Completed

Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant

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What is being tested

rgp120/HIV-1 SF-2

+ MTP-PE/MF59
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: October 30, 2012
Sourced from a government-validated database.Claim as a partner

Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59 emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months. Part B: To evaluate the safety and immunogenicity of gp120 in MF59 when administered in five monthly injections. One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine. One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promising adjuvant and has been selected for studies with the gp120 vaccine. In Part A, 32 volunteers (eight on each of four treatment arms) are randomized to receive one of two doses (15 or 50 mcg) of gp120 vaccine with either MTP-PE/MF59 adjuvant emulsion or MF59 emulsion alone. The volunteers receive three IM injections at 0, 1, and 6 months. In Part B, 16 female volunteers (eight on each of two treatment arms) are randomized to receive either MF59 emulsion alone (placebo) or MF59 emulsion plus gp120 vaccine (50 mcg). Volunteers receive five IM injections at monthly intervals.

Official TitleA Phase I Clinical Trial to Evaluate:Part A. The Safety and Immunogenicity of Two Dose Levels of SF-2 gp120 (CHO) With or Without MTP-PE Adjuvant in the MF59 Emulsion Part B. The Safety and Immunogenicity of Five Monthly Doses of 50 mcg gp120 Protein in MF59 Emulsion (Without MTP-PE) Versus the Emulsion Control 
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
48 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: * Normal history and physical exam. * No identifiable high-risk behavior for HIV infection. * Negative ELISA for HIV. * Normal cell-mediated immune responses using Merieux skin test. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Significant evidence of depression. * Positive syphilis serology (e.g., RPR) that is documented not to be a false positive or from a remote (\> 6 months) treated infection. * Circulating Hepatitis B antigenemia. * More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months. Patients with the following prior conditions are excluded: * History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. * Significant evidence of depression or under treatment for psychiatric problems within the past year. * History of anaphylaxis or other adverse vaccine reactions. * Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) within the past 6 months. Prior Medication: Excluded: * Immunoglobulin or vaccines within the past 2 months. * Experimental agents within the past 30 days. Prior Treatment: Excluded: * Blood transfusions or cryoprecipitates within the past 3 months. Risk Behavior: Excluded: * History of IV drug use within the past year. * More than two sexual partners, or sexual contact with a high-risk partner, within 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 4 locations
Suspended
St Louis Univ School of MedicineSt Louis, United StatesSee the location
Suspended
Univ of Pennsylvania at PhiladelphiaPhiladelphia, United States
Suspended
Vanderbilt Univ HospNashville, United States
Suspended
Children's Hospital & Medical Center / Seattle ACTUSeattle, United States

Completed4 Study Centers