Clinical trial NCT00000632: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
Official title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
HIV Seronegativity
Keywords: Vaccines, Synthetic
Drug Evaluation
Adjuvants, Immunologic
AIDS Vaccines
HIV Preventive Vaccine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Biocine
First posted: 2001-08-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365.

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.

Detailed description: 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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Univ. of Rochester AVEG
state: New York
city: Nashville
country: United States
facility: Vanderbilt Univ. Hosp. AVEG
state: Tennessee
city: Seattle
country: United States
facility: UW - Seattle AVEG
state: Washington
Study officials:
name: Dolin R
role: STUDY_CHAIR
References:
citation: Evans TG, Fitzgerald T, Gibbons DC, Keefer MC, Soucier H. Th1/Th2 cytokine responses following HIV-1 immunization in seronegative volunteers. The AIDS Vaccine Evaluation Group. Clin Exp Immunol. 1998 Feb;111(2):243-50. doi: 10.1046/j.1365-2249.1998.00486.x.
citation: Keefer MC, Graham BS, McElrath MJ, Matthews TJ, Stablein DM, Corey L, Wright PF, Lawrence D, Fast PE, Weinhold K, Hsieh RH, Chernoff D, Dekker C, Dolin R. Safety and immunogenicity of Env 2-3, a human immunodeficiency virus type 1 candidate vaccine, in combination with a novel adjuvant, MTP-PE/MF59. NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1996 May 20;12(8):683-93. doi: 10.1089/aid.1996.12.683.