Anthrax-rPA: Safety, Tolerability, Immunogenicity

NCT00063843 | Completed Phase 1

• 2 other identifiers: 01-003Anthrax CVD 1000
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the tolerability and safety, from days 0 to 210, of escalating doses of rPA either with or without Alhydrogel (an adjuvant; used to increase the action of the principle drug) given in a two-dose, intramuscular regimen to health adults. The secondary objective is to evaluate antibody responses to rPA, from days 0 to 210, following one of four escalating doses of vaccine given with and without Alhydrogel given in a two-dose series to healthy adults, and to compare immune responses following rPA with those following BioThrax (tm) given by either the intramuscular or SQ route. The tertiary objective is to describe the antibody kinetics following vaccination. This information will be used to determine the most probable optimal dose of rPA and/or Alhydrogel that is safe, well tolerated, and maximally immunogenic for use in future phase II trials.

Conditions

Anthrax

Keywords

Bacillus anthracis (anthrax)

Interventions

Recombinant Protective Antigen, Anthrax Vaccine Adsorbed BIOLOGICAL

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 40 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: screening, HIV antibody testing, stored specimen, HIPAA authorization, and protocol-specific consents. 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 tubal ligation, implants, injectables, combined oral contraceptives, some IUD's (All commonly used copper and hormone implanted IUD's in the US are highly effective including the following types: TCu-380A, TCu-220C, MLCu-375, Nova-T, and LNG-20. The less effective IUD's include the Lippes loop and the stainless steel ring), sexual abstinence, and a vasectomized partner. Agreement to refrain from taking any experimental drug or vaccine from day -30 to day 90.

Sponsors & Collaborators

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

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Anthrax Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 7, 2003
• First Posted: July 8, 2003
• Study Start: July 1, 2003
• Study Completion: August 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2006-05

Locations

US (1)