Trial Outcomes & Findings for A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old (NCT NCT05083585)
NCT ID: NCT05083585
Last Updated: 2025-05-25
Results Overview
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV based vaccine were reported.
COMPLETED
PHASE3
250 participants
14 days post vaccination on Day 1 (Day 15)
2025-05-25
Participant Flow
Participant milestones
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
125
|
|
Overall Study
Vaccinated (Full Analysis Set [FAS])
|
123
|
125
|
|
Overall Study
COMPLETED
|
119
|
123
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Randomized but not vaccinated
|
2
|
0
|
Baseline Characteristics
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
Baseline characteristics by cohort
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=123 Participants
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=125 Participants
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 3.85 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 4.34 • n=7 Participants
|
64 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
123 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days post vaccination on Day 1 (Day 15)Population: The per-protocol immunogenicity (PPI) set included all randomized participants who received the study vaccine, and for whom immunogenicity data were available.
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV based vaccine were reported.
Outcome measures
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=114 Participants
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=120 Participants
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
|
5054 ELISA units per liter (EU/L)
Interval 4444.0 to 5748.0
|
4836 ELISA units per liter (EU/L)
Interval 4220.0 to 5543.0
|
SECONDARY outcome
Timeframe: Up to Day 7 post vaccination on Day 1 (up to Day 8)Population: The full analysis set (FAS) included all participants who received study vaccination, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Number of participants with solicited local AEs 7 days post vaccination on Day 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 were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).
Outcome measures
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=121 Participants
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=125 Participants
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination
|
84 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Up to Day 7 post vaccination on Day 1 (up to Day 8)Population: The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Number of participants with solicited systemic AEs 7 days post vaccination on Day 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 systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were 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).
Outcome measures
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=121 Participants
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=125 Participants
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination
|
76 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28 post vaccination on Day 1 (up to Day 29)Population: The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations.
Number of participants with unsolicited AEs 28 days post vaccination on Day 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 were all AEs for which the participant was not specifically questioned in the participant diary.
Outcome measures
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=123 Participants
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=125 Participants
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)Population: The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations.
Number of participants with SAEs until 6 months post vaccination on Day 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. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Outcome measures
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=123 Participants
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=125 Participants
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)Population: The FAS included all participants who received study vaccination, regardless of the occurrence of protocol deviations.
Number of participants with AESIs until 6 months post vaccination on Day 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. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
Outcome measures
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=123 Participants
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=125 Participants
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 days post vaccination on Day 1 (Day 15)Population: The PPI set included all randomized participants who received the study vaccine, and for whom immunogenicity data were available.
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units.
Outcome measures
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=114 Participants
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=120 Participants
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination
|
7710 Titers
Interval 6623.0 to 8976.0
|
7256 Titers
Interval 6231.0 to 8450.0
|
Adverse Events
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
Serious adverse events
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=123 participants at risk
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=125 participants at risk
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/123 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.80%
1/125 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Cardiac disorders
Cardiac Arrest
|
0.81%
1/123 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/125 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/123 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.80%
1/125 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/123 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.80%
1/125 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.81%
1/123 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/125 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
Other adverse events
| Measure |
Group 1 (Phase 3 CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=123 participants at risk
Participants received a single intramuscular (IM) injection of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1.0\*10\^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF) 150 micrograms (mcg) based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 3 clinical trial material (CTM).
|
Group 2 (Phase 2b CTM): Ad26.RSV.preF 1.0*10^11 vp + RSV preF Protein 150 mcg
n=125 participants at risk
Participants received a single IM injection of Ad26.RSV.preF 1.0\*10\^11 vp and RSV preF protein 150 mcg based vaccine mixture (Ad26/protein preF RSV) on Day 1, which was a representative of Phase 2b CTM.
|
|---|---|---|
|
General disorders
Chills
|
2.4%
3/123 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
1.6%
2/125 • From Day 1 until 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations.
|
Additional Information
Director Biomarkers Viral Vaccines
Janssen Vaccines & Prevention B.V.
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER