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

NCT ID: NCT04453202

Last Updated: 2025-05-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

459 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-16

Study Completion Date

2021-04-09

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1 Group 1: RSV Vaccine

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

Group Type EXPERIMENTAL

RSV Vaccine

Intervention Type BIOLOGICAL

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

Cohort 1 Group 2: RSV Vaccine

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

Group Type EXPERIMENTAL

RSV Vaccine

Intervention Type BIOLOGICAL

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

Cohort 1 Group 3: RSV Vaccine

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

Group Type EXPERIMENTAL

RSV Vaccine

Intervention Type BIOLOGICAL

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

Cohort 1 Group 4: RSV Vaccine

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

Group Type EXPERIMENTAL

RSV Vaccine

Intervention Type BIOLOGICAL

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

Cohort 1 Group 5: Placebo

Participants will receive IM injection of placebo on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Cohort 2 Group 6: RSV Vaccine

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

Group Type EXPERIMENTAL

RSV Vaccine

Intervention Type BIOLOGICAL

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

Cohort 2 Group 7: RSV Vaccine

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

Group Type EXPERIMENTAL

RSV Vaccine

Intervention Type BIOLOGICAL

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

Cohort 2 Group 8: Placebo

Participants will receive IM injection of placebo on Day 1.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Cohort 3 Group 9: RSV Vaccine

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

Group Type EXPERIMENTAL

RSV Vaccine

Intervention Type BIOLOGICAL

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

Cohort 3 Group 10: RSV Vaccine

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

Group Type EXPERIMENTAL

RSV Vaccine

Intervention Type BIOLOGICAL

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

Cohort 3 Group 11: Placebo

Participants will receive IM injection of placebo on Day 1.

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

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

Interventions

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RSV Vaccine

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

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Optimal Research

San Diego, California, United States

Site Status

Clinical Research of South Florida, an AMR Company

Coral Gables, Florida, United States

Site Status

Heartland Research Associates, an AMR Company

El Dorado, Kansas, United States

Site Status

Optimal Research

Rockville, Maryland, United States

Site Status

The Center for Pharmaceutical Research (CPR)

Kansas City, Missouri, United States

Site Status

Meridian Clinical Research, LLC

Norfolk, Nebraska, United States

Site Status

Meridian Clinical Research - Omaha

Omaha, Nebraska, United States

Site Status

Tekton Research Inc.

Yukon, Oklahoma, United States

Site Status

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

Knoxville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39276619 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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VAC18193RSV2005

Identifier Type: OTHER

Identifier Source: secondary_id

CR108835

Identifier Type: -

Identifier Source: org_study_id

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