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Safety and Immune Response to Preventive HIV Immunization With Adenovirus Serotype 5 or 35 Vector

NCT00801697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2021-10-14

No results posted yet for this study

Summary

This study will evaluate the safety and preliminary immune response to recombinant adenoviral serotype 35 and 5 HIV-1 vaccines in HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA Vaccine

4 mg VRC-HIVDNA044-00-VP administered as 1 mL

BIOLOGICAL

DNA Vaccine placebo

1 mL VRC-PBSPLA043-00-VP

BIOLOGICAL

rAd35

VRC-HIVADV027-00-VP 1 x 10\^10 PU administered as 1 mL

BIOLOGICAL

rAd35 placebo

1 mL VRC-PBSPLA043-00-0VP

BIOLOGICAL

rAd5

4 mg VRC-HIVADV038-00-VP administered as 1 mL

BIOLOGICAL

rAd5 placebo

1 mL VRC-DILUENT013-DIL-VP

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jonathan Fuchs, MD, MPH · SFDPH/UCSF

  • Pierre-Alexandre Bart, MD · CHUV (Lausanne)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-02-28
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT00801697 on ClinicalTrials.gov