A Phase I Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of Recombinant Vaccinia Virus Expressing the Envelope Glycoproteins of Human Immunodeficiency Virus

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

AMENDED: An 80 mcg dose of gp160 has been chosen for the booster because this dose has been shown to be safe and immunogenic in previous trials and allows comparison of the late boost in this protocol with the late boost in the protocol in which patients were primed with three doses of gp160. Original design: HIVAC-1e vaccine is a preparation of the envelope protein of HIV (the virus that causes AIDS). The protein is produced by genetic modification in vaccinia virus. The purpose of a vaccine is to produce an artificially increased immunity to a particular disease, in this case, AIDS. Since...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must demonstrate the following clinical and laboratory findings:
• • Normal history and physical examination.
• • Normal chest X-ray (optional).
• • Normal urinalysis.
• • Negative ELISA.
• • Negative Western blot test.
• • Negative HIV culture.
• • No evidence of smallpox vaccination.
• Note:
• • As an operational definition, an individual can be considered "vaccinia naive" only if no scar is observable and the patient claims and/or has evidence of not being vaccinated. If the patient does not know his/her history, it should be presumed that he/she was vaccinated.
• • Exclusion Criteria
• Patients will be excluded from the study for the following reasons:
• • Appearance of or serologic or clinical evidence of HIV infection.
• • Appearance of or serologic or clinical evidence of clinically active viral infections, including mononucleosis, Epstein-Barr virus, cytomegalovirus which may affect HIV immunocompetence.
• • Syphilis, gonorrhea, or any other sexually transmitted diseases including chlamydia or pelvic inflammatory disease in the last 6 months.
• • History of immunodeficiency or chronic illness.
• • Evidence of depression.
• • History of positive PPD (tuberculosis exposure).
• • Positive syphilis serology.
• • Positive for circulating Hepatitis B antigen.
• • Eczema, active or within the past year.
• • Household contact with someone who is pregnant.
• • Household contact with children less than 12 months old.
• • Household contact with anyone with eczema.
• • Household contact with anyone with immunodeficiencies.
• • Vaccinia immunity.
• Note:
• • Current PPD test is required only if Merieux skin reaction to the tuberculin antigen is positive.
• • If the patient does not know his/her vaccine history, it should be presumed that he/she was vaccinated.
• Prior Treatment:
• Excluded within 1 year of study entry:
• • Treatment for psychiatric problems.
• Excluded within 6 months of study entry:
• • Blood transfusions or cryoprecipitates.
• Patients may not have any of the following diseases or symptoms:
• • Appearance of or serologic or clinical evidence of HIV infection.
• • Appearance of or serologic or clinical evidence of clinically active viral infections, including mononucleosis, Epstein-Barr virus, cytomegalovirus which may affect HIV immunocompetence.
• • Syphilis, gonorrhea, or any other sexually transmitted diseases including chlamydia or pelvic inflammatory disease in the last 6 months.
• • History of immunodeficiency or chronic illness.
• • Evidence of depression.
• • Eczema, active or within the past year.
• High risk behavior for human immunodeficiency virus (HIV) infection, including:
• • Any 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 2 sexual partners or sexual contact with a high-risk partner in the last 6 months.