NCT03502707

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
669

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 6, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 13, 2023

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

3.9 years

First QC Date

April 11, 2018

Results QC Date

August 14, 2023

Last Update Submit

May 22, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (21)

  • Cohort 1: Number of Participants With Serious Adverse Events (SAEs)

    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)

    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)

    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)

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (12)

  • Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints

    Days 1, 15, 29, 57, 85, 183, 365, 393, and 547

  • Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints

    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

    Day 29

  • Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85

    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

    Days 1, 15, 29, 57, 85, 183, 365, 393, and 547

  • +7 more secondary outcomes

Study Arms (21)

Cohort (C)1 Group (G)1: Placebo for RSV preF Protein

PLACEBO COMPARATOR

Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.

Biological: Placebo

C1 G2: RSV preF Protein

EXPERIMENTAL

Participants will receive intramuscular injection of 50 microgram (mcg) RSV preF protein on Day 1, Day 57 and at Month 12.

Biological: RSV preF Protein 50 mcg

C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein

PLACEBO COMPARATOR

Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.

Biological: Placebo

C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein

EXPERIMENTAL

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.

Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg

C1 G5: RSV preF Protein

EXPERIMENTAL

Participants will receive intramuscular injection of 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.

Biological: RSV preF Protein 150 mcg

C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein

PLACEBO COMPARATOR

Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.

Biological: Placebo

C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein

EXPERIMENTAL

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.

Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg

C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein

PLACEBO COMPARATOR

Participants will receive intramuscular injection of placebo on Day 1 and at Month 12 and in only 1 arm on Day 57.

Biological: Placebo

C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg

C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: RSV preF Protein 150 mcgBiological: Ad26.RSV.preF 1*10^11 vp

C2 G11: Ad26.RSV.preF and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: Ad26.RSV.preF 1*10^11 vp

C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg

C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg

C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg

C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg

C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: RSV preF Protein 150 mcgBiological: Ad26.RSV.preF 1*10^11 vp

C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo

EXPERIMENTAL

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.

Biological: PlaceboBiological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg

C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein

PLACEBO COMPARATOR

Participants will receive intramuscular injection of placebo in separate arms on Day 1 and in only 1 arm on Day 57.

Biological: Placebo

C3 G19: Selected Regimen (SR)

EXPERIMENTAL

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.

Biological: Selected Regimen

C3 G20: SR + Placebo for SR

EXPERIMENTAL

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.

Biological: PlaceboBiological: Selected Regimen

C3 G21: Placebo for SR

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

PlaceboBIOLOGICAL

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.

C1 G10: Ad26.RSV.preF, RSV preF Protein and PlaceboC1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF ProteinC1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF ProteinC1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF ProteinC1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and PlaceboC2 G11: Ad26.RSV.preF and PlaceboC2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and PlaceboC2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and PlaceboC2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and PlaceboC2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and PlaceboC2 G16: Ad26.RSV.preF, RSV preF Protein and PlaceboC2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and PlaceboC2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF ProteinC3 G20: SR + Placebo for SRC3 G21: Placebo for SRCohort (C)1 Group (G)1: Placebo for RSV preF Protein
RSV preF Protein 50 mcgBIOLOGICAL

RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.

Also known as: JNJ-64213175
C1 G2: RSV preF Protein
RSV preF Protein 150 mcgBIOLOGICAL

RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.

Also known as: JNJ-64213175
C1 G10: Ad26.RSV.preF, RSV preF Protein and PlaceboC1 G5: RSV preF ProteinC2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Ad26.RSV.preF 1*10^11 vpBIOLOGICAL

Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1\*10\^11 vp.

Also known as: JNJ-64400141
C1 G10: Ad26.RSV.preF, RSV preF Protein and PlaceboC2 G11: Ad26.RSV.preF and PlaceboC2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcgBIOLOGICAL

Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.

C1 G4: Mixture of Ad26.RSV.preF/RSV preF ProteinC2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcgBIOLOGICAL

Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.

C1 G7: Mixture of Ad26.RSV.preF/RSV preF ProteinC2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcgBIOLOGICAL

Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.

C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcgBIOLOGICAL

Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.

C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and PlaceboC2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and PlaceboC2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Selected RegimenBIOLOGICAL

A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.

C3 G19: Selected Regimen (SR)C3 G20: SR + Placebo for SR

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Optimal Research

Huntsville, Alabama, 35802, United States

Location

Optimal Research

San Diego, California, 92108, United States

Location

Optimal Research

Melbourne, Florida, 32934, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Optimal Research

Rockville, Maryland, 20850, United States

Location

Optimal Research

Austin, Texas, 78705, United States

Location

Related Publications (1)

  • Comeaux CA, Bart S, Bastian AR, Klyashtornyy V, De Paepe E, Omoruyi E, van der Fits L, van Heesbeen R, Heijnen E, Callendret B, Sadoff J. Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. J Infect Dis. 2024 Jan 12;229(1):19-29. doi: 10.1093/infdis/jiad220.

    PMID: 37433021DERIVED

Results Point of Contact

Title
Clinical Franchise Leader
Organization
Janssen Vaccines & Prevention B.V.
ClinicalTrialDisclosure@its.jnj.com
844-434-4210

Study Officials

  • Janssen Vaccines & Prevention B.V. Clinical Trial

    Janssen Vaccines & Prevention B.V.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 19, 2018

Study Start

July 6, 2018

Primary Completion

May 16, 2022

Study Completion

May 16, 2022

Last Updated

May 25, 2025

Results First Posted

September 13, 2023

Record last verified: 2025-05

Locations

US(6)