Safety and Immunogenicity of Inactivated Poliovirus Vaccine Made From Sabin Strains: A Phase II, Randomized, Positive-Controlled Trial

Abstract

NCT01056705.

Immunogenicity and safety evaluation of bivalent types 1 and 3 oral poliovirus vaccine by comparing different poliomyelitis vaccination schedules in China: A randomized controlled non-inferiority clinical trial

“…In a comparison study among Chinese population, the GMT after vaccinated by cIPV was 386 (297-502), while the GMT after vaccine with tOPV was 3315 (2703-4064). 24 Compared with I-I-B, I-B-B possessed a significantly higher PV1 reciprocal titer, while the PV3 reciprocal antibody titer in I-I-B was higher than in the I-B-B group. In the context of the final stage of polio eradication, PV2 immunity is of concern as well.…”

Antibody responses of Macaca fascicularis against a new inactivated polio vaccine derived from Sabin strains (sIPV) in DTaP-sIPV vaccine

“…Recently, the phase II clinical trial of sIPV was conducted in China [15]. It was reported that the appropriate concentrations of sIPV were 15 DU, 32 DU, and 45 DU for types 1, 2, and 3, respectively.…”

Development and introduction of inactivated poliovirus vaccines derived from Sabin strains in Japan

“…To mention one, clinical studies of IPV-containing vaccines have been conducted by subcutaneous administration as the standard method in Japan, and accordingly, the vaccines are subcutaneously administered by routine immunization. However, clinical studies of sIPV in other counties were conducted by intramuscular injection [80][81][82][83]. It is difficult to compare the safety and efficiency among different sIPV-containing vaccines in Japan and other countries because of the difference in the immunization routes of sIPV.…”

“…sIPV would be one of the most attractive and readily available options to be able to manufacture IPV at safer production facilities in middle-and low-income countries. At present, in addition to the three DTaP-sIPV manufacturers in Japan (Kaketsuken, Biken, and Takeda), sIPV has been independently developed by two other institutes, Intravacc (formerly part of the National Institute for Public Health and the Environment and Netherlands Vaccine Institute) and the Chinese Academy of Medical Sciences in Kunming, China (Kunming Institute), and both of which have started preclinical and clinical studies on sIPV [81][82][83][95][96][97][98][99][100] (Table 3).…”

“…Based on the national sIPV references, Kaketsuken and Biken conducted Phase II dose-finding clinical studies and both of them selected the D-antigen contents of 1.5, 50, and 50 sDU/dose for poliovirus types 1, 2, and 3, respectively [58,59] ( Table 3). According to the results in a Phase II clinical study of standalone sIPV in China, the Kunming Institute group has selected the D-antigen contents of 15, 32, and 45 sDU/dose for types 1, 2, and 3, respectively (see comments below regarding the difficulties in comparing sDU values from different laboratories) as optimal doses [83]. In a rat immunogenicity test, the Intravacc group opted for D-antigen contents of 10, 16, and 32 sDU/dose for sIPV types 1, 2, and 3, respectively [53,99].…”