Evaluation of the safety, immunogenicity, and faecal shedding of novel oral polio vaccine type 2 in healthy newborn infants in Bangladesh: a randomised, controlled, phase 2 clinical trial.

Autor:	Zaman K; International Centre for Diarrhoeal Disease Research, Chandpur, Bangladesh., Bandyopadhyay AS; Bill & Melinda Gates Foundation, Seattle, WA, USA. Electronic address: ananda.bandyopadhyay@gatesfoundation.org., Hoque M; International Centre for Diarrhoeal Disease Research, Chandpur, Bangladesh., Gast C; PATH, Seattle, WA, USA., Yunus M; International Centre for Diarrhoeal Disease Research, Chandpur, Bangladesh., Jamil KM; National Polio and Measles Laboratory, Institute of Public Health, Dhaka, Bangladesh., Mainou BA; US Centers for Disease Control and Prevention, Atlanta, GA, USA., Konopka-Anstadt JL; PATH, Seattle, WA, USA., Hendley WS; US Centers for Disease Control and Prevention, Atlanta, GA, USA., Vincent A; US Centers for Disease Control and Prevention, Atlanta, GA, USA., Clemens R; Global Research in Infectious Diseases, Rio de Janeiro, Brazil., Clemens SAC; Global Research in Infectious Diseases, Rio de Janeiro, Brazil; Department of Paediatrics, Oxford University, Oxford, UK., Ross AG; International Centre for Diarrhoeal Disease Research, Chandpur, Bangladesh; Rural Health Research Institute, Charles Sturt University, Wagga Wagga, NSW, Australia., Clemens JD; International Centre for Diarrhoeal Disease Research, Chandpur, Bangladesh; International Vaccine Institute, Seoul, South Korea., Tritama E; PT Bio Farma, Bandung, Indonesia.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2023 Jan 14; Vol. 401 (10371), pp. 131-139. Date of Electronic Publication: 2022 Dec 07.
DOI:	10.1016/S0140-6736(22)02397-2
Abstrakt:	Background: Type 2 circulating vaccine-derived polioviruses (cVDPV2) from Sabin oral poliovirus vaccines (OPVs) are the leading cause of poliomyelitis. A novel type 2 OPV (nOPV2) has been developed to be more genetically stable with similar tolerability and immunogenicity to that of Sabin type 2 vaccines to mitigate the risk of cVDPV2. We aimed to assess these aspects of nOPV2 in poliovirus vaccine-naive newborn infants. Methods: In this randomised, double-blind, controlled, phase 2 trial we enrolled newborn infants at the Matlab Health Research Centre, Chandpur, Bangladesh. We included infants who were healthy and were a single birth after at least 37 weeks' gestation. Infants were randomly assigned (2:1) to receive either two doses of nOPV2 or placebo, administered at age 0-3 days and at 4 weeks. Exclusion criteria included receipt of rotavirus or any other poliovirus vaccine, any infection or illness at the time of enrolment (vomiting, diarrhoea, or intolerance to liquids), diagnosis or suspicion of any immunodeficiency disorder in the infant or a close family member, or any contraindication for venipuncture. The primary safety outcome was safety and tolerability after one and two doses of nOPV2, given 4 weeks apart in poliovirus vaccine-naive newborn infants and the primary immunogenicity outcome was the seroconversion rate for neutralising antibodies against type 2 poliovirus, measured 28 days after the first and second vaccinations with nOPV2. Study staff recorded solicited and unsolicited adverse events after each dose during daily home visits for 7 days. Poliovirus neutralising antibody responses were measured in sera drawn at birth and at age 4 weeks and 8 weeks. This study is registered on ClinicalTrials.gov, NCT04693286. Findings: Between Sept 21, 2020, and Aug 16, 2021, we screened 334 newborn infants, of whom three (<1%) were found to be ineligible and one (<1%) was withdrawn by the parents; the remaining 330 (99%) infants were assigned to receive nOPV2 (n=220 [67%]) or placebo (n=110 [33%]). nOPV2 was well tolerated; 154 (70%) of 220 newborn infants in the nOPV2 group and 78 (71%) of 110 in the placebo group had solicited adverse events, which were all mild or moderate in severity. Severe unsolicited adverse events in 11 (5%) vaccine recipients and five (5%) placebo recipients were considered unrelated to vaccination. 306 (93%) of 330 infants had seroprotective maternal antibodies against type 2 poliovirus at birth, decreasing to 58 (56%) of 104 in the placebo group at 8 weeks. In the nOPV2 group 196 (90%) of 217 infants seroconverted by week 8 after two doses, when 214 (99%) had seroprotective antibodies. Interpretation: nOPV2 was well tolerated and immunogenic in newborn infants, with two doses, at birth and 4 weeks, resulting in almost 99% of infants having protective neutralising antibodies. Funding: Bill & Melinda Gates Foundation. Competing Interests: Declaration of interests ET is a full-time employee of the vaccine manufacturer, PT Bio Farma (Bandung, Indonesia). All other authors declare no competing interests. (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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