NCT00043511

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2002

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

First QC Date

August 9, 2002

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

Injections, IntramuscularHIV SeronegativityPlasmidsVaccines, DNAHIV Preventive Vaccine

Interventions

pGA2/JS2 Plasmid DNA VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alabama Vaccine CRS

Birmingham, Alabama, United States

Location

UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.

San Francisco, California, 94102, United States

Location

San Francisco Vaccine and Prevention CRS

San Francisco, California, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, United States

Location

Related Publications (4)

  • Robinson HL, Pertmer TM. DNA vaccines for viral infections: basic studies and applications. Adv Virus Res. 2000;55:1-74. doi: 10.1016/s0065-3527(00)55001-5. No abstract available.

    PMID: 11050940BACKGROUND

  • Gurunathan S, Klinman DM, Seder RA. DNA vaccines: immunology, application, and optimization*. Annu Rev Immunol. 2000;18:927-74. doi: 10.1146/annurev.immunol.18.1.927.

    PMID: 10837079BACKGROUND

  • Amara RR, Villinger F, Altman JD, Lydy SL, O'Neil SP, Staprans SI, Montefiori DC, Xu Y, Herndon JG, Wyatt LS, Candido MA, Kozyr NL, Earl PL, Smith JM, Ma HL, Grimm BD, Hulsey ML, Miller J, McClure HM, McNicholl JM, Moss B, Robinson HL. Control of a mucosal challenge and prevention of AIDS by a multiprotein DNA/MVA vaccine. Science. 2001 Apr 6;292(5514):69-74. doi: 10.1126/science.1058915.

    PMID: 11393868BACKGROUND

  • Ramshaw IA, Ramsay AJ. The prime-boost strategy: exciting prospects for improved vaccination. Immunol Today. 2000 Apr;21(4):163-5. doi: 10.1016/s0167-5699(00)01612-1. No abstract available.

    PMID: 10740236BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Mark Mulligan

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2002

First Posted

August 12, 2002

Study Completion

April 1, 2003

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

US(4)