Completed

A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+14

+ 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: January 28, 2026
Sourced from a government-validated database.Claim as a partner

ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of HIV-1 in the United States, has been developed. A previous study showed that a combination vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine, resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN rgp160 vaccine merits investigation. AMENDED 8/94: Volunteers are randomized to receive 800 mcg MN rgp160 vaccine (Immuno-AG) or adjuvant control (placebo) on one of two dosing schedules. Sixteen volunteers receive candidate vaccine and four volunteers receive placebo. ORIGINAL (replaced): Volunteers are randomized to receive either HIVAC-1e on days 0 and 56 followed by immunization with MN rgp160 vaccine on days 224 and 364, or DryVax control on days 0 and 56 followed by placebo on days 224 and 364. Ten volunteers are entered on the MN rgp160 vaccine arm and two volunteers on the placebo arm. PER AMENDMENT 7/96: Two additional booster immunizations of 600 mcg of MN rgp 120/HIV-1 vaccine given at study months 22 and 24 to consenting St. Louis University volunteers.

Official TitleA Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
NCT00001043
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 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

20 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 DiseasesDNA Virus InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPoxviridae InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVacciniaVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

Criteria

Inclusion Criteria Subjects must have: * Normal history and physical exam. * Negative test for HIV by ELISA within 6 weeks prior to immunization. * Negative test for HIV by Western blot. * CD4 count \>= 400 cells/mm3. * No history of smallpox vaccination. * Normal urine dipstick with esterase and nitrate. * No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications. Exclusion Criteria Co-existing Condition: Subjects with the following conditions are excluded: * Positive for hepatitis B surface antigen. * Medical or psychiatric condition or occupational responsibilities that preclude compliance. * Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (\> 6 months) infection, subject is eligible). * Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible). * Eczema. Household contact with persons meeting any of the following criteria: * pregnancy, \< 12 months of age, eczema, or immunodeficiency disease or use of immunosuppressive medications. Subjects with the following prior conditions are excluded: * History of anaphylaxis or other serious adverse reactions to vaccines. * Eczema within the past year. * PER 8/94 AMENDMENT: History of cancer unless surgically excised with reasonable assurance of cure. * PER 8/94 AMENDMENT: History of serious allergic reaction requiring hospitalization or emergent medical care. Prior Medication: Excluded: * Prior HIV vaccines. * Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations. * Experimental agents within the past 30 days. Prior Treatment: Excluded: * Blood products or immunoglobulin within the past 6 months. Higher risk behavior for HIV infection as determined by screening questionnaire, including: * History of injection drug use within 12 months prior to study entry. * Higher or intermediate risk sexual behavior.

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

St. Louis Univ. School of Medicine AVEG

St Louis, United StatesOpen St. Louis Univ. School of Medicine AVEG in Google Maps
Suspended

UW - Seattle AVEG

Seattle, United States
Completed2 Study Centers