A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
The purpose of this study for:
Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3.
Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen.
Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
- Biological: Placebo
- Biological: RSV preF Protein 50 mcg
- Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
- Biological: RSV preF Protein 150 mcg
- Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
- Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
- Biological: Ad26.RSV.preF 1*10^11 vp
- Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
- Biological: Selected Regimen
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Alabama
-
Huntsville, Alabama, United States, 35802
- Optimal Research
-
-
California
-
San Diego, California, United States, 92108
- Optimal Research
-
-
Florida
-
Melbourne, Florida, United States, 32934
- Optimal Research
-
-
Illinois
-
Peoria, Illinois, United States, 61614
- Optimal Research
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- Optimal Research
-
-
Texas
-
Austin, Texas, United States, 78705
- Optimal Research
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Before randomization, a woman must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
- In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States (US) Food and Drug Administration (FDA) toxicity, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- From the time of each vaccination through 3 months after each vaccination, participant agrees not to donate blood
- Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
Exclusion Criteria:
- Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
- Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
- Participant has a known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
- Participant has received respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study at any time prior to randomization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Cohort (C)1 Group (G)1: Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
|
|
Experimental: C1 G2: RSV preF Protein
Participants will receive intramuscular injection of 50 microgram (mcg) RSV preF protein on Day 1, Day 57 and at Month 12.
|
RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.
Other Names:
|
|
Placebo Comparator: C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
|
|
Experimental: C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of a mixture of 5*10^10 viral particles (vp) of Ad26.RSV.preF/RSV
preF 50 mcg protein on Day 1, Day 57 and at Month 12.
|
Mixture of Ad26.RSV.preF
(5*10^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
|
|
Experimental: C1 G5: RSV preF Protein
Participants will receive intramuscular injection of 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
|
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
Other Names:
|
|
Placebo Comparator: C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
|
|
Experimental: C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of a mixture of 5*10^10 vp of Ad26.RSV.preF
plus 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
|
Mixture of Ad26.RSV.preF
(5*10^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
|
|
Placebo Comparator: C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1 and at Month 12 and in only 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
|
|
Experimental: C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp of Ad26.RSV.preF
plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and at Month 12 and placebo in another arm on Day 1 and at Month 12.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF
(1*10^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
|
|
Experimental: C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and at Month 12 and placebo in 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
Other Names:
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1*10^11 vp.
Other Names:
|
|
Experimental: C2 G11: Ad26.RSV.preF and Placebo
Participants will receive intramuscular injection of 1*10^11 vp of Ad26.RSV.preF in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1*10^11 vp.
Other Names:
|
|
Experimental: C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 5*10^10 vp Ad26.RSV.preF
plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF
(5*10^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
|
|
Experimental: C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp Ad26.RSV.preF
plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF
(1*10^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
|
|
Experimental: C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp Ad26.RSV.preF
plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF
(1*10^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
|
|
Experimental: C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 5*10^10 vp Ad26.RSV.preF
plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF
(5*10^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
|
|
Experimental: C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Data from C1 G10 will be pooled with those of C2 G16.
Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and placebo in 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
Other Names:
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1*10^11 vp.
Other Names:
|
|
Experimental: C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Data from C1 G9 will be pooled with those of C2 G17.
Participants will receive intramuscular injection of a mixture of 1*10^11 vp of Ad26.RSV.preF
plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and placebo in another arm on Day 1.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Mixture of Ad26.RSV.preF
(1*10^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
|
|
Placebo Comparator: C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo in separate arms on Day 1 and in only 1 arm on Day 57.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
|
|
Experimental: C3 G19: Selected Regimen (SR)
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and a booster (the SR) at Month 12 and month 24.
The participants who are randomized to two-dose regimen will receive SR on Day 1 and Day 57, and a booster (the selected regimen) at Month 12.
|
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
|
|
Experimental: C3 G20: SR + Placebo for SR
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and Month 24, and a placebo at Month 12.
The participants who are randomized to two-dose regimen will receive selected regimen on Day 1 and Day 57, and a placebo at Month 12.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
|
|
Placebo Comparator: C3 G21: Placebo for SR
If a one-dose regimen is selected, participants in this group will receive placebo for SR on Day 1 and at Month 12 and Month 24.
The participants who are randomized to two-dose regimen will receive placebo for SR on Day 1, Day 57, and Month 12.
|
Placebo for Ad26.RSV.preF,
RSV preF protein, Ad26.RSV.preF/RSV
preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From Day 1 up to Day 730
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
The outcome measure was planned to be analyzed for specified arms only.
|
From Day 1 up to Day 730
|
|
Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From Day 1 up to Day 730
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
The outcome measure was planned to be analyzed for specified arms only.
|
From Day 1 up to Day 730
|
|
Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From Day 1 up to Day 1095
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
The outcome measure was planned to be analyzed for specified arms only.
|
From Day 1 up to Day 1095
|
|
Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From Day 1 up to Day 1095
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
The outcome measure was planned to be analyzed for specified arms only.
|
From Day 1 up to Day 1095
|
|
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Time Frame: 7 days post-vaccination 1 on Day 1 (Day 8)
|
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
|
7 days post-vaccination 1 on Day 1 (Day 8)
|
|
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Time Frame: 7 days post-vaccination 2 on Day 57 (Day 64)
|
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
|
7 days post-vaccination 2 on Day 57 (Day 64)
|
|
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Time Frame: 7 days post-vaccination 3 on Day 365 (Day 372)
|
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
|
7 days post-vaccination 3 on Day 365 (Day 372)
|
|
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Time Frame: 7 days post-vaccination 1 on Day 1 (Day 8)
|
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
|
7 days post-vaccination 1 on Day 1 (Day 8)
|
|
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Time Frame: 7 days post-vaccination 2 on Day 57 (Day 64)
|
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
|
7 days post-vaccination 2 on Day 57 (Day 64)
|
|
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Time Frame: 7 days post-vaccination 1 on Day 1 (Day 8)
|
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
|
7 days post-vaccination 1 on Day 1 (Day 8)
|
|
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Time Frame: 7 days post-vaccination 2 on Day 365 (Day 372)
|
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
|
7 days post-vaccination 2 on Day 365 (Day 372)
|
|
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Time Frame: 7 days post-vaccination 3 on Day 730 (Day 737)
|
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).
Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
|
7 days post-vaccination 3 on Day 730 (Day 737)
|
|
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Time Frame: 28 days post-vaccination 1 on Day 1 (Day 29)
|
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
|
28 days post-vaccination 1 on Day 1 (Day 29)
|
|
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Time Frame: 28 days post-vaccination 2 on Day 57 (Day 85)
|
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
|
28 days post-vaccination 2 on Day 57 (Day 85)
|
|
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Time Frame: 28 days post-vaccination 3 on Day 365 (Day 393)
|
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
|
28 days post-vaccination 3 on Day 365 (Day 393)
|
|
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Time Frame: 28 days post-vaccination 1 on Day 1 (Day 29)
|
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
|
28 days post-vaccination 1 on Day 1 (Day 29)
|
|
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Time Frame: 28 days post-vaccination 2 on Day 57 (Day 85)
|
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
|
28 days post-vaccination 2 on Day 57 (Day 85)
|
|
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Time Frame: 28 days post-vaccination 1 on Day 1 (Day 29)
|
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
|
28 days post-vaccination 1 on Day 1 (Day 29)
|
|
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Time Frame: 28 days post-vaccination 2 on Day 365 (Day 393)
|
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
|
28 days post-vaccination 2 on Day 365 (Day 393)
|
|
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Time Frame: 28 days post-vaccination 3 on Day 730 (Day 758)
|
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
|
28 days post-vaccination 3 on Day 730 (Day 758)
|
|
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
Time Frame: Day 29
|
RSV A2 Strain neutralization antibody titers on Day 29 was reported.
Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay.
The outcome measure was planned to be analyzed for specified arms only.
|
Day 29
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
Time Frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
|
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 1 was reported.
The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
|
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
|
|
Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints
Time Frame: Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758
|
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 3 was reported.
The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
|
Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758
|
|
Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29
Time Frame: Day 29
|
RSV A2 strain neutralization antibody titers on Day 29 in Group 16 of Cohort 2 was reported.
The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
The outcome measure was planned to be reported for specified arms only.
|
Day 29
|
|
Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85
Time Frame: Day 85
|
RSV A2 strain neutralization antibody titers on Day 85 in Group 17 of Cohort 2 was reported.
The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
The outcome measure was planned to be reported for specified arms only.
|
Day 85
|
|
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
Time Frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
|
GMT (ELISA units per liter [EU/L]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 1 were reported.
|
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
|
|
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
Time Frame: Days 1, 15, 29, 57, 85, 183, 365, and 547
|
GMT (ELISA units per liter [EU/L]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 2 were reported.
|
Days 1, 15, 29, 57, 85, 183, 365, and 547
|
|
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
Time Frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
|
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 1 were reported.
|
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
|
|
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
Time Frame: Days 1, 15, 29, 57, 85, 183, 365, and 547
|
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 2 were reported.
|
Days 1, 15, 29, 57, 85, 183, 365, and 547
|
|
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Time Frame: Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
|
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 1 were reported.
The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.
The unit was Spot forming units (SFU)/10^6 peripheral blood mononuclear cells (PBMCs).
|
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
|
|
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Time Frame: Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758
|
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 3 were reported.
The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.
The unit was SFU/10^6 PBMCs.
|
Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758
|
|
Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29
Time Frame: Day 29
|
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot Assay on Day 29 in Groups 11-16 of Cohort 2 was reported.
The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.
The outcome measure was planned to be analyzed for specified arms only.
|
Day 29
|
|
Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85
Time Frame: Day 85
|
Breadth of IFN-gamma T-Cells responses analyzed by ELISpot assay on Day 85 in Group 17 of Cohort 2 was reported.
The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.
The outcome measure was planned to be analyzed for specified arms only.
|
Day 85
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- CR108456
- VAC18193RSV1004 (Other Identifier: Janssen Vaccines & Prevention B.V.)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
NCT06818032RecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokers
-
NCT07232121RecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult Male
-
NCT07197047CompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | Stretching
-
NCT05361343RecruitingHealthy Aging | Healthy Diet | Healthy Lifestyle
-
NCT05218980Not yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | Cholesterol
-
NCT07515417Active, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality
-
NCT03278535CompletedHealthy Volunteers | Healthy Subjects | Healthy Adults
-
NCT07520474CompletedHealthy Participants | Healthy Adult Participants | Healthy Young Adults
-
NCT07597928Not yet recruiting
-
NCT07285122RecruitingHealthy | Healthy Smoker
Clinical Trials on Placebo
-
NCT03827590UnknownAcute Bronchitis | Acute Upper Respiratory Tract Infection
-
NCT02177513Completed
-
NCT06767540Not yet recruiting
-
NCT02935712CompletedMale Subjects With Type II Diabetes (T2DM)
-
NCT03198624CompletedPharmacokinetics | Safety Issues
-
NCT02982187CompletedPulmonary Disease, Chronic Obstructive
-
NCT04693039Completed
-
NCT04388215UnknownHypertension | Dyslipidemias
-
NCT01610388Completed