A Phase 2 interventional study of rPA vaccine containing alhydrogel in Prevention of Bacillus Anthracis (Anthrax) Infection, sponsored by PharmAthene UK Limited. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-09-15.
Sponsored by PharmAthene UK Limited · Phase 2, Interventional, and Prevention
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.
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.
65 studies on the registry are indexed under Anthrax; 11 are open to participants now.
This study's enrollment of 415 is above the median of 100 across 51 interventional studies indexed under Anthrax.
Browse Anthrax studies →PharmAthene UK Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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:
Low dose rPA vaccine regime 1
Biological: rPA vaccine containing alhydrogel
Low dose rPA vaccine regime 2
Biological: rPA vaccine containing alhydrogel
High dose rPA vaccine regime 1
Biological: rPA vaccine containing alhydrogel
High dose rPA vaccine regime 2
Biological: rPA vaccine containing alhydrogel
Safety of rPA vaccine
Immunogenicity of rPA vaccine
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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PharmAthene UK Limited