PMID- 35958596 OWN - NLM STAT- MEDLINE DCOM- 20220815 LR - 20220817 IS - 1664-3224 (Electronic) IS - 1664-3224 (Linking) VI - 13 DP - 2022 TI - Immunogenicity and safety of concomitant administration of the chinese inactivated poliovirus vaccine with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine in children: A multicenter, randomized, non-inferiority, controlled trial. PG - 905634 LID - 10.3389/fimmu.2022.905634 [doi] LID - 905634 AB - KEY POINT: Considering that vaccination with the sIPV and DTaP overlap at the ages of 3 and 4 months in China, to reduce the burden of treatment on parents and increase vaccination coverage rates, we designed a postmarket clinical study of co-administration. BACKGROUND: The Sabin-strain-based inactivated poliovirus vaccine (sIPV) and the diphtheria-tetanus-acellular pertussis vaccine (DTaP) have been licensed in China for many years. To conduct a clinical study on the safety and immunogenicity of the sIPV when administered concomitantly with the DTaP. METHODS: The study population was divided into three groups: group 1 was the sIPV+ DTaP concomitant administration group, group 2 was the sIPV inoculation group, and group 3 was the DTaP inoculation group. Blood samples were collected prevaccination and 30 days postvaccination, and serum antibody levels were detected. RESULTS: This study showed that the seropositive and seroconversion rates of type 1, 2 and 3 poliovirus in group 1 were higher than those in group 2, with no statistically significant difference after vaccination (P>0.05). Groups 1 and 3 also showed similar responses for all vaccine antigens except anti-FHA (97.65 (94.09-99.36) vs. 100 (97.89-100)). The geometric mean titers (GMTs) for the DTaP and sIPV among the groups were comparable, and the non-inferiority t test result was P<0.001. The number of local adverse events (AEs) reported in group 1 (29.91%) were larger than those in group 2 (12.39%) and group 3 (21.93%), among which the most common was redness. Similarly, the most common systemic AE was fever. All 5 severe AE (SAE) cases were determined by experts to be unrelated to the vaccines during the study. CONCLUSIONS: The evidence of similar seroconversion and safety with co-administered DTaP and sIPV supports the co-administration supports the introduction of a strategy of simultaneous administration of both vaccines into routine infant immunization, and it could increase vaccination coverage and protect more infants from morbidity and mortality from these related diseases. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT04054882?term=NCT04054882&cntry=CN&draw=2&rank=1, identifier NCT04054882. CI - Copyright (c) 2022 Sun, Xu, Tang, Xiao, Wang, Wang, Zhu, Yang and Chen. FAU - Sun, Xiang AU - Sun X AD - Expanded Program on Immunization, Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu, China. FAU - Xu, Yan AU - Xu Y AD - Expanded Program on Immunization, Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu, China. FAU - Tang, Fenyang AU - Tang F AD - Expanded Program on Immunization, Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu, China. FAU - Xiao, Yanhui AU - Xiao Y AD - Medical Affairs, China National Biotec Group Company Limited, Beijing, China. FAU - Wang, Zhiguo AU - Wang Z AD - Expanded Program on Immunization, Jiangsu Provincial Center for Disease Control and Prevention, Jiangsu, China. FAU - Wang, Binbing AU - Wang B AD - Expanded Program on Immunization, Anhui Provincial Center for Disease Control and Prevention, Anhui, China. FAU - Zhu, Xiaoping AU - Zhu X AD - Expanded Program on Immunization, Sichuan Provincial Center for Disease Control and Prevention, Sichuan, China. FAU - Yang, Xiaoming AU - Yang X AD - Medical Affairs, China National Biotec Group Company Limited, Beijing, China. FAU - Chen, Haiping AU - Chen H AD - Medical Affairs, China National Biotec Group Company Limited, Beijing, China. LA - eng SI - ClinicalTrials.gov/NCT04054882 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20220726 PL - Switzerland TA - Front Immunol JT - Frontiers in immunology JID - 101560960 RN - 0 (Antibodies, Bacterial) RN - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines) RN - 0 (Poliovirus Vaccine, Inactivated) RN - 0 (Poliovirus Vaccine, Oral) RN - 0 (Vaccines, Combined) SB - IM MH - Antibodies, Bacterial MH - Child MH - *Diphtheria/prevention & control MH - *Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects MH - Humans MH - Infant MH - *Poliomyelitis/prevention & control MH - Poliovirus MH - *Poliovirus Vaccine, Inactivated/adverse effects MH - Poliovirus Vaccine, Oral MH - *Tetanus/prevention & control MH - Vaccines, Combined MH - *Whooping Cough/prevention & control PMC - PMC9361845 OTO - NOTNLM OT - DTaP OT - concomitant administration OT - immunogenicity OT - sIPV OT - safety OT - vaccine interference COIS- YH X, HC and XY are employees of China National Biotec Group Company Limited. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/08/13 06:00 MHDA- 2022/08/16 06:00 PMCR- 2022/01/01 CRDT- 2022/08/12 03:00 PHST- 2022/03/27 00:00 [received] PHST- 2022/06/27 00:00 [accepted] PHST- 2022/08/12 03:00 [entrez] PHST- 2022/08/13 06:00 [pubmed] PHST- 2022/08/16 06:00 [medline] PHST- 2022/01/01 00:00 [pmc-release] AID - 10.3389/fimmu.2022.905634 [doi] PST - epublish SO - Front Immunol. 2022 Jul 26;13:905634. doi: 10.3389/fimmu.2022.905634. eCollection 2022.