Clinical trial NCT00002428: A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Vaccines, Synthetic
HIV-1
HIV Envelope Protein gp120
AIDS Vaccines
HIV Seronegativity
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Univ of California at San Francisco Gen Hosp
state: California
Study officials:
References:
citation: 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. doi: 10.1016/s0264-410x(01)00051-2.