Safety of an HIV DNA Vaccine Given to HIV Uninfected Adults

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

A Phase I Trial to Evaluate the Safety and Immunogenicity of the HIV-1 pGA2/JS2 Plasmid DNA Vaccine Given Intramuscularly (IM) in HIV-1 Uninfected Adults

The purpose of this study is to see if the experimental HIV vaccine pGA2/JS2 is safe and is well tolerated at two different doses. Another important purpose of this study is to observe how the immune system responds to the vaccine at different dose levels.

Vaccines are given to people to help their bodies fight infection. The vaccine being tested in this study is a DNA vaccine. The pGA2/JS2 plasmid DNA vaccine instructs the body to make some HIV proteins. These HIV proteins may trigger an immune response. Because only a few of the many proteins HIV needs are made through DNA vaccination, there is no risk of getting HIV from the vaccination. This and other similar DNA vaccines have been tested for safety in mice, rabbits, and monkeys. The vaccine has been well tolerated at doses to be used in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

DNA vaccination has induced immune responses in animals to a number of viral, bacterial, and parasite derived antigens. Early clinical experiences with HIV DNA vaccines in humans indicate: 1) the tolerability and short-term safety of DNA at doses up to 5000 mcg in humans are excellent; and 2) there is potential for immunogenicity.

The pGA2/JS2 DNA vaccine is part of a planned prime/boost regimen of a DNA vaccine prime followed by a modified vaccinia Ankara (MVA) vaccine boost. In studies in monkeys, a combination of a DNA vaccine and an MVA vaccine protected the monkeys against disease caused by a monkey virus similar to HIV. The current study is an initial investigation of the safety and immunogenicity of the DNA vaccine given alone. The pGA2/JS2 DNA vaccine expresses gag, protease, reverse transcriptase, env, tat, vpu, and rev.

Participants are randomized to 1 of 2 groups. People in Group A receive either 2 injections of a lower dose (300 mcg) of the DNA plasmid vaccine or the placebo control. People in Group B receive either 2 injections of a higher dose (3000 mcg) of the DNA plasmid vaccine or the control. Group B will be enrolled only if the vaccine is found to be safe and well-tolerated during the initial 2-week evaluation of all participants in Group A. Participants receive vaccinations administered at Months 0 and 2. All vaccinations are administered by intramuscular (IM) injection in an outpatient setting. Participants have about 10 clinic visits during this study, including the screening and injection visits. Participants give blood and urine samples at study visits. They are tested for HIV before entering the study and 4 more times during the study. Women who can become pregnant may undergo up to 3 pregnancy tests during the study period.

Study Type

Interventional

Enrollment

30

Phase

  • 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
        • Alabama Vaccine CRS
    • California
      • San Francisco, California, United States
        • San Francisco Vaccine and Prevention CRS
      • San Francisco, California, United States, 94102
        • UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.
    • Washington
      • Seattle, Washington, United States
        • 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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

Participants may be eligible for this study if they:

  • Are between the ages of 18 and 40.
  • Are at low risk of HIV infection.
  • Have access to a participating study site and are available for follow-up for 12 months.
  • Complete a questionnaire to evaluate understanding of the study prior to enrollment.
  • Are willing to receive HIV test results.
  • Are in good general health.
  • Do not have hepatitis B.
  • Are HCV antibody negative or, if HCV antibody positive, are HCV PCR negative.
  • Have had a negative HIV blood test within 8 weeks prior to enrollment.
  • Women of childbearing potential must agree to use acceptable methods of contraception.
  • Note: All inclusion criteria must be assessed within 56 days prior to study entry.

Exclusion Criteria

Participants may not be eligible for this study if they:

  • Have been immunized against smallpox.
  • Have received HIV vaccines or placebo in a previous HIV vaccine trial.
  • Have used drugs that interfere with the immune system within the past 6 months.
  • Have received blood products within 120 days before HIV screening.
  • Have received immunoglobulin within 60 days before HIV screening.
  • Have received a live vaccine within 30 days prior to initial study vaccine administration.
  • Have used investigational research agents within 30 days prior to initial study vaccine administration.
  • Have received a killed vaccine or allergy treatment injections within 14 days of study vaccine administration.
  • Are currently taking anti-TB therapy.
  • Have a history of serious harmful reactions to vaccines.
  • Have a history of immune system disease.
  • Have a history of unstable asthma.
  • Have a history of type I or type II diabetes.
  • Have a history of thyroid disease.
  • Have a history of tissue swelling with serious episodes.
  • Have a history of high blood pressure.
  • Have a history of a bleeding disorder that was diagnosed by a doctor.
  • Have active syphilis.
  • Have a history of cancer, unless it has been surgically removed and in the opinion of the investigator is not likely to recur during the study period.
  • Have a history of a seizure disorder.
  • Have had their spleen removed.
  • Have mental illness that would interfere with compliance with the protocol.
  • Have any other conditions that, in the judgement of the investigator, would interfere with the study.
  • Are pregnant or breast-feeding.
  • Note: All exclusion criteria must be assessed within 56 days prior to study entry.

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
  • 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: Mark Mulligan, University of Alabama at Birmingham

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 Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

August 9, 2002

First Submitted That Met QC Criteria

August 9, 2002

First Posted (Estimate)

August 12, 2002

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 045
  • 10593 (Registry Identifier: 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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