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

NCT00007423 | Completed Phase 1

• 2 other identifiers: HIVNET 00710590
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

HIV Antibodies; HIV-1; AIDS Vaccines; HIV Seronegativity; Uganda; Cross Reactions; HIV Preventive Vaccine

Interventions

ALVAC-HIV MN120TMG (vCP205) BIOLOGICAL

ALVAC-RG Rabies Glycoprotein (vCP65) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Joint Clinical Research Center: collaborator
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator
• Joint UN Programme on HIV/AIDS (UNAIDS): collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• Case Western Reserve University: collaborator

Study Sites (2)

UVRI - IAVI HIV Vaccine Program

Entebbe, Uganda

Location

Joint Clinical Research Center N09-002 CRS

Kampala, Uganda

Location

Related Publications (1)

• 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.

  PMID: 12660934 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

• Roy Mugerwa

  PRINCIPAL INVESTIGATOR

• Jerrold Ellner

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2000
• First Posted: August 31, 2001
• Study Completion: September 1, 2001
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

UG (2)