Completed

A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.

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What is being tested

HIV-1 Peptide Vaccine, Microparticulate Monovalent

+ HIV-1 Peptide Immunogen, Multivalent
Biological
Who is being recruted

HIV Infections

From 18 to 60 Years
How is the trial designed

Prevention Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting. After the prescreening, volunteers will be randomized into Group I or Group II. Each group will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh. At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo. Follow up will be conducted.

Official TitleA Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers. 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
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.
Design Details
36 patients to be enrolledTotal 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.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Patients must have or be: * Healthy. * Negative ELISA for HIV. * Negative for Hepatitis B surface antigen. * Normal urine dipstick. * Normal history and physical exam. * Availability for follow-up for planned duration of the study (60 weeks). Risk Behavior: Required: * Lower or intermediate risk sexual behavior as defined by AVEG. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: * Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. * Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (\> 6 months) treated infection, the volunteer is eligible. * Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible. Patients with any of the following prior conditions are excluded: * History of immunodeficiency, chronic illness, malignancy or autoimmune disease. * History of anaphylaxis or other serious adverse reactions to vaccines. * History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy. * History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months. Prior Medication: Excluded: * History of use of immunosuppressive medication. * Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from HIV immunizations. * Use of experimental agents within 30 days prior to study. * Receipt of blood products or immunoglobulin in the past 6 months. * Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial. Risk Behavior: Excluded: * Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection. * History of injection drug use within the last 12 months to enrollment. * Higher risk sexual behavior as defined by AVEG.



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 3 locations
Suspended
Univ of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
Univ of Rochester Med CtrRochester, United States
Suspended
Univ of Washington / Pacific Med CtrSeattle, United States

Completed3 Study Centers