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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002428
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996
  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 1

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

Resource links provided by NLM:


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
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: 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:
ClinicalTrials.gov Identifier: NCT00002428     History of Changes
Other Study ID Numbers: 091, UBI V106
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

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

ClinicalTrials.gov processed this record on November 20, 2014