A 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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-10-30
48
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
Trial Site Locations
How is the study designed?
Frequently Asked Questions
Research Publications
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
B
Biocine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant
Who Can Participate
Age: 18Years - 60Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication
Currently pregnant or breastfeeding
Recent participation in another clinical trial within the last 30 days
Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 4 locations
1
St Louis Univ School of Medicine
St Louis, Missouri, United States, 63104
Status Unknown
2
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
3
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
Status Unknown
4
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
PREVENTION
Number of Arms
0
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Safety and immunogenicity of a candidate HIV-1 vaccine in healthy adults: recombinant glycoprotein (rgp) 120. A randomized, double-blind trial. NIAID AIDS Vaccine Evaluation Group.
Clinical and immunologic responses to human immunodeficiency virus (HIV) type 1SF2 gp120 subunit vaccine combined with MF59 adjuvant with or without muramyl tripeptide dipalmitoyl phosphatidylethanolamine in non-HIV-infected human volunteers.