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A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALVAC-HIV MN120TMG (vCP205)
ALVAC-RG Rabies Glycoprotein (vCP65)
rgp120/HIV-1 SF-2
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, Avipoxvirus, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria 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. Lower-risk sexual behavior. Exclusion Criteria 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. Occupational responsibilities that preclude 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. Occupational exposure to birds. 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. Prior Medication: Excluded: Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations. Experimental agents within 30 days prior to study entry. Prior HIV vaccines. Prior rabies immunization. Prior Treatment: Excluded: Blood products or immunoglobulin within 6 months prior to study entry. Identifiable high-risk behavior for HIV infection, such as injection drug use within past 12 months. higher- or intermediate-risk sexual behavior.

Sites / Locations

  • UAB AVEG
  • St. Louis Univ. School of Medicine AVEG
  • Univ. of Rochester AVEG

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001076
Brief Title
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules
Official Title
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2 vaccine in HIV-negative volunteers. Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205.
Detailed Description
Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205. Volunteers are randomized to receive immunization with either ALVAC-HIV vCP205 or ALVAC-RG rabies glycoprotein (vCP65) at days 0, 7, 14, and 21, followed by boost with rgp120/HIV-1 SF2 at days 28 and 84. A third cohort receives ALVAC-HIV vCP65 on the same schedule followed by boost with placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, Avipoxvirus, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
34 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ALVAC-HIV MN120TMG (vCP205)
Intervention Type
Biological
Intervention Name(s)
ALVAC-RG Rabies Glycoprotein (vCP65)
Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1 SF-2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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. Lower-risk sexual behavior. Exclusion Criteria 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. Occupational responsibilities that preclude 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. Occupational exposure to birds. 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. Prior Medication: Excluded: Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations. Experimental agents within 30 days prior to study entry. Prior HIV vaccines. Prior rabies immunization. Prior Treatment: Excluded: Blood products or immunoglobulin within 6 months prior to study entry. Identifiable high-risk behavior for HIV infection, such as injection drug use within past 12 months. higher- or intermediate-risk sexual behavior.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belshe R
Official's Role
Study Chair
Facility Information:
Facility Name
UAB AVEG
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
St. Louis Univ. School of Medicine AVEG
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Univ. of Rochester AVEG
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
Bender TJ, Tang J, Rivers C, Mulligan MJ, Kaslow RA. Grouping by HLA class I supertype does not enhance HLA associations with CTL responses to ALVAC-HIV canarypox vaccine components. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 193)
Results Reference
background
PubMed Identifier
9875578
Citation
Belshe RB, Gorse GJ, Mulligan MJ, Evans TG, Keefer MC, Excler JL, Duliege AM, Tartaglia J, Cox WI, McNamara J, Hwang KL, Bradney A, Montefiori D, Weinhold KJ. Induction of immune responses to HIV-1 by canarypox virus (ALVAC) HIV-1 and gp120 SF-2 recombinant vaccines in uninfected volunteers. NIAID AIDS Vaccine Evaluation Group. AIDS. 1998 Dec 24;12(18):2407-15. doi: 10.1097/00002030-199818000-00009.
Results Reference
background
PubMed Identifier
10930151
Citation
Sabbaj S, Mulligan MJ, Hsieh RH, Belshe RB, McGhee JR. Cytokine profiles in seronegative volunteers immunized with a recombinant canarypox and gp120 prime-boost HIV-1 vaccine. NIAID AIDS Vaccine Evaluation Group. AIDS. 2000 Jul 7;14(10):1365-74. doi: 10.1097/00002030-200007070-00009.
Results Reference
background
Citation
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]
Results Reference
background
Citation
Zolla-Pazner S, Burda S, Belshe R, Duliege AM, Excler JL, Klein M. Prime/boost immunization of humans induces antibodies that react with many HIV-1 clades and neutralize several X4-, R5-, and dual-tropic primary isolates. Keystone Symposium, HIV Vaccine Development: Opportunities and Challenges--AIDS Pathogenesis. 1999 Jan 7-13 [J1:420]
Results Reference
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A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules

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