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Home > "A" Clinical Trials Conditions > A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160  A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , MicroGeneSys
Synopsis: To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation. Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
Details: Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest. In the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo. At least 30 days later, 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo. Injections are given on days 0, 30, 180, and 365.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Normal history and physical exam. - Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). - T4 count >= 800 cells/mm3. - Normal chest x-ray and urinalysis. - Negative hepatitis B surface antigen. - Negative HIV p24 antigen test. - Normal skin reactivity by Merieux test. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: - Positive PPD. - Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). Subjects with the following prior conditions are excluded: - History of immunodeficiency, chronic illness, or use of immunosuppressive medications. - Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. Prior Treatment: Excluded: - Prior blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including: - Any history of IV drug use. - Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. - More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Total Enrollment: 25
Location and Contact Information:
Overall Study Official:
BelsheR, Study Chair,
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
St Louis Univ School of Medicine
St. Louis, Missouri, 63104
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: AVEG 003B;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000956
Other Hiv Infections Studies:
1. Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection
2. The Safety and Effectiveness of Ganciclovir Used Alone or in Combination with Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients with AIDS
3. The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients with AIDS
4. Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients
5. A Study of Combivir plus Abacavir plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs
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A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
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