AzTrials
AzTrials

HIV InfectionsPhase 2NCT00000871

A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers

A Phase 2 study testing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, MN rgp120/HIV-1 and A244 rgp120/HIV-1 and ALVAC-HIV MN120TMG (vCP205) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. [AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy 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 ALVAC-HIV MN120TMG (vCP205)
How many people
420 participants
Where
18 sitesUnited States
Study dates
Start not givento Jan 2000
Phase
Phase 2
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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must have:
  • Negative ELISA for HIV within 8 weeks of immunization.
  • Normal history and physical examination.
  • Availability for follow-up for planned duration of at least 24 months and willing to have 2 brief evaluations at 36 and 48 months.

Who cannot join

  • Co-existing Condition:
  • Participants with the following symptoms or conditions are excluded:
  • Active syphilis.
  • NOTE:
  • AS PER AMENDMENT 6/25/97:
  • Participant eligible if the serology is documented to be a false positive or due to adequately treated infection.
Show all 26Show fewer
  • Active tuberculosis (TB).
  • NOTE:
  • Participant eligible if positive purified protein derivative and normal chest x-ray shows no evidence of TB and does not require isoniazid therapy.
  • Participants with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, malignancy, idiopathic anaphylaxis (AS PER AMENDMENT 6/25/97) or autoimmune disease. Participants with a history of cancer are excluded unless they have undergone surgery followed by a sufficient observation period to give a reasonable assurance of cure.
  • Any history of anaphylaxis or history of other serious adverse reactions to vaccines.
  • Immediate-type hypersensitivity reaction to egg products or neomycin (used to prepare ALVAC vaccines).
  • Prior Medication:
  • Excluded:
  • Immunosuppressive medications.
  • Live attenuated vaccines within 60 days of study.
  • Use of investigational agents within 30 days prior to study.
  • Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.
  • Prior Treatment:
  • Excluded:
  • Receipt of blood products or immunoglobulin within past 6 months.
  • Risk Behavior:
  • Excluded:
  • Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol. Specifically excluded are persons with a history of suicide attempts within 3 years, recent suicidal ideation or who have past or present psychosis.
  • Medically indicated subunit or killed vaccines, e.g., influenza, pneumococcal, hepatitis A and B allowed provided administered more than 2 weeks from HIV study immunizations.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • JHU AVEG

    Baltimore, Maryland, 21205

  • UAB AVEG

    Birmingham, Alabama, 35294

  • Fenway Community Health Center HIVNET

    Boston, Massachusetts, 02115

  • Cook County Hospital HIVNET

    Chicago, Illinois, 60612

  • Univ. of Illinois at Chicago HIVNET

    Chicago, Illinois

  • Denver Dept. of Health HIVNET

    Denver, Colorado

  • Denver Public Health CRS

    Denver, Colorado

  • Vanderbilt Univ. Hosp. AVEG

    Nashville, Tennessee, 37232

  • NY Blood Ctr. HIVNET

    New York, New York, 10016

  • NY Univ. Med. Ctr. HIVNET

    New York, New York, 10016

  • Univ. of Pennsylvania HIVNET

    Philadelphia, Pennsylvania, 19104

  • Memorial Hosp. of Rhode Island HIVNET

    Providence, Rhode Island, 02906

  • The Miriam Hosp. HIVNET

    Providence, Rhode Island, 02906

  • Univ. of Rochester AVEG

    Rochester, New York, 14642

  • Public Health Enterprises Foundation, Inc. HIVNET

    San Francisco, California

  • UW - Seattle AVEG

    Seattle, Washington

  • Uw Hivnet

    Seattle, Washington

  • St. Louis Univ. School of Medicine AVEG

    St Louis, Missouri

Other trials in United States

About this study

To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. [AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of HIV-1 in the context of previous immunization with a canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205 alone.] In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.]

Read the detailed description

In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.]

Volunteers are recruited and screened; those who are enrolled are then stratified by their risk status into 2 groups: individuals having lower-risk behavior for HIV and individuals having higher-risk behavior for HIV. Volunteers are then randomly assigned to arm A, B, or C and receive immunizations at months 0, 1, 3, and 6 as follows:

Group A- ALVAC vCP205 plus SF-2 rgp120 in MF59. Group B- ALVAC vCP205 plus saline placebo. Group C- Placebo-ALVAC plus saline placebo. [AS PER AMENDMENT 7/2/98: Beginning 12-18 months after initial vaccination, then 2, 6, and 12 months later, 10 volunteers from group A receive saline placebo, while 50 volunteers each from groups B and C are rerandomized within their respective groups, and are treated as follows.

Group B (subgroup 1) - AIDSVAX B/B. Group B (subgroup 2) - AIDSVAX B/E. Group B (subgroup 3) - alum placebo. Group C (subgroup 1) - AIDSVAX B/B. Group C (subgroup 2) - AIDSVAX B/E. Group C (subgroup 3) - alum placebo.] Volunteers are followed for 2 years and are tested for humoral immune response to HIV-1. Neutralizing activity to HIV-1 is performed on a subset of volunteers monitored for CTL response. [AS PER AMENDMENT 7/2/98: Volunteers receiving AIDSVAX B/B and AIDSVAX B/E will additionally be studied for formation of various neutralizing antibodies and parameters of cellular immunity.] [AS PER AMENDMENT 4/30/99: Because the subunit boosts that were added in version 3.0 are not available, the subunit boost portion of version 3.0 is cancelled.]

Conditions
HIV Infections
Being tested
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, MN rgp120/HIV-1 and A244 rgp120/HIV-1, ALVAC-HIV MN120TMG (vCP205), rgp120/HIV-1 SF-2
Keywords
Vaccines, Synthetic, AIDS Vaccines, HIV Seronegativity, Avipoxvirus, HIV Preventive Vaccine
Medical subject headings
HIV Infections

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

  • ALVAC-HIV MN120TMG (vCP205)Biological

  • rgp120/HIV-1 SF-2Biological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionJan 2000

Resources

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 2
Primary purpose
Prevention
Masking
Double blind
Enrolment
420 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000871
Sponsor's protocol ID
AVEG 202/HIVNET 014
Other IDs
HIVNET 014, 10589, AVEG 202
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Belshe RB, Stevens C, Gorse G, Buchbinder S, Sridhara R, Self S, Weinhold K, Sheppard H, Duliege AM, Meignier B, McNamara J, Flores J (NIAID AVEG, HIVNET Vaccine Development Groups). Phase II evaluation of a live recombinant canarypox (ALVAC) vector HIV-1 vaccine with or without gp120 subunit HIV-1 vaccine. 13th Meeting, International Society for Sexually Transmitted Diseases Research, 1999 Jul 11-14 [227].

  • Gorse GJ, Patel GB, Mandava MD, Arbuckle JA, Doyle TM, Belshe RB; National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group. Cytokine responses to human immunodeficiency virus type 1 (HIV-1) induced by immunization with live recombinant canarypox virus vaccine expressing HIV-1 genes boosted by HIV-1(SF-2) recombinant GP120. Vaccine. 2001 Feb 8;19(13-14):1806-19. doi: 10.1016/s0264-410x(00)00378-9.

    PubMed 11166906

  • Belshe RB, Stevens C, Gorse GJ, Buchbinder S, Weinhold K, Sheppard H, Stablein D, Self S, McNamara J, Frey S, Flores J, Excler JL, Klein M, Habib RE, Duliege AM, Harro C, Corey L, Keefer M, Mulligan M, Wright P, Celum C, Judson F, Mayer K, McKirnan D, Marmor M, Woody G; National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group and HIV Network for Prevention Trials (HIVNET). Safety and immunogenicity of a canarypox-vectored human immunodeficiency virus Type 1 vaccine with or without gp120: a phase 2 study in higher- and lower-risk volunteers. J Infect Dis. 2001 May 1;183(9):1343-52. doi: 10.1086/319863. Epub 2001 Apr 10.

    PubMed 11294665

  • Worku S, Gorse GJ, Belshe RB, Hoft DF. Canarypox vaccines induce antigen-specific human gammadelta T cells capable of interferon-gamma production. J Infect Dis. 2001 Sep 1;184(5):525-32. doi: 10.1086/322792. Epub 2001 Jul 26.

    PubMed 11474428

  • Gorse GJ, Patel GB, Belshe RB; National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network. HIV type 1 vaccine-induced T cell memory and cytotoxic T lymphocyte responses in HIV type 1-uninfected volunteers. AIDS Res Hum Retroviruses. 2001 Aug 10;17(12):1175-89. doi: 10.1089/088922201316912781.

    PubMed 11522187

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, MN rgp120/HIV-1 and A244 rgp120/HIV-1 and ALVAC-HIV MN120TMG (vCP205) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 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?

The sponsor lists 4 inclusion and 26 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT00000871, which also lists 5 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 4 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in