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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Walter Reed Army Institute of Research (WRAIR) Baylor College of Medicine University of Alabama at Birmingham Emory University Mayo Clinic |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00119067 |
Anthrax Clinical Trial Objectives:
To assess whether:
Additionally for the final report we will assess whether:
Condition | Intervention | Phase |
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Healthy |
Biological: BioThrax or Anthrax Vaccine Adsorbed |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Bio-equivalence Study |
Official Title: | Anthrax Vaccine Adsorbed: Human Reactogenicity and Immunogenicity Trial to Address Change in Route of Administration and Dose Reduction |
Estimated Enrollment: | 1560 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | December 2007 |
This study is a 43-month prospective, randomized, double-blind, placebo-controlled comparison of immunogenicity and reactogenicity elicited by BioThrax given by different routes of administration (SQ versus IM) and dosing regimens (as many as 8 doses versus as few as 4 doses). Sterile saline is used as the placebo where doses are dropped in regimens using AVA, and in the all-placebo study group.
This study is conducted among a total of 1564 healthy adult men and women (18 to 61 years of age) at five sites in the United States. Participants were randomized into one of 6 study groups with 260 participants per group.
One group receives BioThrax given as currently licensed (SQ with 6 doses followed by annual boosters); another group is given placebo IM (130 participants) or SQ (130 participants) in the currently licensed dosing regimen.
The four other groups receive BioThrax IM in modified dosing regimens; placebo is given when a dose of BioThrax is omitted from the licensed dosing regimen. There are a total of 25 required visits for this study, during which all participants receive an injection of vaccine or placebo (8 injections total), have a blood sample drawn (16 or 17 total), and have an in-clinic examination for adverse events (22 total).
Immunogenicity is assessed by assaying 16 serial blood samples obtained from all participants and a 17th sample from a subset of participants before vaccination and at other specified times. Total anti-protective antigen IgG antibody (anti-PA IgG) is quantified using a standardized and validated enzyme-linked immunosorbent assay (ELISA); the primary study endpoints are 4-fold rise in antibody titer and antibody concentration relative to the pre-vaccination titers or assay reactivity threshold. A subset of serum samples is also assayed in an in vitro toxin neutralization assay (TNA) to measure the functional activity of anti-BioThrax antibodies. The kinetics of the immune response to BioThrax are examined at 3 time points in the study and blood samples from a subset of participants will be further tested in correlates of protection and immunogenetics substudies. All adverse events (AEs), including vaccine reactogenicity, are actively monitored. While all AEs will be ascertained among study participants, several endpoints will be defined based on the likelihood of their occurrence and/or their clinical importance. Of primary interest is the occurrence of local AEs such as warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise. Systemic AEs such as fever, fatigue, muscle ache, headache, temperature, and painful axillary adenopathy are also evaluated.
This study is expected to provide the basis for consideration of change in route of BioThrax administration from SQ to IM and reduction in number of vaccine doses required for primary and booster immunization.
There is an interim analysis of data collected through each participant’s first 7 months of this study for consideration in changing the route of BioThrax administration from SQ to IM, and elimination of the 2 week vaccine priming dose.
At the end of the study, the Sponsor will present the entire results of the trial to FDA for consideration in elimination of additional doses from the licensed BioThrax schedule. At that time, the Sponsor will also supplement these data with results from parallel non-human primate challenge studies and additional research on immunologic correlates of protection.
Ages Eligible for Study: | 18 Years to 61 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
gestational diabetes; treated, controlled, uncomplicated hypertension; treated hypo- or hyperthyroidism; cured nonmetastatic cancer; disease-free for 5 years (excluding hematologic malignancies); localized skin cancer, resected (including squamous cell and basal cell carcinomas, participants with a history of melanoma must be disease-free for 5 years); exercise-induced bronchospasm; mild asthma: use of inhalers only for control of symptoms is acceptable (Persons who have required hospitalization for asthma within the previous 2 years or those who require chronic or frequent oral/parenteral steroids will not be eligible; use of low to medium doses of inhaled steroids; history of coronary artery disease, asymptomatic (NYHA Function Class I), on a stable medical regimen. Persons meeting these criteria must be at least 2 years post-myocardial infarction, cardiac bypass surgery, and/or percutaneous coronary intervention (e.g., angioplasty, stent placement, etc) in order to qualify. Persons with a history of cardiac disease must be under the care of a physician.
Exclusion Criteria:
United States, Alabama | |
Dr Scott Parker | |
Birmingham, Alabama, United States | |
United States, Georgia | |
Dr. Harry Keyserling | |
Atlanta, Georgia, United States | |
United States, Maryland | |
Dr Janiine Babcock | |
Silver Spring, Maryland, United States | |
United States, Minnesota | |
Dr. Gregory Poland | |
Rochester, Minnesota, United States | |
United States, Texas | |
Dr. Wendy Keitel | |
Houston, Texas, United States |
Principal Investigator: | Jennifer Wright, DVM | Centers for Disease Control and Prevention |
Study ID Numbers: | CDC-NCID-3344 |
Study First Received: | July 6, 2005 |
Last Updated: | March 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00119067 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anthrax Vaccine Immunogenicity Reactogenicity |
Bacterial Infections Gram-Positive Bacterial Infections Anthrax Healthy |
Bacterial Infections Gram-Positive Bacterial Infections Bacillaceae Infections Anthrax |