A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

NCT04453202 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CR108835VAC18193RSV2005
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

  Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.

  14 days after vaccination on Day 1 (Day 15)

• Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1

  Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was 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 pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.

  Until 7 days after Vaccination on Day 1 (Day 8)

• Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1

  Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree celsius).

  Until 7 days after Vaccination on Day 1 (Day 8)

• Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1

  Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was 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 included chills, injection site erythema, injection site pruritus Et cetera (etc).

  Until 28 days after Vaccination on Day 1 (Day 29)

Secondary Outcomes (11)

• Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1

  At 3 and 6 months after vaccination on Day 1

• Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1

  At 14 days and 3 and 6 months after vaccination on Day 1

• Cohort 1: 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

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

  Baseline (Day1) up to 6 months

• Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1

  Until 7 days after vaccination on Day 1 (Day 8)

Study Arms (11)

Cohort 1 Group 1: RSV Vaccine

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.

Biological: RSV Vaccine

Cohort 1 Group 2: RSV Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.

Biological: RSV Vaccine

Cohort 1 Group 3: RSV Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.

Biological: RSV Vaccine

Cohort 1 Group 4: RSV Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.

Biological: RSV Vaccine

Cohort 1 Group 5: Placebo

PLACEBO COMPARATOR

Participants will receive IM injection of placebo on Day 1.

Other: Placebo

Cohort 2 Group 6: RSV Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Biological: RSV Vaccine

Cohort 2 Group 7: RSV Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.

Biological: RSV Vaccine

Cohort 2 Group 8: Placebo

PLACEBO COMPARATOR

Participants will receive IM injection of placebo on Day 1.

Other: Placebo

Cohort 3 Group 9: RSV Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Biological: RSV Vaccine

Cohort 3 Group 10: RSV Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.

Biological: RSV Vaccine

Cohort 3 Group 11: Placebo

EXPERIMENTAL

Participants will receive IM injection of placebo on Day 1.

Other: Placebo

Interventions

RSV Vaccine BIOLOGICAL

Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.

Cohort 1 Group 1: RSV Vaccine; Cohort 1 Group 2: RSV Vaccine; Cohort 1 Group 3: RSV Vaccine; Cohort 1 Group 4: RSV Vaccine; Cohort 2 Group 6: RSV Vaccine; Cohort 2 Group 7: RSV Vaccine; Cohort 3 Group 10: RSV Vaccine; Cohort 3 Group 9: RSV Vaccine

Placebo OTHER

Participants will receive a single IM injection of placebo on Day 1.

Cohort 1 Group 5: Placebo; Cohort 2 Group 8: Placebo; Cohort 3 Group 11: Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (9)

Optimal Research

San Diego, California, 92108, United States

Location

Clinical Research of South Florida, an AMR Company

Coral Gables, Florida, 33134, United States

Location

Heartland Research Associates, an AMR Company

El Dorado, Kansas, 67042, United States

Location

Optimal Research

Rockville, Maryland, 20850, United States

Location

The Center for Pharmaceutical Research (CPR)

Kansas City, Missouri, 64114, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research - Omaha

Omaha, Nebraska, 68134, United States

Location

Tekton Research Inc.

Yukon, Oklahoma, 73099, United States

Location

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• van Heesbeen R, Bastian AR, Omoruyi E, Rosen J, Comeaux CA, Callendret B, Heijnen E. Immunogenicity and safety of different dose levels of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 years and older: A randomized, double-blind, placebo-controlled, phase 2a study. Vaccine. 2024 Dec 2;42(26):126273. doi: 10.1016/j.vaccine.2024.126273. Epub 2024 Sep 13.

  PMID: 39276619 DERIVED

MeSH Terms

Interventions

Respiratory Syncytial Virus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 1, 2020
• Study Start: July 16, 2020
• Primary Completion: September 24, 2020
• Study Completion: April 9, 2021
• Last Updated: May 25, 2025
• Results First Posted: October 3, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (9)