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Immune Responses to Two Experimental HIV Vaccines in Healthy Adults

NCT01386489 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-12-16

No results posted yet for this study

Summary

Background:

The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection.

Purpose:

The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines.

Eligibility:

Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements.

Design:

Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests.

The study will have two groups:

\<TAB\>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months.

\<TAB\>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months.

All participants will be asked to provide blood and body fluid samples for testing during the study.

Payment for participation will be provided....

Conditions

  • HIV Negative
  • Adaptive Immunity
  • Innate Immunity

Interventions

BIOLOGICAL

VRC-HIVDNA016-00-VP

BIOLOGICAL

VRC-HIVADV014-00-VP

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Julie E Ledgerwood, D.O. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-17
Primary Completion
2014-03-09
Completion
2014-03-19

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 NCT01386489 on ClinicalTrials.gov