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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002428
• Other study ID #: 091
• Secondary ID: UBI V106
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• HIV-1 Peptide Vaccine, Microparticulate Monovalent

• rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine

Locations

Country	Name	City	State
United States	Univ of California at San Francisco Gen Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
United Biomedical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lambert JS, Keefer M, Mulligan MJ, Schwartz D, Mestecky J, Weinhold K, Smith C, Hsieh R, Moldoveanu Z, Fast P, Forrest B, Koff W. A Phase I safety and immunogenicity trial of UBI microparticulate monovalent HIV-1 MN oral peptide immunogen with parenteral boost in HIV-1 seronegative human subjects. Vaccine. 2001 Apr 30;19(23-24):3033-42. — View Citation