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V526

Phase 1

HIV | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Nov 2, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment147

FDA Designations

No designations recorded

Clinical trial landscape

V526 · 1 trial · 2 indications

Phase 1 1
NCT00850616Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)HIV
COMPLETED147 Analytics
PHASE1COMPLETED
Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)
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Study Endpoints

Primary Endpoints

Safety and tolerability of 3-dose regimen of MRKAd5+6 trigene vaccine as assessed by review of AEs
Week 30
Immune response to MRKAd5+6 trigene vaccine
30 week

Secondary Endpoints

Immune response to MRKAd5+6 trigene vaccine in subjects with preexisting antibodies to Ad5 or Ad6
Week 30
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMRKAd6 Trigene 0.5x10\^9 Ad6 vg
2EXPERIMENTALMRKAd6 Trigene 0.5x10\^10 Ad6 vg
3EXPERIMENTALMRKAd6 Trigene 0.5x10\^11 Ad6 vg
4EXPERIMENTALMRKAd5 Trigene 0.5x10\^10 Ad5 vg
5EXPERIMENTALMRKAd5 Trivalent 1.5x10\^10 Ad5 vg
6EXPERIMENTALMRKAd5+6 Trigene 1x10\^9 Ad vg
7EXPERIMENTALMRKAd5+6 Trigene 1x10\^10 Ad vg
8PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
V526BIOLOGICAL0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26.
Comparator: Placebo to V526BIOLOGICAL0.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subject has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection * Subject agrees to use an acceptable method of birth control through week 52 of the study Exclusion Criteria: * Subject has been given immune globulin or blood products within 30 da...

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Frequently asked questions about V526

What is V526 used for?

V526 is an investigational monoclonal antibody being developed for HIV and HIV infections. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is being studied for its potential role in addressing HIV, a viral infection that affects the immune system.

Who makes V526?

V526 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research to evaluate the safety and efficacy of this investigational monoclonal antibody for HIV.

What phase is V526 in?

V526 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for HIV.

What clinical trials is V526 in?

V526 has one completed Phase 1 clinical trial registered under NCT00850616, titled "Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)." The trial enrolled 147 participants, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.

Is V526 the same as MRKAd5+6 Trigene?

Yes, V526 is also known as MRKAd5+6 Trigene. The completed Phase 1 clinical trial NCT00850616 refers to the drug as MRKAd5+6 Trigene (V526), confirming that both names refer to the same investigational monoclonal antibody being developed for HIV.