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A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects

This study has been completed.

Sponsored by: United Biomedical
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002428
  Purpose

To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers.


Condition Intervention Phase
HIV Infections
Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent
Biological: rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine
Phase I

MedlinePlus related topics:   AIDS   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Double-Blind, Safety Study
Official Title:   A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28, and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0, followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are followed for 1 year.

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria

Volunteers must have:

  • Normal history and physical exam.
  • HIV negativity.
  • CD4 count >= 400 cells/mm3.
  • Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry.
  • Normal urine dipstick with esterase and nitrite.

Exclusion Criteria

Co-existing Condition:

Volunteers with the following symptoms or conditions are excluded:

  • Active tuberculosis.
  • Occupational or other responsibilities that would prevent completion of study.

Volunteers with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
  • Acute gastroenteritis or gastrointestinal surgery within the past 12 months.

Prior Medication:

Excluded:

  • Live or attenuated vaccine within the past 60 days.
  • Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002428

Locations
United States, California
Univ of California at San Francisco Gen Hosp    
      San Francisco, California, United States, 94110

Sponsors and Collaborators
United Biomedical
  More Information


Publications:

Study ID Numbers:   091, UBI V106
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002428
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Vaccines, Synthetic  
HIV-1  
HIV Envelope Protein gp120  
AIDS Vaccines  
HIV Seronegativity  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
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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