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

NCT00000871 | Completed Phase 2

• 4 other identifiers: AVEG 202/HIVNET 014HIVNET 01410589AVEG 202
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 18

Brief 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. \[AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of HIV-1 in the context of previous immunization with a canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205 alone.\] 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. \[AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.\]

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; AIDS Vaccines; HIV Seronegativity; Avipoxvirus; HIV Preventive Vaccine

Interventions

MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 BIOLOGICAL

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

ALVAC-HIV MN120TMG (vCP205) BIOLOGICAL

rgp120/HIV-1 SF-2 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (18)

UAB AVEG

Birmingham, Alabama, 35294, United States

Location

Public Health Enterprises Foundation, Inc. HIVNET

San Francisco, California, United States

Location

Denver Dept. of Health HIVNET

Denver, Colorado, United States

Location

Denver Public Health CRS

Denver, Colorado, United States

Location

Cook County Hospital HIVNET

Chicago, Illinois, 60612, United States

Location

Univ. of Illinois at Chicago HIVNET

Chicago, Illinois, United States

Location

JHU AVEG

Baltimore, Maryland, 21205, United States

Location

Fenway Community Health Center HIVNET

Boston, Massachusetts, 02115, United States

Location

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States

Location

NY Blood Ctr. HIVNET

New York, New York, 10016, United States

Location

NY Univ. Med. Ctr. HIVNET

New York, New York, 10016, United States

Location

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

Univ. of Pennsylvania HIVNET

Philadelphia, Pennsylvania, 19104, United States

Location

Memorial Hosp. of Rhode Island HIVNET

Providence, Rhode Island, 02906, United States

Location

The Miriam Hosp. HIVNET

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, 37232, United States

Location

UW - Seattle AVEG

Seattle, Washington, United States

Location

Uw Hivnet

Seattle, Washington, United States

Location

Related Publications (5)

• 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].

  BACKGROUND

• 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.

  PMID: 11166906 BACKGROUND

• 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.

  PMID: 11294665 BACKGROUND

• 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.

  PMID: 11474428 BACKGROUND

• 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.

  PMID: 11522187 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Belshe R

  STUDY CHAIR

• Gorse G

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: January 1, 2000
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (18)