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Hum Vaccin. 2007 Sep-Oct;3(5):205-11. Epub 2007 May 18.

Safety, reactogenicity and immunogenicity of a recombinant protective antigen anthrax vaccine given to healthy adults.

Author information

  • 1University of Maryland School of Medicine, Center for Vaccine Development, Baltimore, Maryland 21201, USA. jcampbel@medicine.umaryland.edu

Abstract

BACKGROUND:

Bacillus anthracis causes anthrax, a vaccine-preventable zoonotic disease that may follow intentional or unintentional exposure to its spores. Although an anthrax vaccine is currently licensed in the USA, better vaccines are desirable for both pre- and post-exposure prophylaxis.

METHODS:

Healthy adults, aged 18-40 years, received anthrax immunization with either licensed Anthrax Vaccine Adsorbed (AVA, BioThrax), or an experimental recombinant Protective Antigen vaccine (rPA) produced from an avirulent, non-spore-forming strain of B. anthracis at one of four doses (5, 25, 50 or 75 microg). Volunteers were followed for safety, reactogenicity, and immunogenicity.

RESULTS:

rPA vaccine was well tolerated with a low rate of local or systemic reactions. Although antibody responses were poor following unadjuvanted rPA administration, 89 and 100% of volunteers who received Alhydrogel-adjuvanted rPA given intramuscularly had four-fold increases by enzyme-linked immunosorbent and toxin neutralization assays, respectively. Peak antibody responses to adjuvanted rPA given intramuscularly were equivalent to AVA, given either intramuscularly or subcutaneously, when measured by either assay.

CONCLUSIONS:

This recombinant Protective Antigen anthrax vaccine, when given with the adjuvant Alhydrogel to healthy adults in two intramuscular injections four weeks apart, is very well-tolerated and highly immunogenic.

PMID:
17881903
[PubMed - indexed for MEDLINE]
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