Recent Updates
Recently added Catalysts

MRKAd5 HIV-1 gag vaccine

Phase 1

Hepatitis C | Vaccine | Infectious Disease |Merck & Company, Inc.|Trials Updated: Aug 25, 2015

MRKAd5 HIV-1 gag vaccine target and mechanism

ModalityVaccine

Also known as MRKAd5 HIV-1 gag vaccine (V520)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindSHAM_CONTROLLEDDMC
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

MRKAd5 HIV-1 gag vaccine clinical trials

MRKAd5 HIV-1 gag vaccine · 1 trial · 1 indication

Phase 1 1
NCT00857311MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)Hepatitis C
COMPLETED17 Analytics
PHASE1COMPLETED
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)
up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs

Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable \& unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine.

Secondary Endpoints

Number of Participants With Systemic and Laboratory Adverse Events (AE)
up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs
Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen
Week 30 (4 weeks after boost injection)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MRKAd5 HIV-1 gag vaccine 1x10^9 vp/doseEXPERIMENTALParticipants administered MRKAd5 HIV-1 gag vaccine 1x10\^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 gag vaccine 1x10^10 vp/doseEXPERIMENTALParticipants were to be administered MRKAd5 HIV-1 gag 1x10\^10 vp/dose (V520) on Day 1, Week 4, and Week 26. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10\^10 vp/dose.
PlaceboEXPERIMENTALParticipants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
Open Label Tetanus and Diptheria Toxoids AdsorbedSHAM_COMPARATORParticipants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group.

Interventions

NameTypeDescription
MRKAd5 HIV-1 gag vaccine (V520)BIOLOGICAL3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10\^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26
Comparator: PlaceboBIOLOGICAL1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26
Comparator: Open Label Tetanus and Diptheria Toxoids AdsorbedBIOLOGICAL0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study Exclusion Criteria: * Subject weighs less than 110 lbs. * Subject has received treatment for hepatitis C virus infection in the 3 months before enrollment...

Unlock Eligibility Criteria

Competitive Landscape -Hepatitis C 13 trials

Top 1 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir
Unlock Competitive Intelligence

Frequently asked questions about MRKAd5 HIV-1 gag vaccine

What is MRKAd5 HIV-1 gag vaccine?

MRKAd5 HIV-1 gag vaccine is an investigational vaccine developed by Merck & Company, Inc. (ticker: MRK). It is a vaccine candidate that has been studied in a Phase 1 clinical trial in subjects with chronic hepatitis C. The vaccine is also known as V520.

What is MRKAd5 HIV-1 gag vaccine used for?

MRKAd5 HIV-1 gag vaccine has been studied in a Phase 1 clinical trial for use in subjects with chronic hepatitis C. It is an investigational vaccine and is not approved for any indication.

Who makes MRKAd5 HIV-1 gag vaccine?

MRKAd5 HIV-1 gag vaccine is developed by Merck & Company, Inc., which trades under the ticker symbol MRK.

What phase is MRKAd5 HIV-1 gag vaccine in?

MRKAd5 HIV-1 gag vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA for any indication.

What clinical trials is MRKAd5 HIV-1 gag vaccine in?

MRKAd5 HIV-1 gag vaccine has been evaluated in one completed Phase 1 clinical trial, NCT00857311, titled "MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022)." The trial enrolled 17 participants and was randomized, double-blind, and sham-controlled.

Is MRKAd5 HIV-1 gag vaccine the same as V520?

Yes, MRKAd5 HIV-1 gag vaccine is also known as V520. The alternative name V520 appears in the trial identifier for the Phase 1 study NCT00857311.