Scientific Publications by FDA Staff

J Infect Dis 2006 Sep 15;194(6):804-7

Further development of a new transgenic mouse test for the evaluation of the immunogenicity and protective properties of inactivated poliovirus vaccine.

Dragunsky EM, Ivanov AP, Abe S, Potapova SG, Enterline JC, Hashizume S, Chumakov KM

Dragunsky EM, HFM-470,NLRC B-121,1401 Rockville Pike, Rockville, MD 20852 USA US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20857 USA Poliomyelitis Res Inst, Tokyo, Japan

Recently, we developed and optimized a new method for the evaluation of the protective properties of serotype 2 inactivated poliovirus vaccines (IPV). The method is based on the immunization and subsequent challenge of transgenic (Tg) mice susceptible to poliovirus. We describe a similar method for the assessment of the protectiveness of serotype 1 IPV and demonstrate that experimental IPV produced from attenuated Sabin strain (sIPV) of serotype 1 poliovirus induced serum neutralizing antibodies, immunoglobulin (Ig) G, IgM, and salivary IgA at titers comparable to those induced by conventional IPV (cIPV) produced from the wild-type Mahoney strain. In contrast to our previous results with serotype 2 sIPV, serotype 1 sIPV provided even better protection of Tg mice than cIPV against challenge with wild-type Mahoney strain.