UMD rPA Regimen Trial in Adults

NCT00133484 | Terminated Phase 2

• 2 other identifiers: 04-026Anthrax CVD 3000
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

Objectives are: To confirm the safety and tolerability of 2-dose regimens of 100 g rPA vaccines (3 products) administered by the intramuscular (IM) route to healthy adults.To describe the immunologic responses to 2-dose regimens of 3 rPA vaccines and to compare the responses to those following administration of Anthrax Vaccine Adsorbed (AVA or BioThraxTM), the currently available vaccine. The primary immunologic outcome is the proportion of volunteers in each group that mounts an antibody response (defined as a 4-fold or greater increase from pre-vaccination to post-vaccination of anti-rPA IgG antibody with a minimal concentration of 10 µg/ml as measured by ELISA). Secondary outcomes are time to peak response and GMC of anti-PA antibody at peak for each group. In addition, the following immunologic assays will be performed: toxin neutralization assay, oral fluid ELISA, antibody avidity, IgG subclasses, and B-cell memory,T-cell memory and effector subpopulations.

Conditions

Bacillus Anthracis (Anthrax)

Keywords

Anthrax, rPA

Interventions

Anthrax vaccine absorbed made from Bacillus anthracis (AVA) BIOLOGICAL

Recombinant protein antigen (rPA) made from Bacillus anthrax BIOLOGICAL

Recombinant protein antigen (rPA) made from Escherichia coli BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 50 years, inclusive.
• Good health as evidenced by screening evaluation within the 30 days prior to immunization.
• Expressed interest and availability to fulfill the study requirements.
• Signed, informed consents for screening, HIV antibody testing, storing specimens, HIPAA authorization, and protocol-specific research participation.
• For women of child-bearing potential, agreement to avoid pregnancy for the 30 days following each vaccination by use of highly effective birth control methods. A highly effective birth control method is defined as one which results in a failure rate less than 1% per year when used consistently and correctly. These methods include but may not be limited to the following:
• Tubal ligation
• Implantable contraceptive release devices such as Norplant
• Injected contraceptive hormones such as Depo-Provera
• Combined oral contraceptives
• Most IUDs (All commonly used copper and hormone implanted IUDs in the U.S. are highly effective, including the following types: TCu-380A, TCu-220C, MLCu-375, Nova-T, and LNG-20)
• Vaginal ring hormonal release insertion devices such as NuvaRing
• Transdermal hormonal contraceptive methods (patches) such as OrthoEvra, and
• Sexual abstinence
• Agreement to refrain from taking any experimental drug or vaccine from the day of screening to six months after enrollment.

You may not qualify if:

• History including, but not limited to, any of the following medical illnesses:
• Diabetes mellitus (not including gestational diabetes that resolved following parturition)
• Cancer
• Heart disease, including hospitalization for heart attack or pathologic arrhythmia
• Unconsciousness, other than concussions or simple faints (vasovagal/syncopal episodes)
• A seizure disorder (other than simple benign febrile seizures of childhood and petit mal/absence seizures of childhood without manifestations in adulthood)
• Guillain Barré syndrome
• Chronic gastrointestinal diseases (including inflammatory bowel disease and celiac disease; not including history of heartburn, gastritis, peptic ulcer disease, or acute gastrointestinal diseases)
• Recurrent or chronic arthritis, not including overuse injuries or osteoarthritis that does not require daily medication
• Immunodeficiency
• Chronic autoimmune diseases, including systemic lupus erythematosus and autoimmune thyroiditis
• Continuous daily treatment or prophylaxis (other than topical medications) for 6 months duration or more within the last 5 years of a common minor illness such as reactive airway disease, allergic rhinitis/conjunctivitis, or atopic dermatitis (Volunteers with a history of a common minor illness who have required intermittent use of therapeutic or prophylactic medications for less than or equal to 6 months in the last 5 years or for more than 6 months but more than 5 years ago are eligible).
• Other conditions that in the opinion of the investigator would jeopardize the safety of the subject or the evaluation of the study objectives.
• Any current illness requiring daily medication (other than vitamins, contraceptives, topical medications, antihistamines, antacids and other reflux medications, smoking cessation medications, headache medications that do not have antipyretic activity, nasal allergy medications, ophthalmologic and otic medications, and thyroxine for stable, inactive hypothyroidism). Volunteers may not take daily oral, nasal, inhaled, or parenteral steroids or non-steroidal anti-inflammatory medications. Medications other than those mentioned above will require approval from the PI, the sponsor, and the medical monitor.
• Abnormal physical findings including, but not limited to, the following:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Duke Children's Primary Care

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Replication Protein A

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Completion: May 1, 2007
• Last Updated: August 27, 2010

Record last verified: 2005-12

Locations

US (2)