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Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men

NCT00865566 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2504

Last updated 2021-10-15

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.

NOTES:

As of April 2013, all vaccinations in this study have been stopped.

As of June 2017, this study has been closed.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA plasmid vaccine

4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid

BIOLOGICAL

Recombinant adenoviral serotype 5 (rAD5) vector vaccine

1 x 10\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

BIOLOGICAL

DNA vaccine placebo

1 mL IM via Biojector® in either deltoid

BIOLOGICAL

HIV-1 recombinant adenovirus vaccine placebo

1 mL administered IM by needle and syringe in either deltoid

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Scott Hammer · Columbia University

  • Magdalena Sobieszczyk · Columbia University

  • Michael Yin · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2017-10-06
Completion
2017-10-06

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865566 on ClinicalTrials.gov