HIV InfectionsPhase 3NCT00006327
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
A Phase 3 study testing MN rgp120/HIV-1 and A244 rgp120/HIV-1 in people with HIV Infections and HIV Seronegativity, run by VaxGen at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Seronegativity
- What is being tested?
- MN rgp120/HIV-1 and A244 rgp120/HIV-1
- How many people
- 2,500 participants
- Where
- 1 siteThailand
- Study dates
- Mar 1999to Aug 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.
Read the 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
- Being tested
- MN rgp120/HIV-1 and A244 rgp120/HIV-1
- Keywords
- Recombinant Proteins, HIV-1, AIDS Serodiagnosis, Substance Abuse, Intravenous, Enzyme-Linked Immunosorbent Assay, Blotting, Western, HIV Envelope Protein gp120, AIDSVAX
- Medical subject headings
- HIV Infections, Substance Abuse, Intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MN rgp120/HIV-1 and A244 rgp120/HIV-1Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startMar 1999
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Masking
- Double blind
- Enrolment
- 2,500 participants
Sponsor and investigators
- Lead sponsor
- VaxGen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kachit Choopanya, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006327
- Sponsor's protocol ID
- VAX 003
- Status last verified
- Jun 2003
- First submitted
- 2 Oct 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 20079620Suntharasamai 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.
PubMed 19149819
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
- ClinicalTrials.gov ID
- NCT00006327
- Acronym / sponsor ID
- VAX 003
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants
- Lead sponsor
- VaxGenIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- Study completion
- Aug 2000
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MN rgp120/HIV-1 and A244 rgp120/HIV-1 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 20079620Martin 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.
- Derived from this study: PubMed 19149819Suntharasamai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kachit Choopanya principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MN rgp120/HIV-1 and A244 rgp120/HIV-1 in people with HIV Infections and HIV Seronegativity, run by VaxGen at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006327, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.