Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Biocine |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000972 |
To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant (MTP-PE/MF59, a substance to enhance the immune response to vaccine) in volunteers. To evaluate local and systemic reactions (Part A). To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59 in volunteers (Part B). The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A problem with many immunogens, including candidate HIV vaccines, is that they may evoke relatively weak immune responses, particularly in humans and in nonhuman primates. Thus, there is considerable interest in the development of "adjuvants" (substances that augment immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly promising, and is selected for the studies with this HIV vaccine candidate.
Condition | Intervention | Phase |
---|---|---|
HIV Infections HIV Seronegativity |
Biological: MTP-PE/MF59 Biological: Env 2-3 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Safety Study |
Official Title: | A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 |
Estimated Enrollment: | 64 |
The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A problem with many immunogens, including candidate HIV vaccines, is that they may evoke relatively weak immune responses, particularly in humans and in nonhuman primates. Thus, there is considerable interest in the development of "adjuvants" (substances that augment immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly promising, and is selected for the studies with this HIV vaccine candidate.
This study is being conducted in two parts: Part A examines the safety of the adjuvant MTP-PE/MF59 alone; Part B examines the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59. In Part A, three volunteers receive MTP-PE/MF59, and one volunteer receives emulsion alone at each dose level. Initiation of each dose level is separated by at least 72 hours. Doses of adjuvant emulsion are administered at day 0 and day 30 for the highest tolerated dose. If significant reactions are encountered, additional subjects may be studied at lower doses. In Part B, six doses of MTP-PE adjuvant (0, 5, 10, 25, 50, or 100 mcg) in the MF59 emulsion are studied. Six volunteers receive Env 2-3/MTP-PE/MF59 and two receive MTP-PE/MF59 alone at each dose level. There is a minimum 1-week interval between dose escalations. Per amendment, volunteers may receive an additional dose of Env 2-3 or placebo in MF59 emulsion only, administered 12-18 months post initial inoculation.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers are:
Part A:
Part B:
Exclusion Criteria
Co-existing Condition:
Volunteers with the following conditions or symptoms are excluded: Part B:
Circulating hepatitis B antigenemia.
-
Volunteers with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded: Part B:
Risk Behavior: Excluded: Part B: Identifiable high-risk behavior for HIV infection, including:
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Tennessee | |
Vanderbilt Univ Hosp | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Children's Hospital & Medical Center / Seattle ACTU | |
Seattle, Washington, United States, 981050371 |
Study Chair: | Dolin R |
Study ID Numbers: | AVEG 005A/B |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000972 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic Drug Evaluation Adjuvants, Immunologic AIDS Vaccines HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |