Completed

Safety and Immunogenicity Evaluation of UBI HIV-1MN PND Peptide Immunogen and UBI Microparticulate Monovalent HIV-1 MN Branched Peptide in HIV-1 Uninfected Volunteers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

HIV-1 Peptide Vaccine, Microparticulate Monovalent

+ HIV-1 Peptide Immunogen, Multivalent

Biological
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: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00000846
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 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, ViralLentivirus InfectionsHIV Infections

Criteria

7 inclusion criteria required to participate
Availability for follow-up for planned duration of the study (60 weeks)
Healthy
Lower or intermediate risk sexual behavior as defined by AVEG
Negative ELISA for HIV
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15 exclusion criteria prevent from participating
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
Higher risk sexual behavior as defined by AVEG
History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months
Show More 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 3 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Univ of Rochester Med Ctr

Rochester, United States

Univ of Washington / Pacific Med Ctr

Seattle, United States
Completed3 Study Centers