Clinical Trial: Anthrax Vaccine Clinical Trials
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Anthrax Vaccine Clinical Trials
Brief Summary:
This study will examine the recombinant, that is, produced by genetic engineering, protective antigen (rPA) that brings about antibodies to neutralize the anthrax toxin and that could therefore be predicted to offer protection against anthrax. Today, anthrax is rarely encountered in the United States, since the introduction of vaccines for cattle in the 1930s. A human vaccine was licensed in 1970. Vaccination against anthrax has been confined to people at risk, such as wool sorters and some veterinarians. However, the rising prospects of B. anthracis being used as a weapon have led to routine administration of the anthrax vaccine to members of the armed forces.
Adults who are in good health may be eligible for this study. The involvement of 300 adults is planned.
Participants will have a general physical exam and test for vital signs. There will also be collection of blood for chemistry and hematology; urinalysis; tests for HIV, hepatitis B and C, and liver function; and a pregnancy test, if applicable.
On a random basis, patients will receive one of the rPA formulations. Two doses of rPA will be evaluated, 10 microgram ((Micro)g) and 20 (Micro)g. This evaluation aims to establish the safety and most desirable level of dosage. Patients will receive one injection of the vaccine, administered in the left shoulder or left thigh. About 30 minutes later, their temperature will be taken, and the injection site will be inspected. Rare but severe reactions could occur if there is extreme sensitivity to a vaccine. However, such an occurrence is extremely rare following a vaccine, and if there are any dangerous symptoms, they can be effectively treated by medications available to patients while they are at the clinic. If there are no significant abnormal results, patients may return
Detailed Summary:
Anthrax is rarely encountered in the U.S. since the introduction of attenuated vaccines for cattle in the 1930's. A vaccine for humans, composed of a cell-free preparation absorbed onto alum, was licensed in 1970 after successful clinical trials. Vaccination against anthrax in the U.S. was confined to individuals at risk such as wool sorters and some veterinarians until the prospects were raised of B. anthracis being used as a weapon after the Iraq war. Now anthrax vaccine is administered routinely to the armed forces. Interest in improving this vaccine was stimulated by the use of B. anthracis spores for bioterrorism.
The active component of the investigational vaccine is called the protective antigen. When B. anthracis invades the host tissues, the protective antigen activates two other proteins to form anthrax toxin. The symptoms of anthrax are caused by this toxin. Alone, the protective antigen has no known toxicity. The gene for this protein has been isolated and changed specifically to improve its properties as a vaccine-this recombinant protective antigen (rPA) elicits antibodies that neutralize the anthrax toxin and, thereby, can be predicted to confer protection.
This is the first study of our investigational rPA vaccine in humans. The broad objectives are to characterize the safety and serum antibody levels of different doses and formulations of rPA in comparison to the licensed anthrax vaccine, AVA.
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: June 15, 2005
Date Started: September 8, 2004
Date Completion:
Last Updated: January 24, 2017
Last Verified: March 16, 2012
