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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

Ad26.RSV.preF 5*10^10 vp · 1 trial · 1 indication

Phase 1 1
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 HealthHealthy
COMPLETED73 Analytics
PHASE1COMPLETED
A 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 Health
Healthy
NCT0292643073
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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 to 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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Frequently asked questions about Ad26.RSV.preF 5*10^10 vp

What is Ad26.RSV.preF 5*10^10 vp used for?

Ad26.RSV.preF 5*10^10 vp is an investigational vaccine being studied for use in healthy adults aged 60 years and older. It is designed to evaluate safety, tolerability, and immunogenicity when given as two vaccinations one year apart. The vaccine is currently in Phase 1 clinical development.

Who makes Ad26.RSV.preF 5*10^10 vp?

Ad26.RSV.preF 5*10^10 vp is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the vaccine's safety and immune response in older adults.

What phase is Ad26.RSV.preF 5*10^10 vp in?

Ad26.RSV.preF 5*10^10 vp is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under study for its intended use in healthy older adults.

What clinical trials is Ad26.RSV.preF 5*10^10 vp in?

Ad26.RSV.preF 5*10^10 vp has been studied in one completed Phase 1 trial with the identifier NCT02926430. This trial evaluated the safety, tolerability, and immunogenicity of two vaccinations given one year apart in adults aged 60 years and older in stable health. The study enrolled 73 participants in the United States.

Is Ad26.RSV.preF 5*10^10 vp the same as Ad26.RSV.preF?

Ad26.RSV.preF 5*10^10 vp is a specific dose formulation of the Ad26.RSV.preF vaccine candidate. The dose is indicated in the name as 5 times 10 to the 10th power viral particles. This formulation was tested in the Phase 1 clinical trial for safety and immunogenicity.