Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand

NCT ID: NCT00006327

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2000-08-31

Brief Summary

The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.

Detailed Description

Volunteers are immunized and followed for a minimum of 2 years. Any volunteer that becomes infected with HIV-1 is followed every 4 months post infection for up to 36 months. Behavior effects associated with study participation are assessed.

Conditions

HIV Infections; HIV Seronegativity

Keywords

Recombinant Proteins; HIV-1; AIDS Serodiagnosis; Substance Abuse, Intravenous; Enzyme-Linked Immunosorbent Assay; Blotting, Western; HIV Envelope Protein gp120; AIDSVAX

Study Design

• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

MN rgp120/HIV-1 and A244 rgp120/HIV-1

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Volunteers may be eligible for this study if they:

• Are 20 to 60 years old.
• Are HIV-negative.
• Have used intravenous drugs in the previous 12 months.
• Are available and commit to 3 years of follow-up.
• Have a Thai National ID or its equivalent such as government official ID or state enterprise ID.
• Are able to understand the study and pass a test showing they understand it, and give written informed consent.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

• Have a serious disease or condition, or history of a serious disease or condition such as lymphoma, that would interfere with the study.
• Are HIV-positive.
• Have ever received an experimental HIV-1 vaccine.
• Have had or expect to have any treatments or medications that interfere with the immune system (e.g., long-term use of systemic steroids, chemotherapy, or radiation).
• Have received a vaccine or immunoglobulin within 2 weeks of receiving the first study injection, or other vaccines within 4 weeks of the first study injection.
• Have received immunoglobulins for a long time.
• Have received non-licensed, research agents within 4 weeks of the first study injection.
• Expect to miss study visits or plan to move within 36 months.
• Are pregnant or breast-feeding or plan to become pregnant during the 36-month study period.
• Are women who have sex with men and do not plan to use effective birth control.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VaxGen

INDUSTRY

Sponsor Role: lead

Principal Investigators

Kachit Choopanya

Role: PRINCIPAL_INVESTIGATOR

Locations

Kachit Choopanya

Klongsan / Bangkok, , Thailand

Countries

Thailand

References

Martin M, Vanichseni S, Suntharasamai P, Mock PA, van Griensven F, Pitisuttithum P, Tappero JW, Chiamwongpaet S, Sangkum U, Kitayaporn D, Gurwith M, Choopanya K; Bangkok Vaccine Evaluation Group. Drug use and the risk of HIV infection amongst injection drug users participating in an HIV vaccine trial in Bangkok, 1999-2003. Int J Drug Policy. 2010 Jul;21(4):296-301. doi: 10.1016/j.drugpo.2009.12.002. Epub 2010 Jan 15.

Reference Type: DERIVED

PMID: 20079620 (View on PubMed)

Suntharasamai P, Martin M, Vanichseni S, van Griensven F, Mock PA, Pitisuttithum P, Tappero JW, Sangkum U, Kitayaporn D, Gurwith M, Choopanya K; Bangkok Vaccine Evaluation Group. Factors associated with incarceration and incident human immunodeficiency virus (HIV) infection among injection drug users participating in an HIV vaccine trial in Bangkok, Thailand, 1999-2003. Addiction. 2009 Feb;104(2):235-42. doi: 10.1111/j.1360-0443.2008.02436.x.

Reference Type: DERIVED

PMID: 19149819 (View on PubMed)

Other Identifiers

VAX 003

Identifier Type: -

Identifier Source: org_study_id