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Sponsors and Collaborators: |
PharmAthene UK Limited National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | PharmAthene UK Limited |
ClinicalTrials.gov Identifier: | NCT00170456 |
This is a dose ranging study comparing different vaccine schedules of rPA vaccine for anthrax. Safety and the capability to induce an immune response will be evaluated.
Condition | Intervention | Phase |
---|---|---|
Prevention of Bacillus Anthracis (Anthrax) Infection |
Biological: rPA vaccine containing alhydrogel |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Parallel-Group Study of the Safety, Tolerability and Immunogenicity of a Range of Doses and Dosing Schedules of Recombinant (rPA Based) Anthrax Vaccine in Healthy Subjects |
Enrollment: | 415 |
Study Start Date: | March 2005 |
Study Completion Date: | February 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Low dose rPA vaccine regime 1
|
Biological: rPA vaccine containing alhydrogel |
2: Active Comparator
Low dose rPA vaccine regime 2
|
Biological: rPA vaccine containing alhydrogel |
3: Active Comparator
High dose rPA vaccine regime 1
|
Biological: rPA vaccine containing alhydrogel |
4: Active Comparator
High dose rPA vaccine regime 2
|
Biological: rPA vaccine containing alhydrogel |
Anthrax is a zoonotic disease, occurring in wild and domestic mammals, caused by the spore forming bacterium Bacillus anthracis. Anthrax occurs in humans when they are exposed to infected animals, tissue from infected animals or when they are directly exposed to B. anthracis or its spores. In the USA, the annual incidence of human anthrax has declined. However, in the USA, shortly after September 11th 2001, there were 22 cases (18 confirmed) of inhaled and cutaneous anthrax infections that were related to contaminated mail. This is a double blind, parallel-group, dose ranging study of rPA anthrax vaccine. The subjects will be blinded as to which dose of rPA vaccine is administered. The primary objectives of this clinical trial are 1.) To evaluate the safety and tolerability associated with different primary immunization doses and schedules of rPA vaccine to enable determination of the optimum dose for future clinical trials and 2.) To evaluate the immunogenicity of different primary immunization doses and schedules of rPA vaccine to enable determination of the optimum schedule for future clinical trials.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A female may be enrolled if one of the following criteria applies:
Either If of child-bearing capacity then: A female is not pregnant or breast feeding AND is routinely using adequate injectable or transdermal (administered at the recommended frequency) or oral contraception (at a stable dose for at least three months prior to the first dose of vaccine) and will continue to do so during the study, augmenting this contraceptive measure with a barrier method OR is sexually abstinent OR is monogamous and has a partner who has had a vasectomy (>1 month previously) OR is using a commonly recognised copper and hormone implanted intrauterine device (IUD) such as TCu-380A, TCu-220C, MLCu-375, Nova-T or LNG-20. In addition, the subject must have a negative blood pregnancy test prior to enrolment into the study and negative urine pregnancy test pre-dose.
Or A female is post menopausal (defined as a female with no menstrual cycle for at least 24 months and of menopausal age (>45 years).
Or A female with no menstrual cycle for between 12 and 24 months and of menopausal age (>45 years) who has a negative blood pregnancy test prior to enrolment into the study and a negative urine pregnancy test pre-dose.
Or A female has been surgically sterilised (confirmed by review of medical record).
Or A female has had a total hysterectomy at least 3 months prior to the start of the study (confirmed by review of medical record).
Exclusion Criteria:
United Kingdom | |
GDRU, Quintiles Ltd | |
London, United Kingdom | |
Simbec Research Limited | |
Merthyr Tydfil, United Kingdom, CF48 4DR |
Principal Investigator: | Timothy Mant, MD | GDRU, London, UK |
Study ID Numbers: | 05-0003, QGUY/2004/AV-rPA/-01 |
Study First Received: | September 9, 2005 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00170456 |
Health Authority: | United States: Food and Drug Administration |
Anthrax vaccine |
Bacterial Infections Gram-Positive Bacterial Infections Anthrax Healthy Aluminum Hydroxide |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Bacillaceae Infections Physiological Effects of Drugs |
Adjuvants, Immunologic Antacids Infection Pharmacologic Actions |