Completed
Safety and Immunogenicity of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Individuals
What is being tested
HIV-1 Peptide Vaccine, Microparticulate Monovalent
+ rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine
Biological
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
From 18 to 50 Years
+14 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 1
Interventional
Summary
Principal SponsorUnited Biomedical
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorUnited Biomedical
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
5 inclusion criteria required to participate
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.
HIV negativity.
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9 exclusion criteria prevent from participating
History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
History of anaphylaxis or other serious adverse reactions to vaccines.
History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
Occupational or other responsibilities that would prevent completion of study.
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Univ of California at San Francisco Gen Hosp
San Francisco, United StatesOpen Univ of California at San Francisco Gen Hosp in Google MapsCompletedOne Study Center