Journal Article

Gorse GJ, et al. “Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: A randomized, double-blinded, controlled, multicenter trial” Vaccine 24 (2006) 5950–5959

Zink, Thomas K.

2007

Overview

In the study reported by Gorse et al. a unique, educational opportunity was lost. The vaccine and biodefense communities almost experienced the rare chance in a Phase I study to scientifically compare head-to-head an early-stage, investigational recombinant anthrax vaccine (rPA102) with the safe, effective and already FDA-licensed anthrax vaccine, AVA (BioThrax ®). The authors take a stab at making safety and immunogenicity comparisons between the candidate vaccine and AVA (BioThrax ®) but the study design and analytical approach makes this inappropriate. Inaccurate and poorly substantiated editorial comments in the paper's introduction compound these methodological problems. The reader is presented with a series of false and misleading statements about AVA (BioThrax ®). Out-of-date sources are relied upon and these references are offered to the reader as the best evidence available when more current papers with up-to-date information and data exist. Additionally, the conclusions in several original contributions are misrepresented in this paper by Gorse et al. Issues with protocol and bias notwithstanding, the single most compelling observation from this trial could be that the response of those subjects in this study population ( n = 19) who received AVA on the altered schedule and route of two doses of AVA (BioThrax ®) delivered intramuscularly (IM) in just 4 weeks mounted a robust immune response. Given the more than 30 year history of the safe and effective use of AVA (BioThrax ®) as well as the more current data on AVA (BioThrax ®) a strong case can be made for continued funding to investigate the feasibility of adding another route of delivery (IM) and optimizing the schedule for this already FDA-licensed vaccine.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Allergy and Immunology / Anthrax / Anthrax Vaccines - administration & dosage / Anthrax Vaccines - adverse effects / Anthrax Vaccines - immunology / Biothrax / Humans / Immune response / Immunogenicity / Licenses / Medical research / Randomized Controlled Trials as Topic - methods / Reactogenicity / Recombinant protective antigen / Research Design / Safety / Vaccine / Vaccines / Vaccines, Synthetic - administration & dosage / Vaccines, Synthetic - adverse effects / Vaccines, Synthetic - immunology