Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults

October 13, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study was developed to incorporate HIV genes from multiple virus clades, representing the viral subtypes responsible for about 90% of new HIV infections in the world. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV uninfected individuals.

Participants will be randomly assigned to one of three groups and will be followed for one year. Study injections will be given by needle-free intramuscular injection at the start of study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group 2 will receive 2 injections of the study vaccine (at start and Month 2) and injection of placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit, study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All participants will undergo physical exams, blood and urine tests to assess measures of health, and blood tests to assess HIV infection and immune response to the injections.

Study Type

Interventional

Enrollment

180

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Alabama Vaccine CRS
    • California
      • San Francisco, California, United States, 94102
        • San Francisco Vaccine and Prevention CRS
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Project Brave HIV Vaccine CRS
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp. CRS
      • Boston, Massachusetts, United States, 02215
        • Fenway Community Health Clinical Research Site (FCHCRS)
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis Univ. School of Medicine, HVTU
    • New York
      • Bronx, New York, United States, 10455
        • NY Blood Ctr./Bronx CRS
      • New York, New York, United States, 10003
        • NY Blood Ctr./Union Square CRS
      • New York, New York, United States, 10032
        • HIV Prevention & Treatment CRS
      • Rochester, New York, United States, 14642
        • Univ. of Rochester HVTN CRS
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital's HVTU
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Vaccine CRS
    • Washington
      • Seattle, Washington, United States, 98104
        • FHCRC/UW Vaccine CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Understanding of vaccination procedure
  • Willing to receive HIV test results and provide informed consent
  • Good general health
  • HIV negative
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
  • Not pregnant and agrees to use acceptable forms of contraception

Exclusion Criteria

  • HIV vaccines or placebo in a prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to study
  • Blood products within 120 days prior to study
  • Immunoglobulin within 60 days prior to study
  • Live attenuated vaccines within 30 days prior to study
  • Investigational research agents within 30 days prior to study
  • Medically indicated subunit or killed vaccines within 14 days prior to study
  • Current anti-tuberculosis prophylaxis or therapy
  • Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection
  • Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years)
  • Diabetes mellitus; a participant with past gestational diabetes is not excluded
  • Thyroid disease, including removal of thyroid and diagnoses requiring medication
  • Serious angioedema
  • Hypertension
  • Diagnosis of bleeding disorder
  • Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
  • Seizure disorder requiring medication within the last 3 years
  • Absence of the spleen
  • Mental illness that would interfere with compliance with the protocol
  • Pregnant or breastfeeding
  • Two or more elevated liver function tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Julie McElrath, Fred Hutchinson Cancer Research Center / University of Washington
  • Study Chair: Larry Peiperl, San Francisco Department of Public Health / University of California - San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

November 3, 2003

First Submitted That Met QC Criteria

November 4, 2003

First Posted (Estimate)

November 5, 2003

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVTN 052
  • 10198 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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