Completed

Oral Microparticulate Multivalent HIV-1 Peptide Vaccine for Immune Response Induction

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects
NCT00000798
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
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.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

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 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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

Criteria

5 inclusion criteria required to participate
Normal history and physical exam.

HIV negativity by ELISA within 8 weeks of study entry.

Absolute CD4 count >= 400 cells/mm3.

Normal urine dipstick with esterase and nitrite.

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17 exclusion criteria prevent from participating
Positive hepatitis B surface antigen.

Medical or psychiatric condition (such as psychosis or suicidal tendencies) or occupational responsibilities that preclude study compliance.

Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.

Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.

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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 2 locations

Suspended

Johns Hopkins Univ / Ctr for Immunological Research

Baltimore, United StatesOpen Johns Hopkins Univ / Ctr for Immunological Research in Google Maps
Suspended

Univ of Rochester Med Ctr

Rochester, United States
Completed2 Study Centers