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Scott T. Rottinghaus, Gregory A. Poland, The First Antibody Responses to DNA Vaccines in Humans, The Journal of Infectious Diseases, Volume 197, Issue 11, 1 June 2008, Page 1628, https://doi.org/10.1086/587944
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To the Editor—In their recent article, Martin et al. [1] report an important phase 1 clinical trial of a DNA vaccine for West Nile Virus. They conclude that “[t]his clinical study represents the first report of neutralizing antibody activity elicited by a DNA vaccine in humans” [1, p. 1739]; the accompanying editorial commentary, by Peterson and Roehrig, repeats this claim [2, p. 1722]. Although Martin et al. elegantly demonstrate neutralizing-antibody responses by using plaque-reduction neutralization and reporter-virus particles, multiple earlier clinical trials demonstrating putative neutralizing-antibody responses have been reported.
To our knowledge, the first report of a protective antibody response induced by a DNA vaccine was published in 2000 by Roy et al. [3]. DNA encoding the surface antigen of hepatitis B virus (HBV) was administered to 12 healthy, hepatitis-naive human volunteers via particle-mediated epidermal delivery (PMED). All volunteers developed protective antibody responses, defined as ⩾10 mIU/mL. This level of antibody response against HBV has long been considered sufficient to protect against HBV infection [4]. Subsequent studies confirmed that this HBV DNA vaccine could elicit antibody responses in those who do not respond to conventional vaccine [5] and could increase antibody titers when administered via a disposable, commercial prototype device [6].