Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: HIV; HIV Infections

Treatments: Biological: Comparator: Placebo to V526; Biological: V526

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850616

V526-001

2009_551

Details and patient eligibility

About

A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine

Enrollment: 147 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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 days of first dose of study vaccine
• Subject has been vaccinated with a live virus vaccine within 30 days or an inactivated vaccine within 5 days of first dose of study vaccine
• Subject has known or suspected impaired immune function
• Subject has participated in any other HIV vaccine trial
• Female subject is pregnant or breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 8 patient groups, including a placebo group

1

Experimental group

Description:

MRKAd6 Trigene 0.5x10\^9 Ad6 vg

Treatment:

Biological: V526

2

Experimental group

Description:

MRKAd6 Trigene 0.5x10\^10 Ad6 vg

Treatment:

Biological: V526

3

Experimental group

Description:

MRKAd6 Trigene 0.5x10\^11 Ad6 vg

Treatment:

Biological: V526

4

Experimental group

Description:

MRKAd5 Trigene 0.5x10\^10 Ad5 vg

Treatment:

Biological: V526

5

Experimental group

Description:

MRKAd5 Trivalent 1.5x10\^10 Ad5 vg

Treatment:

Biological: V526

6

Experimental group

Description:

MRKAd5+6 Trigene 1x10\^9 Ad vg

Treatment:

Biological: V526

7

Experimental group

Description:

MRKAd5+6 Trigene 1x10\^10 Ad vg

Treatment:

Biological: V526

8

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Comparator: Placebo to V526