Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)
A Phase IIa Dose-Refinement Study of the Safety and Immunogenicity of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in Healthy Adults
Sponsor study identifier
Secondary identifiers
interventional
210
0 countries
N/A
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2008
Actual (reported)Study Completion
May 2008
Actual (reported)This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2006
Actual (reported)July 11, 2006
Actual (reported)October 2006
Date type not reportedThis date has not been verified as actual or estimated.
May 2008
Actual (reported)May 2008
Actual (reported)November 4, 2010
Actual (reported)Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks
30 weeks
MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10\^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
An interim analysis of a related study, V520-023 (NCT00095576), showed that the vaccine used in V520-027 (NCT00350623) was not efficacious; therefore, vaccinations in V520-027 were stopped and only a high level summary of safety data was performed.
Medical Monitor
Merck Sharp & Dohme LLC
210 participants (actual enrollment reported by the registry).
First Submitted
July 7, 2006
First Posted
July 11, 2006
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10\^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2008
Actual (reported)Study Completion
May 2008
Actual (reported)Last Updated
August 25, 2015
Results First Posted
November 4, 2010
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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