Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Issue 12 (14th March 2016)

• Record Type: Journal Article
• Authors: Li, Rongcheng; Li, Chang Gui; Li, Yanping; Liu, Youping; Zhao, Hong; Chen, Xiaoling; Kuriyakose, Sherine; Van Der Meeren, Olivier; Hardt, Karin; Hezareh, Marjan; Roy-Ghanta, Sumita
• Is Part Of: Vaccine. Volume 34:Issue 12(2016)
• Page Start: 1436
• Page End: 1443
• Publication Date: 2016-03-14
• Subjects: Poliomyelitis -- Poliovirus -- Vaccine -- Oral poliovirus vaccine -- Inactivated poliovirus vaccine -- Booster -- China -- Eradication; CCID50 median cell culture infective dose -- CI confidence interval -- D Dalton units -- DTP diphtheria-tetanus-pertussis vaccine -- DTPa/Hib combined diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b conjugate vaccine -- GMT geometric mean titres -- Hib Haemophilus influenzae type b -- IPV inactivated poliovirus vaccines -- OPV oral live-attenuated oral poliovirus vaccines -- SAE serious adverse event -- VAPP vaccine associated paralytic poliomyelitis -- WHO World Health Organization; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2016.02.010
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: IPV safety and immunogenicity were assessed in the Chinese vaccination schedule. IPV was non-inferior to Chinese OPV in terms of seroprotection rates. IPV had a clinically acceptable safety profile in four studies. IPV could feasibly be incorporated into Chinese vaccination schedule. Abstract: Introduction: Replacing live-attenuated oral poliovirus vaccines (OPV) with inactivated poliovirus vaccines (IPV) is part of the global strategy to eradicate poliomyelitis. China was declared polio-free in 2000 but continues to record cases of vaccine-associated-poliomyelitis and vaccine-derived-poliovirus outbreaks. Two pilot safety studies and two larger immunogenicity trials evaluated the non-inferiority of IPV ( Poliorix ™, GSK Vaccines, Belgium) versus OPV in infants and booster vaccination in toddlers primed with either IPV or OPV in China. Methods: In pilot safety studies, 25 infants received 3-dose IPV primary vaccination (Study A, www.clinicaltrial.gov NCT00937404 ) and 25 received an IPV booster after priming with three OPV doses (Study B, NCT01021293 ). In the randomised, controlled immunogenicity and safety trial (Study C, NCT00920439 ), infants received 3-dose primary vaccination with IPV ( N = 541) or OPV ( N = 535) at 2, 3, 4 months of age, and a booster IPV dose at 18-24 months ( N = 470, Study D, NCT01323647 : extension of study C). Blood samples were collected before and one month post-dose-3 and booster. Reactogenicity was assessed using diary cards. Serious adverse events (SAEs) were captured throughout each study. Results: Study A and B showed that IPV priming and IPV boosting (after OPV) was safe. Study C: One month post-dose-3, all IPV and ≥98.3% OPV recipients had seroprotective antibody titres towards each poliovirus type. The immune response elicited by IPV was non-inferior to Chinese OPV. Seroprotective antibody titres persisted in ≥94.7% IPV and ≥96.1% OPV recipients at 18–24 months (Study D). IPV had a clinically acceptable safety profile in all studies. Grade 3 local and systemic reactions were uncommon. No SAEs were related to IPV administration. Conclusion: Trivalent IPV is non-inferior to OPV in terms of seroprotection (in the Chinese vaccination schedule) in infant and toddlers, with a clinically acceptable safety profile.