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A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-Mcg Dose

This study has been completed.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Immuno-US
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001056
  Purpose

To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.


Condition Intervention Phase
HIV Infections
Biological: gp160 Vaccine (Immuno-AG)
Phase I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Krestin    PANVAC-V   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Double-Blind, Safety Study
Official Title:   A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-Mcg Dose

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   25

Detailed Description:

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo. At each participating site, four volunteers receive vaccine and two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for 2 years. Volunteers may be offered an additional booster of the same preparation at 12 months.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria

Patients must be:

  • Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
  • Available for 2 years of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • History of positive PPD (tuberculin test) and abnormal chest x-ray.
  • Positive syphilis serology (e.g., RPR).
  • Positive for circulating hepatitis B surface antigen.

Patients with the following are excluded:

  • They or their sexual partners have identifiable high-risk behavior for HIV infection.
  • History of immunodeficiency or chronic illness.
  • Evidence of psychological or psychiatric problems that may lead to noncompliance.

Prior Medication:

Excluded:

  • Immunosuppressive medications.

Prior Treatment:

Excluded:

  • Blood transfusions or cryoprecipitates within the past 6 months.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001056

Locations
United States, Maryland
Johns Hopkins Univ / School of Hygiene & Public Health    
      Baltimore, Maryland, United States, 212051901
United States, Missouri
St Louis Univ School of Medicine    
      St. Louis, Missouri, United States, 63104
United States, New York
Univ of Rochester Med Ctr    
      Rochester, New York, United States, 14642
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia    
      Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Univ Hosp    
      Nashville, Tennessee, United States, 37232
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU    
      Seattle, Washington, United States, 981050371
Univ of Washington / Pacific Med Ctr    
      Seattle, Washington, United States, 98144

Sponsors and Collaborators

Investigators
Study Chair:     Belshe R    
  More Information


Publications:

Study ID Numbers:   AVEG 004A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00001056
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic  
Vaccinia Virus  
Viral Vaccines  
HIV-1  
HIV Envelope Protein gp160
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Poxviridae Infections
Vaccinia
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
DNA Virus Infections
PS-K
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 31, 2008




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