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Ad26.RSV.preF 5*10^10 vp

Phase 1

Healthy | Monoclonal antibody | Other |Johnson & Johnson|Last Updated: Feb 19, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment73
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02926430A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable HealthPHASE1 COMPLETED 73 — — Nov 8, 2016Jan 29, 2019Feb 19, 20191 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
7 days after each vaccination (Day 1)
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
7 days after each vaccination (Day 365)
Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1)
7 days after each vaccination (Day 1)
Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365)
7 days after each vaccination (Day 365)
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive)
Number of Participants With Serious Adverse Events (SAEs) Throughout Study
Up to 730 days
Secondary Endpoints
Respiratory Syncytial Virus (RSV) Neutralization A2
Days 1, 29, 183, 365, 393, 547, 730
RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay
Days 1, 29, 183, 365, 393, 547, 730
Intracellular Cytokine Staining
Day 1, 29, 183, 365, 393, 547, 730
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1EXPERIMENTALParticipants will receive 5\*10\^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2EXPERIMENTALParticipants will receive 5\*10\^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3EXPERIMENTALParticipants will receive 1\*10\^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4EXPERIMENTALParticipants will receive 1\*10\^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
Placebo (Day 1 and Day 365): Group 5EXPERIMENTALParticipants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination).
Interventions
NameTypeDescription
Ad26.RSV.preF 5*10^10 vpBIOLOGICALAd26.RSV.preF will be given at a concentration of 5\*10\^10 vp/0.5 milliliter (mL).
Ad26.RSV.preF 1*10^11 vpBIOLOGICALAd26.RSV.preF will be given at a concentration of 1\*10\^11 vp/0.5 milliliter (mL).
PlaceboDRUGParticipants will receive placebo as formulation buffer.
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study proced...

Countries:United States
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