Phase 2
Completed N=454
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Healthy
Source: ClinicalTrials.gov NCT04453202 ↗
Enrolled (actual)
454
Serious AEs
2.2%
Results posted
Oct 2023
Primary outcomePrimary: Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination — 4907; 4681; 4038; 5238 EU/L
Summary
The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination |
4907; 4681; 4038; 5238; 272 | — |
| PRIMARY Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 |
37; 42; 3; 23; 37; 2 | — |
| PRIMARY Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 |
39; 43; 8; 19; 41; 7 | — |
| PRIMARY Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 |
13; 8; 7; 3; 8; 2 | — |
| SECONDARY Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1 |
2550; 2790; 1940; 2997; 315; 1568 | — |
| SECONDARY Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 |
6314; 5140; 4725; 6194; 294; 3760 | — |
| SECONDARY Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides |
547; 458; 397; 404; NA; 180 | — |
| SECONDARY Cohort 1: Number of Participants With Serious Adverse Events (SAEs) |
3; 0; 0; 1; 0 | — |
| SECONDARY Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 |
33; 24; 15; 18; 0 | — |
| SECONDARY Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1 |
35; 25; 13; 15; 6 | — |
| SECONDARY Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1 |
11; 9; 6; 5; 1 | — |
| SECONDARY Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1 |
3769; 3893; 259; 4278; 3856; 298 | — |
| SECONDARY Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1 |
4102; 3552; 336; 4085; 3707; 342 | — |
| SECONDARY Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1 |
361; 435; NA; 236; 204; NA | — |
| SECONDARY Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs) |
1; 1; 1; 0; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- In the investigator's clinical judgment, participants 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 signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
- A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
- Agree to not donate blood from the time of vaccination until 3 months after vaccination
- Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
- Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study
Exclusion Criteria
- Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
- 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)
- History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
- Has hepatitis B or C infection, including history of treated hepatitis C infection
- Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization
Data sourced from ClinicalTrials.gov (NCT04453202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.