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NCT00114621 · ClinicalTrials.gov registry record · Phase 1
Anthrax Vaccine Clinical Trials
A Phase 1 study of Anthrax, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
- 2
- Study locations
NCT00114621: Completed Phase 1 study of Anthrax, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00114621 is a Phase 1 study of Anthrax that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 93 participants, below the 763-participant average among 6 other Anthrax trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00114621, a Phase 1 study of Anthrax, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
- 2
- Study locations
Study 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 partici
Conditions Studied
Interventions
- DRUG Anthrax Vaccine
- PROCEDURE Blood Chemistry
- PROCEDURE Hematology
- PROCEDURE Urinalysis
Study Locations (2)
District of Columbia
- Georgetown University - Washington D.C.
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2004-09-08 |
| Est. Completion | 2011-05-25 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00114621 record still lists
NCT00114621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 763-participant average among 6 other Anthrax trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Anthrax appearing as the primary indexed condition, and to 4 interventions - of which Anthrax Vaccine is the first listed.
NCT00114621 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT00114621 about?
NCT00114621 is a clinical study titled "Anthrax Vaccine Clinical Trials". 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 State...
What is the current status of trial NCT00114621?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2004-09-08. Estimated completion is 2011-05-25.
What conditions does trial NCT00114621 study?
This clinical trial studies the following conditions: Anthrax.
What interventions are being tested in trial NCT00114621?
The interventions under investigation include: Anthrax Vaccine (DRUG), Blood Chemistry (PROCEDURE), Hematology (PROCEDURE), Urinalysis (PROCEDURE).
Who is sponsoring clinical trial NCT00114621?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00114621 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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