Completed

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months

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What is being tested

rgp120/HIV-1 SF-2

Biological
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
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: October 30, 2012
Sourced from a government-validated database.Claim as a partner

Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest. Ten healthy volunteers receive 200 mcg gp120 in MF59 emulsion, and four volunteers receive placebo consisting of MF59 emulsion in PBS vehicle. Injections are given at months 0, 1, and 6. Patients are followed for 12 months following the third injection.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 30, 2012
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

14 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

Inclusion Criteria Subjects must have: Normal history and physical exam. Negative ELISA for HIV. Normal cell-mediated immune responses using Merieux skin test. Normal urinalysis. Exclusion Criteria Co-existing Condition: Subjects with the following conditions are excluded: Evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements. Positive syphilis serology. If serology is documented as a false positive or is due to a remote (> 6 months) treated infection, subject is eligible. Circulating hepatitis B surface antigen. Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. History of anaphylaxis or other adverse reactions to vaccines. Prior Medication: Excluded: Prior HIV vaccines. Immunoglobulins or vaccines within the past 3 months. Experimental agents within the past 30 days. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 3 months. Identifiable high-risk behavior for HIV infection, including: Any history of intravenous (IV) drug use within the past year. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

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

Vanderbilt Univ Hosp

Nashville, United StatesOpen Vanderbilt Univ Hosp in Google Maps

Univ of Washington / Pacific Med Ctr

Seattle, United States
Completed2 Study Centers