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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001076 |
Purpose
To evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox vaccine ALVAC-HIV MN120TMG (vCP205) versus control followed by boost with rgp120/HIV-1 SF2 vaccine in HIV-negative volunteers.
Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: ALVAC-HIV MN120TMG (vCP205) Biological: ALVAC-RG Rabies Glycoprotein (vCP65) Biological: rgp120/HIV-1 SF-2 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules |
| Estimated Enrollment: | 34 |
Frequent injections of ALVAC-HIV vCP205 may result in more rapid induction of cytotoxic T-lymphocytes. This trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of ALVAC-HIV vCP205.
Volunteers are randomized to receive immunization with either ALVAC-HIV vCP205 or ALVAC-RG rabies glycoprotein (vCP65) at days 0, 7, 14, and 21, followed by boost with rgp120/HIV-1 SF2 at days 28 and 84. A third cohort receives ALVAC-HIV vCP65 on the same schedule followed by boost with placebo.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers must have:
Exclusion Criteria
Co-existing Condition:
Volunteers with the following symptoms or conditions are excluded:
Volunteers with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Contacts and Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Missouri | |
| St Louis Univ School of Medicine | |
| St. Louis, Missouri, United States, 63104 | |
| United States, New York | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| Study Chair: | Belshe R |
More Information
| ClinicalTrials.gov Identifier: | NCT00001076 History of Changes |
| Other Study ID Numbers: | AVEG 029 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
|
Vaccines, Synthetic HIV Envelope Protein gp120 AIDS Vaccines |
HIV Seronegativity Avipoxvirus HIV Preventive Vaccine |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Krestin |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Interferon Inducers Radiation-Protective Agents Protective Agents |