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 Accelerated Schedules

This study has been completed.
Sponsor:
Collaborator:
Immuno-US
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000957
First received: November 2, 1999
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

To evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; 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 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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
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 Accelerated Schedules

Resource links provided by NLM:


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

Enrollment: 30
Study Completion Date: August 1993
Detailed Description:

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

Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. Subjects are followed for 1 year after the last injection. Per 05/13/94 amendment, 10 subjects at the St. Louis University site receive an additional boost 18-24 months after the last injection.

  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 1 year of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • They or their sexual partners have identifiable high-risk behavior for HIV infection.
  • Positive syphilis serology (e.g., VDRL).
  • Positive for circulating hepatitis B antigen.

Patients with the following prior conditions are excluded:

  • History of positive PPD (tuberculin test).
  • History of immunodeficiency or chronic illness.
  • Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

  • Immunosuppressive medications.

Prior Treatment:

Excluded:

  • Blood transfusions or cryoprecipitates within the past 6 months.

Risk Behavior: Excluded:

  • High-risk behavior for HIV infection.
  • History of intravenous drug use.
  • More than one sexual partner in the last 6 months.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000957

Locations
United States, Missouri
St. Louis Univ. School of Medicine AVEG
St. Louis, Missouri, United States, 63104
United States, Pennsylvania
JHU AVEG
Pittsburgh, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Immuno-US
Investigators
Study Chair: Belshe R
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000957     History of Changes
Other Study ID Numbers: AVEG 004B, 10545
Study First Received: November 2, 1999
Last Updated: April 26, 2012
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
Drug Evaluation
HIV Envelope Protein gp160
Drug Administration Schedule
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Vaccinia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Poxviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on October 16, 2014