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A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older

NCT03502707 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2025-05-25

Study results available
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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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Placebo

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.

BIOLOGICAL

RSV preF Protein 50 mcg

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

BIOLOGICAL

RSV preF Protein 150 mcg

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

BIOLOGICAL

Ad26.RSV.preF 1*10^11 vp

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

Selected Regimen

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

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2022-05-16
Completion
2022-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03502707 on ClinicalTrials.gov