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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00133484 |
Objectives are: To confirm the safety and tolerability of 2-dose regimens of 100 g rPA vaccines (3 products) administered by the intramuscular (IM) route to healthy adults.To describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the responses to those following administration of Anthrax Vaccine Adsorbed (AVA or BioThraxTM), the currently available vaccine. The primary immunologic outcome is the proportion of volunteers in each group that mounts an antibody response (defined as a 4-fold or greater increase from pre-vaccination to post-vaccination of anti-rPA IgG antibody with a minimal concentration of 10 µg/ml as measured by ELISA). Secondary outcomes are time to peak response and GMC of anti-PA antibody at peak for each group. In addition, the following immunologic assays will be performed: toxin neutralization assay, oral fluid ELISA, antibody avidity, IgG subclasses, and B-cell memory,T-cell memory and effector subpopulations.
Condition | Intervention | Phase |
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Bacillus Anthracis (Anthrax) |
Biological: Anthrax vaccine absorbed made from Bacillus anthracis (AVA) Biological: Recombinant protein antigen (rPA) made from Bacillus anthrax Biological: Recombinant protein antigen (rPA) made from Escherichia coli |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study to Assess the Safety, Tolerability, Immunogenicity, and Optimal Primary Schedule of 3 Recombinant Protective Antigen (rPA) Anthrax Vaccines Administered in Two Intramuscular Doses to Healthy Adults |
Estimated Enrollment: | 270 |
Estimated Study Completion Date: | May 2007 |
Anthrax CVD 3000: A Phase II Study to Assess the Safety, Tolerability, Immunogenicity, and Optimal Primary Schedule of 3 Recombinant Protective Antigen (rPA) Anthrax Vaccines Administered in Two Intramuscular Doses to Healthy Adults aged 18 to 50 years. The targeted number of subjects is 270.The study objectives are:To confirm the safety and tolerability of 2-dose regimens of 100 g rPA vaccines (3 products) administered by the intramuscular (IM) route to healthy adultsTo describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the responses to those following administration of Anthrax Vaccine Adsorbed (AVA or BioThraxTM), the currently available vaccine. The primary immunologic outcome is the proportion of volunteers in each group that mounts an antibody response (defined as a 4-fold or greater increase from pre-vaccination to post-vaccination of anti-rPA IgG antibody with a minimal concentration of 10 µg/ml as measured by ELISA). Secondary outcomes are time to peak response and GMC of anti-PA antibody at peak for each group. In addition, the following immunologic assays will be performed: toxin neutralization assay, oral fluid ELISA, antibody avidity, IgG subclasses, and B-cell memory,T-cell memory and effector subpopulationsThis is a two center study; in which 270 healthy adults aged 18 to 50 years are randomly assigned to 1 of 9 groups; knowledge of rPA product received is double-masked, but schedule and receipt of AVA are unmasked. The duration of study participation is 12 months per volunteer following a screening period of no more than 30 days: administration over a 1- to 4-week period of two doses of IM rPA or 3 doses of SQ AVA with 12-14 follow-up visits. A subset of the approximately 45 volunteers who have agreed to participate in the special immunology subgroup (those with continued antibody responses at 1 year) will be offered extended participation beyond 1 year in which blood is drawn at 18 months, 2 years, 3 years, and 4 years for examination of long-term immune responses.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For women of child-bearing potential, agreement to avoid pregnancy for the 30 days following each vaccination by use of highly effective birth control methods. A highly effective birth control method is defined as one which results in a failure rate less than 1% per year when used consistently and correctly. These methods include but may not be limited to the following:
Exclusion Criteria:
History including, but not limited to, any of the following medical illnesses:
Abnormal physical findings including, but not limited to, the following:
United States, Maryland | |
University of Maryland School of Medicine | |
Baltimore, Maryland, United States, 21201 | |
United States, North Carolina | |
Duke Children's Primary Care | |
Durham, North Carolina, United States, 27704 |
Study ID Numbers: | 04-026, Anthrax CVD 3000 |
Study First Received: | August 19, 2005 |
Last Updated: | March 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00133484 |
Health Authority: | United States: Food and Drug Administration |
Anthrax, rPA |
Bacterial Infections Gram-Positive Bacterial Infections Anthrax Healthy |
Bacillaceae Infections |