Group n = 23	RSV F 135 No Adj Group n = 23	RSV F 135 Alum Adj Group n = 22	RSV F 135 MF59 Adj Group n = 24	Placebo 3 Group n = 24
Value	45 (24.4 to 67.8)	54 (32.8 to 74.4)	36 (17.2 to 59.3)	0 (0.0 to 14.8)	25 (9.8 to 46.7)	29 (12.6 to 51.1)	41 (20.7 to 63.6)	0 (0.0 to 14.8)	17 (5.0 to 38.8)	45 (24.4 to 67.8)	46 (25.6 to 67.2)	0 (0.0 to 14.2)

Population analysed: The analysis was based on PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and and for whom immunogenicity results collected from Day 1 (baseline) up to Day 57 were available at Day 1 and Day 57.

Primary outcome: Number of Subjects With Any Solicited Local Symptoms

Time frame: Within 30 minutes after each vaccination. Count of participants. Unit: Participants

Measure	RSV F 45 No Adj Group n = 24	RSV F 45 Alum Adj Group n = 24	RSV F 45 MF59 Adj Group n = 24	Placebo 1 Group n = 24	RSV F 90 No Adj Group n = 24	RSV F 90 Alum Adj Group n = 24	RSV F 90 MF59 Adj Group n = 24	Placebo 2 Group n = 24	RSV F 135 No Adj Group n = 24	RSV F 135 Alum Adj Group n = 24	RSV F 135 MF59 Adj Group n = 24	Placebo 3 Group n = 24
Any Induration (1st)	0	0	0	0	0	0	0	0	0	0	0	0
Any Swelling (1st)	0	0	0	0	0	0	0	0	0	0	0	0
Any Erythema (1st)	0	0	0	0	0	0	0	0	0	0	0	0
Any Pain (1st)	3	1	0	3	1	4	4	2	2	2	1	3
Any Induration (2nd)	0	0	0	0	0	0	0	0	0	0	0	0
Any Swelling (2nd)	0	0	0	0	0	0	0	0	0	0	0	0
Any Erythema (2nd)	0

Primary outcome: Number of Subjects With Any Solicited Local Symptoms

Time frame: From Day 1 (6 hour) through Day 3 after each vaccination. Count of participants. Unit: Participants

Measure	RSV F 45 No Adj Group n = 24	RSV F 45 Alum Adj Group n = 24	RSV F 45 MF59 Adj Group n = 24	Placebo 1 Group n = 24	RSV F 90 No Adj Group n = 24	RSV F 90 Alum Adj Group n = 24	RSV F 90 MF59 Adj Group n = 24	Placebo 2 Group n = 24	RSV F 135 No Adj Group n = 24	RSV F 135 Alum Adj Group n = 24	RSV F 135 MF59 Adj Group n = 24	Placebo 3 Group n = 24
Any Induration (1st)	0	3	2	0	1	2	3	0	0	2	2	1
Any Swelling (1st)	0	0	1	0	0	0	2	0	2	0	1	0
Any Erythema (1st)	1	0	0	0	1	1	2	0	0	1	0	0
Any Pain (1st)	12	21	19	2	10	18	20	2	12	22	18	5
Any Induration (2nd)	0	0	1	0	1	1	0	0	2	0	1	1
Any Swelling (2nd)	0	0	1	0	0	0	0	0	2	1	0	0
Any Erythema (2nd)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and systemic symptoms: from Day 1 (6 hours) through Day 7 after each vaccination; Unsolicited AEs: from Day 1 through Day 28 after each vaccination; SAEs: from study start (Day 1) to study completion (Day 394).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RSV F 45 No Adj Group	1 of 24 (4.2%)	23 of 24 (95.8%)	0 of 24
RSV F 45 Alum Adj Group	1 of 24 (4.2%)	24 of 24 (100%)	0 of 24
RSV F 45 MF59 Adj Group	1 of 24 (4.2%)	24 of 24 (100%)	0 of 24
Placebo 1 Group	0 of 24 (0%)	23 of 24 (95.8%)	0 of 24
RSV F 90 No Adj Group	1 of 24 (4.2%)	24 of 24 (100%)	0 of 24
RSV F 90 Alum Adj Group	0 of 24 (0%)	24 of 24 (100%)	0 of 24
RSV F 90 MF59 Adj Group	4 of 24 (16.7%)	24 of 24 (100%)	0 of 24
Placebo 2 Group	0 of 24 (0%)	21 of 24 (87.5%)	0 of 24
RSV F 135 No Adj Group	1 of 24 (4.2%)	23 of 24 (95.8%)	0 of 24
RSV F 135 Alum Adj Group	2 of 24 (8.3%)	24 of 24 (100%)	0 of 24
RSV F 135 MF59 Adj Group	0 of 24 (0%)	23 of 24 (95.8%)	0 of 24
Placebo 3 Group	0 of 24 (0%)	22 of 24 (91.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33131932Schneikart G, Tavarini S, Sammicheli C, Torricelli G, Guidotti S, Andreano E, Buricchi F, D'Oro U, Finco O, Bardelli M. The respiratory syncytial virus fusion protein-specific B cell receptor repertoire reshaped by post-fusion subunit vaccination. Vaccine. 2020 Nov 25;38(50):7916-7927. doi: 10.1016/j.vaccine.2020.10.062. Epub 2020 Oct 29.
Derived from this study: PubMed 30987852Leroux-Roels G, De Boever F, Maes C, Nguyen TL, Baker S, Gonzalez Lopez A. Safety and immunogenicity of a respiratory syncytial virus fusion glycoprotein F subunit vaccine in healthy adults: Results of a phase 1, randomized, observer-blind, controlled, dosage-escalation study. Vaccine. 2019 May 6;37(20):2694-2703. doi: 10.1016/j.vaccine.2019.04.011. Epub 2019 Apr 12.

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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

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 32 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 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 13 Aug 2018). 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?

Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers (time frame: At Day 57). 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 NCT02298179, 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 13 Aug 2018.