Anthrax Vaccine Clinical Trials
2 other identifiers
interventional
93
1 country
2
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 home. About 6 hours later and daily for 7 days, they will take their temperature and examine the injection site. The vaccine may cause temporary discomfort at the site of injection, and participants may experience a mild fever for 1 or 2 days after vaccination. Patients will receive diary cards, a digital thermometer, and instructions on taking their temperature and measuring redness and swelling at the injection site, as well as for recording aches, muscle pain, or sensitivity to light for 7 days. They will be examined at the clinic at 72 hours following vaccination and also on the 7th day if they have a fever at or above 100.4 , if swelling is at or more than 2 inches, or if they request an exam. Meanwhile, a clinic staff member will call patients and discuss the findings. Then patients will receive a second and third injection of the same vaccine at 2-month intervals. There will also be interviews about patients' health at each visit to the clinic, plus monitoring of the vaccination after 6 hours and for 7 days. One year later, patients will receive a fourth injection of the same vaccine. Direct benefit to participants in this study is not guaranteed, although an antibody response is predicted. The results in this study will help in the development of improved vaccines for anthrax.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2004
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2004
CompletedFirst Submitted
Initial submission to the registry
June 15, 2005
CompletedFirst Posted
Study publicly available on registry
June 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2011
CompletedJuly 2, 2017
March 16, 2012
June 15, 2005
June 30, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Healthy 18 to 45 year-olds of either sex.
You may not qualify if:
- Patients receiving chronic medication, are pregnant or intend to become pregnant during the study.
- Individuals who are HIV positive, have abnormal liver function, had anthrax, or received anthrax vaccine, have received or intend to receive an experimental vaccine or medication within 30 days of injection of the experimental anthrax vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Georgetown University
Washington D.C., District of Columbia, 20007-2197, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
KEPPIE J, HARRIS-SMITH PW, SMITH H. THE CHEMICAL BASIS OF THE VIRULENCE OF BACILLUS ANTHRACIS. IX. ITS AGGRESSINS AND THEIR MODE OF ACTION. Br J Exp Pathol. 1963 Aug;44(4):446-53. No abstract available.
PMID: 14079018BACKGROUNDTurnbull PC, Leppla SH, Broster MG, Quinn CP, Melling J. Antibodies to anthrax toxin in humans and guinea pigs and their relevance to protective immunity. Med Microbiol Immunol. 1988;177(5):293-303. doi: 10.1007/BF00189414.
PMID: 3139974BACKGROUNDSchneerson R, Robbins JB, Taranger J, Lagergard T, Trollfors B. A toxoid vaccine for pertussis as well as diphtheria? Lessons to be relearned. Lancet. 1996 Nov 9;348(9037):1289-92. doi: 10.1016/S0140-6736(96)05243-9. No abstract available.
PMID: 8909384BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clay W. Mash, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 15, 2005
First Posted
June 16, 2005
Study Start
September 8, 2004
Study Completion
May 25, 2011
Last Updated
July 2, 2017
Record last verified: 2012-03-16