NCT03502707

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

A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations 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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 669 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-07-06
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2018-04-19
• Last updated: 2025-05-25
• Results posted: 2023-09-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study