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A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001037
  Purpose

To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94 amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 months after the third injection (i.e., at month 17).

A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.


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, Safety Study
Official Title:   A Phase I, Multicenter, Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules

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

Estimated Enrollment:   24

Detailed Description:

A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.

Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0, 1, and 6 or at months 0, 2, and 8. For each immunization schedule, ten volunteers receive vaccine and two volunteers receive placebo. Per amendment, volunteers receive a fourth immunization of 800 or 200 mcg (or placebo) at 9 or 11 months after the third injection (i.e., at month 17) and are followed for 6 months afterward.

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

Criteria

Inclusion Criteria

Subjects must have:

  • Normal history and physical exam.
  • Negative test for HIV by ELISA within 6 weeks prior to immunization.
  • CD4 count >= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrate.
  • No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions are excluded:

  • Positive for hepatitis B surface antigen.
  • Medical or psychiatric condition or occupational responsibilities that preclude compliance.
  • Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible).
  • Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).

Subjects with the following prior conditions are excluded:

  • History of anaphylaxis or other serious adverse reactions to vaccines.

Prior Medication:

Excluded:

  • Prior HIV vaccines.
  • Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
  • Experimental agents within the past 30 days.

Prior Treatment:

Excluded:

  • Blood products or immunoglobulin within the past 6 months.

Higher risk behavior for HIV infection as determined by screening questionnaire, including:

  • History of injection drug use within 12 months prior to study entry.
  • Higher or intermediate risk sexual behavior.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001037

Locations
United States, Missouri
St Louis Univ School of Medicine    
      St. Louis, Missouri, United States, 63104
United States, Washington
Univ of Washington / Pacific Med Ctr    
      Seattle, Washington, United States, 98144

Sponsors and Collaborators

Investigators
Study Chair:     Gorse G    
  More Information


Publications:

Study ID Numbers:   AVEG 013A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00001037
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic  
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
Vaccinia
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
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 December 03, 2008




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