NCT00001055

Brief Summary

To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative volunteers. ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the transmembrane portion of the LAI strain as well as gag and protease.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

November 1, 1997

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Vaccines, SyntheticHIV Envelope Protein gp120AIDS VaccinesHIV SeronegativityAvipoxvirusHIV Preventive Vaccine

Interventions

ALVAC-HIV MN120TMG (vCP205)BIOLOGICAL
ALVAC-RG Rabies Glycoprotein (vCP65)BIOLOGICAL
rgp120/HIV-1 SF-2BIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers must have:
  • Normal history and physical exam.
  • Negative ELISA and Western blot for HIV.
  • CD4 count \>= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrite.
  • Occupational responsibilities that preclude compliance.

You may not qualify if:

  • Co-existing Condition:
  • Volunteers with the following symptoms or conditions are excluded:
  • Positive hepatitis B surface antigen.
  • Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
  • Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
  • Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
  • Allergy to egg products or neomycin.
  • Volunteers with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, autoimmune disease or use of immunosuppressive medications.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • Prior immunization against rabies.
  • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
  • Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
  • History of cancer unless there has been surgical excision that is considered to have achieved cure.
  • Occupational responsibilities that preclude compliance.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UAB AVEG

Birmingham, Alabama, 35294, United States

Location

JHU AVEG

Baltimore, Maryland, United States

Location

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, 63104, United States

Location

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, 37232, United States

Location

UW - Seattle AVEG

Seattle, Washington, 98144, United States

Location

Related Publications (10)

  • Ferrari G, Humphrey W, Corr K, Tartaglia J, Clements-Mann ML, Corey LC, Duliege AM, Excler JL, Weinhold KJ. Frequency and duration of HIV-1 specific cytolytic reactivities elicited in response to candidate AIDS vaccines. HIV Pathog Treat Conf. 1998 Mar 13-19:87 (abstract no 4026)

    BACKGROUND

  • Ferrari G, Humphrey W, McElrath MJ, Excler JL, Duliege AM, Clements ML, Corey LC, Bolognesi DP, Weinhold KJ. Clade B-based HIV-1 vaccines elicit cross-clade cytotoxic T lymphocyte reactivities in uninfected volunteers. Proc Natl Acad Sci U S A. 1997 Feb 18;94(4):1396-401. doi: 10.1073/pnas.94.4.1396.

    PMID: 9037064BACKGROUND

  • Corey L, Weinhold K, Montefiori D, McElrath J, Excler JL, Duliege AM, Stablein D. Combination candidate HIV vaccines using a canarypox vector (vCP205) followed by boosting with gp120(SF-2). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:209 (abstract no LB18)

    BACKGROUND

  • Corey L, Weinhold K, McElrath J, Excler J-L, Duliege AM, Clements ML, Belshe R, Dolin R, Graham B. AVEU 022: safety and immunogenicity of live recombinant canarypox vector containing the envelope, gag and protease genes of HIV-1 in seronegative adult volunteers. Oral Abstract, 11th International Conference on AIDS, Vancouver, Canada, July 7-12, 1996 [Mo.A282]

    BACKGROUND

  • Kaslow RA, Rivers C, Goepfert P, Tang J, El Habib R, Weinhold K, Mulligan MJ. Association of HLA class I alleles with cytotoxic T-lymphocyte (CTL) responses to gag and env in recipients of ALVAC-HIV canarypox vaccines. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 818]

    BACKGROUND

  • Egan MA, Pavlat WA, Tartaglia J, Paoletti E, Weinhold KJ, Clements ML, Siliciano RF. Induction of human immunodeficiency virus type 1 (HIV-1)-specific cytolytic T lymphocyte responses in seronegative adults by a nonreplicating, host-range-restricted canarypox vector (ALVAC) carrying the HIV-1MN env gene. J Infect Dis. 1995 Jun;171(6):1623-7. doi: 10.1093/infdis/171.6.1623.

    PMID: 7769304BACKGROUND

  • Castillo RC, Arango-Jaramllo S, Humphrey W, Weinhold K, Schwartz DH. Vaccine induced CTL activity correlates with resistant phenotype in an in vitro challenge system. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:95 (abstract no 91)

    BACKGROUND

  • Sabbaj S, Corey L, Evans T, Keefer M, Excler JL, Duliege AM, Mulligan MJ, McGhee JR. Cytokine profiles in human PBMC T cell cultures stimulated with HIV antigens in seronegative volunteers immunized with canarypox expressing HIV antigens and boosted with recombinant SF2 GP120. Conf Adv AIDS Vaccine Dev. 1997 May 4-7:215 (Poster 110)

    BACKGROUND

  • Evans T, Corey L, Clements-Mann ML, Weinhold K, Belshe RB, Excler JL, Duliege AM. CD8+ CTL induced in AIDS vaccine evaluation group phase I trials using canarypox vectors (ALVAC) encoding multiple HIV gene products (vCP125, vCP205, vCP300) given with or without subunit boost. Int Conf AIDS. 1998;12:277 (abstract no 495/21192)

    BACKGROUND

  • Carruth LM, Greten TF, Murray CE, Castro MG, Crone SN, Pavlat W, Schneck JP, Siliciano RF. An algorithm for evaluating human cytotoxic T lymphocyte responses to candidate AIDS vaccines. AIDS Res Hum Retroviruses. 1999 Jul 20;15(11):1021-34. doi: 10.1089/088922299310539.

    PMID: 10445814BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Corey L

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
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

November 1, 1997

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(6)