Safety, Immunogenicity and Lot-to-Lot Consistency of Sabin-Strain Inactivated Poliovirus Vaccine in 2-Month-Old Infants: A Double-Blind, Randomized Phase III Trial

被引:4
|
作者
Zheng, Yan [1 ]
Ying, Zhifang [2 ]
Zou, Yanxiang [1 ]
Zhu, Taotao [3 ]
Qian, Dinggu [4 ]
Han, Weixiao [3 ]
Jiang, Ya [5 ]
Jiang, Zhiwei [6 ]
Li, Xingyan [7 ]
Wang, Jianfeng [3 ]
Lei, Jin [8 ]
Xu, Li [9 ]
Jiang, Deyu [10 ]
Li, Changgui [2 ]
Liu, Xiaoqiang [1 ]
机构
[1] Vaccine Clin Res Ctr, Yunnan Prov Ctr Dis Control & Prevent, Kunming, Peoples R China
[2] Natl Inst Food & Drug Control, Biol Prod Inst, Resp Virus Vaccine Dept, Beijing 100050, Peoples R China
[3] Sinovac Biotech Co Ltd, Dept Clin Res, Beijing 100089, Peoples R China
[4] Qiubei Cty Ctr Dis Control & Prevent, Vaccine Clin Res Proj Off, Wenshan Zhuang & Miao Autonomous Prefecture, Beijing 663299, Peoples R China
[5] Mile Cty Ctr Dis Control & Prevent, Vaccine Clin Res Project Off, Honghe Hani & Yi Autonomous Prefecture, Beijing 652399, Peoples R China
[6] Beijing Key Tech Stat Consulting Co Ltd, Dept Stat, Beijing 100025, Peoples R China
[7] Yanshan Cty Ctr Dis Control & Prevent, Div Acute Infect Dis Control & Prevent, Wenshan Zhuang & Miao Autonomous Prefecture, Beijing 663299, Peoples R China
[8] Gejiu Cty Ctr Dis Control & Prevent, Immunizat Program Div, Honghe Hani & Yi Autonomous Prefecture, Beijing 661099, Peoples R China
[9] Sinovac Biotech Co Ltd, Qual Assurance Dept, Beijing 100089, Peoples R China
[10] Sinovac Life Sci Co Ltd, R&D Dept, Beijing 102629, Peoples R China
关键词
Sabin strain; inactivated poliovirus vaccine; lot-to-lot consistency; safety; immunogenicity; IPV;
D O I
10.3390/vaccines10020254
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background: The Sabin-strain-based inactivated poliovirus vaccine (sIPV) plays an important role in poliomyelitis eradication in developing countries. As part of the phase III clinical development program, this study aimed to evaluate the safety, immunogenicity and lot-to-lot consistency of the sIPV in 2-month-old infants. Method: We conducted a phase III, randomized, double-blind, positive-controlled trial in which 1300 healthy infants were randomly assigned to four groups in a 1:1:1:1 ratio to receive one of the three lots of the sIPV or the control IPV at 2, 3 and 4 months of age. Serum samples were collected before the first dose and 30 days after the third dose of vaccination to assess the immunogenicity. Solicited local and systemic reactions were recorded within 7 days and unsolicited adverse events within 30 days after each vaccination. Results: Of the 1300 randomized infants, 1190 infants completed the study and were included in the per-protocol population. The seroconversion rates in the three lots of the sIPV were 95.67%, 97.03% and 95.59%, respectively, for type 1; 94.33%, 93.73% and 92.88%, respectively, for type 2; and 98.67%, 99.67% and 99.32%, respectively, for type 3. The ratios of GMTs for poliovirus types 1, 2 and 3 of each pair of lots were all between 0.67 and 1.50, therefore meeting the predefined immunological equivalence criteria. For the seroconversion rate of poliovirus types 1, 2 and 3, the pooled sIPV group was non-inferior to the IPV group. The incidence of solicited and unsolicited adverse reactions (ARs) was similar in the pooled sIPV lots and the IPV group, and most of them were mild to moderate in severity. Non-vaccine-related serious adverse events (SAEs) were reported. Conclusions: Three consecutive lots of sIPV demonstrated robust and consistent immunogenicity. The safety and tolerability of the sIPV was acceptable and similar to that of the IPV.
引用
收藏
页数:10
相关论文
共 50 条
  • [21] Safety and Immunogenicity of Inactivated Poliovirus Vaccine Made From Sabin Strains: A Phase II, Randomized, Positive-Controlled Trial
    Liao, Guoyang
    Li, Rongcheng
    Li, Changgui
    Sun, Mingbo
    Li, Yanping
    Chu, Jiayou
    Jiang, Shude
    Li, Qihan
    JOURNAL OF INFECTIOUS DISEASES, 2012, 205 (02): : 237 - 243
  • [22] A phase II, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine
    Tang, Rong
    Li, Guifan
    Zhang, Chengfu
    Zhi, Hengkui
    Zhu, Jiahong
    Wang, Jianjun
    Liang, Qi
    Hu, Yuemei
    Li, Changgui
    HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2020, 16 (11) : 2641 - 2648
  • [23] Safety and Immunogenicity of Trivalent Inactivated Influenza Vaccine in Infants A Randomized Double-Blind Placebo-Controlled Study
    Englund, Janet A.
    Walter, Emmanuel
    Black, Steven
    Blatter, Mark
    Nyberg, Jack
    Ruben, Frederick L.
    Decker, Michael D.
    PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2010, 29 (02) : 105 - 110
  • [24] A randomized, double-blinded Phase 3 study to demonstrate lot-to-lot consistency and to confirm immunogenicity and safety of the live-attenuated chikungunya virus vaccine candidate VLA1553 in healthy adults
    Mcmahon, Robert
    Fuchs, Ulrike
    Schneider, Martina
    Hadl, Sandra
    Hochreiter, Romana
    Bitzer, Annegret
    Kosulin, Karin
    Koren, Michael
    Mader, Robert
    Zoihsl, Oliver
    Wressnigg, Nina
    Dubischar, Katrin
    Buerger, Vera
    Eder-Lingelbach, Susanne
    Jaramillo, Juan Carlos
    JOURNAL OF TRAVEL MEDICINE, 2024, 31 (02)
  • [25] Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults
    Halperin, Scott A.
    Das, Rituparna
    Onorato, Matthew T.
    Liu, Kenneth
    Martin, Jason
    Grant-Klein, Rebecca J.
    Nichols, Rick
    Coller, Beth-Ann
    Helmond, Frans A.
    Simon, Jakub K.
    JOURNAL OF INFECTIOUS DISEASES, 2019, 220 (07): : 1127 - 1135
  • [26] A Randomized Phase 4 Study of Immunogenicity and Safety After Monovalent Oral Type 2 Sabin Poliovirus Vaccine Challenge in Children Vaccinated with Inactivated Poliovirus Vaccine in Lithuania
    Bandyopadhyay, Ananda S.
    Gast, Chris
    Brickley, Elizabeth B.
    Ruttimann, Ricardo
    Clemens, Ralf
    Oberste, M. Steven
    Weldon, William C.
    Ackerman, Margaret E.
    Connor, Ruth, I
    Wieland-Alter, Wendy F.
    Wright, Peter
    Usonis, Vytautas
    JOURNAL OF INFECTIOUS DISEASES, 2021, 223 (01): : 119 - 127
  • [27] Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study
    Capeding, Maria Rosario
    Gomez-Go, Grace Devota
    Oberdorfer, Peninnah
    Borja-Tabora, Charissa
    Bravo, Lulu
    Carlos, Josefina
    Tangsathapornpong, Auchara
    Uppala, Rattapon
    Laoprasopwattana, Kamolwish
    Yang, Yunjeong
    Han, Song
    Wittawatmongkol, Orasri
    JOURNAL OF INFECTIOUS DISEASES, 2022, 226 (02): : 308 - 318
  • [28] Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged >50 years: A randomized phase 3 trial (PNEU-TRUE)
    Simon, Jakub K.
    Staerke, Nina Breinholt
    Hemming-Harlo, Maria
    Layle, Stacey
    Dagan, Ron
    Shekar, Tulin
    Pedley, Alison
    Jumes, Patricia
    Tamms, Gretchen
    Sterling, Tina
    Musey, Luwy
    Buchwald, Ulrike K.
    VACCINE, 2022, 40 (09) : 1342 - 1351
  • [29] Immunogenicity, safety and consistency of seven lots of an inactivated COVID-19 vaccine in healthy children and adolescents: a randomized, double-blind, controlled, phase IV clinical trial
    Hu, Weijun
    Liu, Xiaoyu
    Lu, Xi
    Zhang, Dan
    Liu, Shuo
    Gu, Xianjin
    Liu, Dan
    Sun, Jianwen
    Zhou, Tiantian
    Li, Xinge
    Gao, Yongjun
    Zhao, Yanwei
    Cui, Guoliang
    Zhang, Shaobai
    FRONTIERS IN IMMUNOLOGY, 2024, 14
  • [30] Safety and immunogenicity of a modified Omicron-adapted inactivated vaccine in healthy adults: a randomized, double-blind, active-controlled Phase III clinical trial
    Hu, Jialei
    Liu, Yueyue
    Liu, Shuo
    Shu, Qun
    Yang, Xuenan
    Chu, Kai
    Qiao, Yaping
    Hu, Yaling
    Wang, Kaiqin
    Pan, Hongxing
    FRONTIERS IN IMMUNOLOGY, 2023, 14