Oral Microparticulate Multivalent HIV-1 Peptide Vaccine for Immune Response Induction
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
This study focuses on finding a way to prevent HIV-1 infection. Researchers are testing a new oral vaccine called UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen. This vaccine is unique because it's designed to gradually break down over time, potentially stimulating both local and overall immune responses. The study is important because current vaccine formulations may not provide all the necessary characteristics for an effective HIV vaccine. This research aims to address these challenges and meet the unmet needs in HIV prevention. Participants in this study will be given the oral vaccine at months 0, 1, and 6. There are two dose regimens: either a low dose taken daily for 3 days, or a single higher dose. For each regimen, 12 volunteers will receive the vaccine, while 4 volunteers will receive a placebo. Participants will be monitored for a year, and then contacted once or twice yearly for the next 5 years to check on their health status. The study measures the safety and immune response triggered by the vaccine.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 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
Criteria
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 2 locations
Johns Hopkins Univ / Ctr for Immunological Research
Baltimore, United StatesOpen Johns Hopkins Univ / Ctr for Immunological Research in Google MapsUniv of Rochester Med Ctr
Rochester, United States