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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00170469 |
Purpose
This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to induce an immune response will be evaluated.
| Condition | Intervention | Phase |
|
Bacillus Anthracis (Anthrax) |
Biological: AVA Biological: Alhydrogel Biological: rPA (Avecia) |
Phase II |
| MedlinePlus related topics: | Anthrax |
| ChemIDplus related topics: | Aluminum hydroxide Algeldrate |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Dose Ranging Multi-Centre, Single Blind, Parallel-Group, Controlled Study of the Safety, Tolerability and Immunogenicity of Recombinant (rPA Based) Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed in a Healthy Population |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | January 2007 |
Anthrax is a zoonotic disease, occurring in wild and domestic mammals, caused by the spore-forming bacterium Bacillus anthracis (B. 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. Depending on the route of infection, anthrax disease can occur in three forms: cutaneous, gastrointestinal, and inhalation. In the United States of America (USA), the annual incidence of human anthrax has declined from approximately 130 cases annually in the early 1900s to no cases during 1999 to 2000. However, in the USA, shortly after September 11th, 2001, there were 22 cases (18 confirmed) of inhaled and cutaneous anthrax infection that were related to contaminated mail. The development of a new anthrax vaccine is necessary because the current AVA vaccine requires the growth of B. anthracis in its manufacturing process and has a complex administration regimen of six administrators of vaccine in 18 months. As protective antigen (PA) is a central virulence factor in anthrax pathogenesis and a major immunogen in the current vaccine, a recombinant, acellular, protective antigen-based anthrax vaccine, could offer an improved manufacturing process and a simpler dosing schedule. Furthermore, the vaccine could offer improved protection against inhaled B. anthracis, and could, when used in conjunction with antibiotics, form part of the management of anthrax exposed individuals. This is a dose ranging study comparing different primary vaccine schedules of rPA Anthrax vaccine to the licensed dose of Anthrax Vaccine Adsorbed. The study is designed to measure the immune response, and to evaluate the safety and tolerability of different doses of rPA Anthrax Vaccine. After subjects have given informed consent, they will undergo physical exams, medical history screening, pregnancy tests, ECG, HIV, Hepatitis B & C tests, safety blood tests, and urine drug and alcohol screen. Subjects will be asked to complete a diary card to record any symptoms they may experience. The subjects that receive AVA will be offered the opportunity to complete the licensed course of vaccination which would involve AVA vaccinations at 6, 12 and 18 months.
Eligibility
| 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 recognized 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 sterilized (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:
Contacts and Locations| United States, Alabama | |||||
| Discovery Alliance, Inc. | |||||
| Mobile, Alabama, United States, 36606 | |||||
| Greater Huntsville Family Practice, PC | |||||
| Huntsville, Alabama, United States, 35802 | |||||
| United States, California | |||||
| Accelovance | |||||
| San Diego, California, United States, 92108 | |||||
| United States, District of Columbia | |||||
| Accelovance | |||||
| Washington, District of Columbia, United States, 20006 | |||||
| United States, Florida | |||||
| Florida Medical Research Institute | |||||
| Gainesville, Florida, United States, 32607 | |||||
| Miami Research Associates | |||||
| South Miami, Florida, United States, 33143 | |||||
| Accelovance | |||||
| Melbourne, Florida, United States, 32935 | |||||
| United States, Illinois | |||||
| Accelovance | |||||
| Orland Park, Illinois, United States, 60462 | |||||
| United States, Indiana | |||||
| Accelovance | |||||
| South Bend, Indiana, United States, 46601 | |||||
| United States, Oklahoma | |||||
| Accelovance | |||||
| Oklahoma City, Oklahoma, United States, 73112 | |||||
| Lynn Health Science Institute | |||||
| Oklahoma City, Oklahoma, United States, 73120 | |||||
| United States, Tennessee | |||||
| McKenzie Medical Center | |||||
| McKenzie, Tennessee, United States, 38201 | |||||
| United States, Texas | |||||
| Accelovance | |||||
| Houston, Texas, United States, 77024 | |||||
| PharamTex Research, Inc. | |||||
| Amarillo, Texas, United States, 79106 | |||||
| United States, Virginia | |||||
| Carilion Medical Associates | |||||
| Galax, Virginia, United States, 24333 | |||||
| Metropolitan Research | |||||
| Fairfax, Virginia, United States, 22031 | |||||
More Information
| Study ID Numbers: | 05-0002, PA-8645-02 |
| First Received: | September 9, 2005 |
| Last Updated: | June 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00170469 |
| Health Authority: | Unspecified |
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