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ABSTRACT
Background: The type 2 component of the oral poliovirus vaccine is targeted for global withdrawal through a switch from the trivalent oral poliovirus vaccine (tOPV) to a bivalent oral poliovirus vaccine (bOPV). The switch is intended to prevent paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess the immunogenicity and safety profile of 6 vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.
Methods: A randomized controlled trial was conducted in China in 2015. Healthy newborn babies randomly received one of the following 6 vaccination schedules: cIPV-bOPV-bOPV(I-B-B), cIPV-tOPV-tOPV(I-T-T), cIPV-cIPV-bOPV(I-I-B), cIPV-cIPV-tOPV(I-I-T), cIPV-cIPV-cIPV(I-I-I), or tOPV-tOPV-tOPV(T-T-T). Doses were administered sequentially at 4–6 week intervals after collecting baseline blood samples. Patients were proactively followed up for observation of adverse events after the first dose and 30 days after all doses. The primary study objective was to investigate the immunogenicity and safety profile of different vaccine schedules, evaluated by seroconversion, seroprotection and antibody titer against poliovirus types 1, 2, and 3 in the per-protocol population.
Results: Of 600 newborn babies enrolled, 504 (84.0%) were included in the per-protocol population. For type 1 poliovirus, the differences in the seroconversion were 1.17% (95% CI = −2.74%, 5.08%) between I-B-B and I-T-T and 0.00% (95% CI: −6.99%, 6.99%) between I-I-B and I-I-T; for type 3 poliovirus, differences in the seroconversion were 3.49% (95% CI: −1.50%, 8.48%) between I-B-B and I-T-T and −2.32% (95% CI: −5.51%, 0.86%) between I-I-B and I-I-T. The non-inferiority conclusion was achieved in both poliovirus type 1 and 3 with the margin of −10%. Of 24 serious adverse events reported, no one was vaccine-related.
Conclusions: The vaccination schedules with bOPV followed by one or 2 doses of IPV were recommended to substitute for vaccinations involving tOPV without compromising the immunogenicity and safety in the Chinese population. The findings will be essential for policy formulation by national and global authorities to facilitate polio elimination.
Abbreviations
| AEs | = | Adverse Events |
| bOPV | = | bivalent Oral Poliovirus Vaccine |
| cIPV | = | trivalent conventional Inactivated Poliovirus Vaccine |
| CDC | = | Center of Diseases Control and Prevention |
| cVDPV | = | circulating Vaccine-Derived Poliovirus |
| DTP | = | Diphtheria-Tetanus-Pertussis vaccine |
| GPEI | = | Global Polio Eradication Initiative |
| GMT | = | Geometric Mean of Reciprocal Antibody Titer |
| GMI | = | Fold Increase in GMT |
| IPV | = | Inactivate Poliovirus Vaccine |
| I-B-B | = | cIPV-bOPV-bOPV |
| I-T-T | = | cIPV-tOPV-tOPV |
| I-I-B | = | cIPV-cIPV-bOPV |
| I-I-T | = | cIPV-cIPV-tOPV |
| I-I-I | = | cIPV-cIPV-cIPV |
| OPV | = | Oral Poliovirus Vaccine |
| PP | = | Per-Protocol |
| PV1 | = | Type 1 Poliovirus |
| PV2 | = | Type 2 Poliovirus |
| PV3 | = | Type 3 Poliovirus |
| SAEs | = | Serious Adverse Events |
| T-T-T | = | tOPV-tOPV-tOPV |
| tOPV | = | trivalent Oral Poliovirus Vaccine |
| UNICEF | = | United Nations Children's Fund |
| WPV1 | = | Wild Type 1 Poliovirus |
| WHO | = | World Health Organization |
| 95% CIs | = | 95% Confidence Intervals |
Disclosure of potential conflicts of interest
The authors declare no conflicts of interests.
Acknowledgments
The findings and conclusions in this report are those of the authors and do not necessarily represent the views of Center of Disease Control and other contributing agencies. We sincerely thank all investigators and the families who participated in the study.
Funding
This work was supported by National Natural Science Foundation of China (Grant No. 81273176; 81473069), National Major Scientific and Technological Special Project for Significant New Drugs Development of China (Grant No. 2015ZX09501008–004), and Technological Special Project for Significant New Drugs Development of China (Grant No.2013ZX09402302–003).
Author contributions
Jingjun Qiu: drafted the manuscript and provided statistical analysis.
Yunkai Yang: trial design and coordinate trial conduction
Ling Wang: trial design and statistical analysis
Zhiwei Jiang: provided the main part of statistical analysis.
Wei Wang: trial conduction
Hongyan Wang: process optimization
Shaohong Guo: trial conduction
Chanjuan Li: trial design and statistical analysis
Prof. Jielai Xia: contributed to the study concept and design.
Dr. Zhaojun Mo: trial design, conduct and evaluation
Prof. Shuyuan Wei: contributed to the study concept and design
All authors contributed to the interpretation of data, final review and approval of the manuscript.