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NEW THIS SATURDAY: SAFETY AND IMMUNOGENICITY OF INACTIVATED POLIOVIRUS VACCINE MADE FROM SABIN STRAINS

Friday, 30th of August 2013

• SAFETY AND IMMUNOGENICITY OF INACTIVATED POLIOVIRUS VACCINE MADE FROM SABIN STRAINS: A PHASE II, RANDOMIZED, POSITIVE-CONTROLLED TRIAL

J Infect Dis. 2012 Jan 15;205(2):237-43. doi: 10.1093/infdis/jir723. Epub 2011 Dec 8.

Liao G, Li R, Li C, Sun M, Li Y, Chu J, Jiang S, Li Q.

Source

Institute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.

Abstract below; full text is at http://jid.oxfordjournals.org/content/205/2/237.long

BACKGROUND:

The production of Sabin inactivated poliovirus vaccine (IPV) can reduce biosafety requirements in the posteradication/post-oral poliovirus vaccine (OPV) era. We conducted a phase II, randomized, positive-controlled trial to assess the safety and immunogenicity of Sabin IPV.

METHODS:

The test groups (A, B, and C) received 3 doses of high, middle, and low D antigen (D Ag) of Sabin IPV at ages 2, 3, and 4 months, respectively. Infants in 2 control groups, group D and group E, received 3 doses of trivalent OPV and conventional IPV (cIPV), respectively, on the same schedule as that of groups A, B, and C. Serum samples were collected before and 30 days after the administration of the third dose.

RESULTS:

In total, 500 infants were randomly assigned to 5 groups, and 449 infants completed the vaccine series. No serious adverse events were associated with vaccinations. After 3 doses, the seroconversion rates in groups A, B, C, D, and E were 100%, 97.8%, 96.6%, 100%, and 90.1%, respectively, for type 1 poliovirus; 97.7%, 95.7%, 78.7%, 100%, and 90.1%, respectively, for type 2; and 98.8%, 98.9%, 93.3%, 100%, and 97.8%, respectively, for type 3.

CONCLUSIONS:

Sabin IPV has good safety characteristics. The seroconversion rates for type 1 poliovirus (most appropriate concentration, 15 D Ag units [DU]), type 2 (32 DU), and type 3 (45 DU) Sabin IPV were similar to those of the OPV and cIPV control groups. Clinical Trials Registration: NCT01056705.

Comment in

The final phase of polio eradication: new vaccines and complex choices. [J Infect Dis. 2012]

The final phase of polio eradication: new vaccines and complex choices.Cochi SL, Linkins RW. J Infect Dis. 2012 Jan 15; 205(2):169-71. Epub 2011 Dec 8.