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

This study has been completed.
Sponsor:
Collaborators:
Joint Clinical Research Center
MRC/UVRI Uganda Research Unit on Aids
Joint UN Programme on HIV/AIDS (UNAIDS)
Case Western Reserve University
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00007423
First received: December 19, 2000
Last updated: May 16, 2012
Last verified: May 2012

December 19, 2000
May 16, 2012
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00007423 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
A Phase I Study of the Safety and Immunogenicity of Live Recombinant ALVAC-HIV vCP205 in HIV-1 Uninfected Adult Volunteers in Uganda

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
  • Biological: ALVAC-HIV MN120TMG (vCP205)
  • Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Not Provided
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. 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2001
Not Provided

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00007423
HIVNET 007, 10590
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
  • Joint Clinical Research Center
  • MRC/UVRI Uganda Research Unit on Aids
  • Joint UN Programme on HIV/AIDS (UNAIDS)
  • John E. Fogarty International Center (FIC)
  • Case Western Reserve University
Principal Investigator: Roy Mugerwa
Principal Investigator: Jerrold Ellner
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP