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Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Uganda
Study Type
Interventional
Intervention
ALVAC-HIV MN120TMG (vCP205)
ALVAC-RG Rabies Glycoprotein (vCP65)
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 HIV Antibodies, HIV-1, AIDS Vaccines, HIV Seronegativity, Uganda, Cross Reactions, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Volunteers may be eligible for this study if they: Are 18 to 40 years of age. Have a negative pregnancy test at time of entry and agree to use birth control for 1 month prior to the first injection and during active follow-up. Have a normal history and physical examination. Are negative for Hepatitis B. Are HIV-negative. Have blood cells that can be infected with Epstein-Barr virus. Are available for follow-up for the study (24 months). Exclusion Criteria Volunteers will not be eligible for this study if they: Have had a sexually transmitted disease or more than 1 sex partner during the previous 12 months. Are pregnant or breast-feeding. Have had immune diseases, chronic illness, or malignancy. Persons who had cancer that was surgically removed and are thought to be cured are eligible. Have used medications that affect the immune system. Have a medical or mental condition or job that may interfere with the study. Have received certain live vaccines within 60 days of study. Other vaccines such as flu or pneumococcal are not excluded but should be received at least 2 weeks away from HIV immunizations. Have used experimental agents within 30 days prior to study. Have received any blood products within the last 6 months. Have syphilis. Have an HIV-positive partner. Have tuberculosis. Have had or currently have severe allergic reactions to vaccines, eggs or neomycin, or any other substance. that required hospitalization or other medical care. Have been immunized or treated for rabies within 6 months of receiving injections. Are poultry workers. Have malaria that has not been treated or has not responded to treatment. Have schistosomiasis.

Sites / Locations

  • UVRI - IAVI HIV Vaccine Program
  • Joint Clinical Research Center N09-002 CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 19, 2000
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Joint Clinical Research Center, MRC/UVRI and LSHTM Uganda Research Unit, Joint UN Programme on HIV/AIDS (UNAIDS), Fogarty International Center of the National Institute of Health, Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT00007423
Brief Title
Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
Official Title
A Phase I Study of the Safety and Immunogenicity of Live Recombinant ALVAC-HIV vCP205 in HIV-1 Uninfected Adult Volunteers in Uganda
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
September 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Joint Clinical Research Center, MRC/UVRI and LSHTM Uganda Research Unit, Joint UN Programme on HIV/AIDS (UNAIDS), Fogarty International Center of the National Institute of Health, Case Western Reserve University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if it is safe to give ALVAC-HIV vCP205, a possible HIV vaccine, and to study the immune responses in adult HIV-1 uninfected volunteers. Uganda has been severely affected by HIV infection and AIDS and has been selected to participate in HIV-vaccine development. The HIV viruses commonly isolated from Uganda are 2 kinds that are not used in making current vaccines. Current vaccines generate several kinds of immune responses. Researchers would like to see if a response to the kind of virus in a current vaccine will also protect people from the viruses commonly found in Uganda.
Detailed Description
The African country of Uganda is severely affected by HIV infection and AIDS and has been selected by the World Health Organization to participate in HIV-vaccine development. The predominant HIV-1 strains isolated from Ugandans are members of clade A and clade D. The only vaccines available for human testing are based on envelope proteins from clade B and clade E viruses. ALVAC-HIV vCP205 is a second generation vaccine that can induce a humoral and cellular response against several antigens. The current study will attempt to extend these findings to determine if the vCP205 vaccine, when administered to Ugandans, can induce cytotoxic T-lymphocyte (CTL) responses that are reactive against the HIV strains prevalent in Uganda. Volunteers are randomized into 1 of 3 groups and receive either the candidate HIV-1 vaccine ALVAC-HIV vCP205, the experimental canarypox rabies vaccine ALVAC-RG, or placebo-ALVAC. Neither the volunteer nor his/her health care professional knows which preparation is being given. Volunteers receive 4 injections over a period of 6 months and are followed for up to 24 months. Clinical observations and monitoring of hematological, chemical, and immunologic parameters are done. Safety is evaluated by monitoring for local and systemic adverse reactions during the course of the trial. Comparative immunogenicity analyses are based on CTL responses to HIV and measures of binding and HIV-specific antibody responses. At each visit, volunteers are counseled on how to avoid HIV exposure and pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Antibodies, HIV-1, AIDS Vaccines, HIV Seronegativity, Uganda, Cross Reactions, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
40 (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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Volunteers may be eligible for this study if they: Are 18 to 40 years of age. Have a negative pregnancy test at time of entry and agree to use birth control for 1 month prior to the first injection and during active follow-up. Have a normal history and physical examination. Are negative for Hepatitis B. Are HIV-negative. Have blood cells that can be infected with Epstein-Barr virus. Are available for follow-up for the study (24 months). Exclusion Criteria Volunteers will not be eligible for this study if they: Have had a sexually transmitted disease or more than 1 sex partner during the previous 12 months. Are pregnant or breast-feeding. Have had immune diseases, chronic illness, or malignancy. Persons who had cancer that was surgically removed and are thought to be cured are eligible. Have used medications that affect the immune system. Have a medical or mental condition or job that may interfere with the study. Have received certain live vaccines within 60 days of study. Other vaccines such as flu or pneumococcal are not excluded but should be received at least 2 weeks away from HIV immunizations. Have used experimental agents within 30 days prior to study. Have received any blood products within the last 6 months. Have syphilis. Have an HIV-positive partner. Have tuberculosis. Have had or currently have severe allergic reactions to vaccines, eggs or neomycin, or any other substance. that required hospitalization or other medical care. Have been immunized or treated for rabies within 6 months of receiving injections. Are poultry workers. Have malaria that has not been treated or has not responded to treatment. Have schistosomiasis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Mugerwa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerrold Ellner
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVRI - IAVI HIV Vaccine Program
City
Entebbe
Country
Uganda
Facility Name
Joint Clinical Research Center N09-002 CRS
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
12660934
Citation
Cao H, Kaleebu P, Hom D, Flores J, Agrawal D, Jones N, Serwanga J, Okello M, Walker C, Sheppard H, El-Habib R, Klein M, Mbidde E, Mugyenyi P, Walker B, Ellner J, Mugerwa R; HIV Network for Prevention Trials. Immunogenicity of a recombinant human immunodeficiency virus (HIV)-canarypox vaccine in HIV-seronegative Ugandan volunteers: results of the HIV Network for Prevention Trials 007 Vaccine Study. J Infect Dis. 2003 Mar 15;187(6):887-95. doi: 10.1086/368020. Epub 2003 Mar 6.
Results Reference
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Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda

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