A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.
Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months after the last injection.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Subjects are:
- • Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study.
- • Exclusion Criteria
- Co-existing Condition:
- Subjects with the following conditions or symptoms are excluded:
- • Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment.
- • Circulating hepatitis B antigenemia.
- Subjects with the following prior conditions are excluded:
- • History of immunodeficiency, chronic illness, or autoimmune disease.
- • Evidence of depression or under treatment for psychiatric problems during the past year.
- Prior Medication:
- Excluded:
- • Immunosuppressive medications.
- Prior Treatment:
- Excluded:
- • Blood transfusions or cryoprecipitates within the past 6 months.
- Identifiable high-risk behavior for HIV infection, including:
- • history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
Seattle, Washington, United States
Rochester, New York, United States
Patients applied
Trial Officials
Dolin R
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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