HIV InfectionsPhase 1NCT00002402

A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines

A Phase 1 study testing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, MN rgp120/HIV-1 and A244 rgp120/HIV-1 and Aluminum hydroxide in people with HIV Infections, run by VaxGen at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, MN rgp120/HIV-1 and A244 rgp120/HIV-1 and Aluminum hydroxide
How many people: 120 participants
Where: 4 sitesUnited States
Study dates: Start not givento not given
Phase: Phase 1
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Patients must:

Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Fenway Community Health Ctr
Boston, Massachusetts, 02115
Dr Frank Judson / Director of Public Health Dept
Denver, Colorado, 80204
Saint Louis Univ Health Sciences Ctr
St Louis, Missouri, 63110
Johns Hopkins Bloomberg School of Public Health
Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States

The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.

Read the detailed description

Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0, 1, 6, and 12 months:

Arm A: Patients receive 1 of 3 doses of AIDSVAX B/B vaccine (MN rgp120/HIV-1 plus GNE8 rgp120/HIV-1) in alum adjuvant.

Arm B: Patients receive AIDSVAX B/E (MN rgp120/HIV-1 plus A244 rgp120/HIV-1) vaccine in alum adjuvant.

Patients are evaluated at 1 hr, 3 days, and 14 days after each immunization and at 18 months after the first immunization.

An interim analysis is performed after all patients receive the second dose (at 1 month).

Conditions: HIV Infections
Being tested: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, MN rgp120/HIV-1 and A244 rgp120/HIV-1, Aluminum hydroxide
Keywords: HIV-1, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS Vaccines, HIV Seronegativity, Antigens, Viral, Alum Compounds
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Biological
MN rgp120/HIV-1 and A244 rgp120/HIV-1Biological
Aluminum hydroxideBiological

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)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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 1
Primary purpose: Prevention
Enrolment: 120 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00002402
Sponsor's protocol ID: VAX 002
Status last verified: Aug 1998
First submitted: 2 Nov 1999
Last updated: 24 Jun 2005
Results posted: No

Publications

Mayer K, Judson F, Gorse G, Harro C, Peterson M, Zaharias E, Good J, Shibata R, Lee S, Eastman D, Chernow M, Francis D, Berman P. A phase I/II trial to evaluate the safety and immunogenicity of the AIDSVAX B/B vaccine in the United States (final report). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 178)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States
ClinicalTrials.gov ID: NCT00002402
Acronym / sponsor ID: VAX 002
Conditions: HIV Infections
Keywords: HIV-1, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS Vaccines, HIV Seronegativity, Antigens, Viral, Alum Compounds
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants
Lead sponsor: VaxGenIndustry (pharma, biotech, devices)
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 see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.

Detailed description

Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0, 1, 6, and 12 months:

Arm A: Patients receive 1 of 3 doses of AIDSVAX B/B vaccine (MN rgp120/HIV-1 plus GNE8 rgp120/HIV-1) in alum adjuvant.

Arm B: Patients receive AIDSVAX B/E (MN rgp120/HIV-1 plus A244 rgp120/HIV-1) vaccine in alum adjuvant.

Patients are evaluated at 1 hr, 3 days, and 14 days after each immunization and at 18 months after the first immunization.

An interim analysis is performed after all patients receive the second dose (at 1 month).

Study design

Primary purpose: Prevention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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 GNE8 rgp120/HIV-1	Biological	–
MN rgp120/HIV-1 and A244 rgp120/HIV-1	Biological	–
Aluminum hydroxide	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.
BackgroundMayer K, Judson F, Gorse G, Harro C, Peterson M, Zaharias E, Good J, Shibata R, Lee S, Eastman D, Chernow M, Francis D, Berman P. A phase I/II trial to evaluate the safety and immunogenicity of the AIDSVAX B/B vaccine in the United States (final report). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 178)

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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, MN rgp120/HIV-1 and A244 rgp120/HIV-1 and Aluminum hydroxide in people with HIV Infections, run by VaxGen at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 NCT00002402, which also lists 1 linked publication.

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.