A Phase 1/2, Randomized, Observer-Blind, Active-Controlled, Age De-escalation, Dose Combination Ranging Study to Assess the Safety and Immunogenicity of Co-administered Novel Live Attenuated Trivalent Oral Poliomyelitis Vaccine in Healthy Adults, Young Children, and Neonates and Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines 1 and 2 in Neonates in Bangladesh

The main objectives of this study are to :
* evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines;
* evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control.
* compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates;
* evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.

Start Date10 Nov 2024

Sponsor / Collaborator

Program for Appropriate Technology in Health

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100 Clinical Results associated with Novel oral poliomyelitis vaccine type 1(nOPV1)(PATH)

100 Translational Medicine associated with Novel oral poliomyelitis vaccine type 1(nOPV1)(PATH)

100 Patents (Medical) associated with Novel oral poliomyelitis vaccine type 1(nOPV1)(PATH)

Literatures (Medical) associated with Novel oral poliomyelitis vaccine type 1(nOPV1)(PATH)

10 May 2019·Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi

[Observation on safety of sequential vaccination schedule of different strain inactivated poliovirus vaccines].

Article

Author: Wu, L L ; Li, Z ; Huang, Z Y ; Ren, J ; Sun, X D ; Liu, J C ; Hu, J Y ; Zhang, J N

Objective: To evaluate the safety of population based sequential vaccination schedule of inactivated poliovirus vaccines prepared with different strains. Methods: This randomized, parallel-group controlled trial was conducted from March, 2017 to May, 2018, in Shanghai. Adverse reaction data of Sabin strain inactivated polio vaccine (sIPV), wild strains inactivated polio vaccines (wIPV) and bivalent types Ⅰ and Ⅲ oral poliomyelitis vaccine (bOPV) were systematically collected through active observation in 1 917 infants in Shanghai after the vaccination at 2, 3, 4 months old. The eligible infants aged 2 months were divided into 4 groups: ①sIPV+sIPV+bOPV group; ②sIPV+wIPV+bOPV group; ③wIPV+sIPV+bOPV group; ④wIPV+wIPV+bOPV group. Results: The incidence of adverse reaction 30 days later after 3 basic dose vaccinations was 16.79% (946/5 633). No serious adverse reaction was reported. Local and systemic reactions were mainly mild. Common local reactions were pain, erythema, cutaneous nodule, etc.; and common systemic reactions were abnormal crying, drowsiness, diarrhea and appetite lost, etc.. The incidence of local reactions 30 days later after 3 basic dose vaccinations was 1.65% (93/5 633), and the incidence rates of grade 1-3 reactions were1.26% (71/5 633), 0.21% (12/5 633) and 0.20% (11/5 633) respectively. The incidence rate of systemic reactions 30 days later after 3 basic vaccinations was 15.14% (853/5 633), and the incidence rates of grade 1-3 reactions were 11.33% (638/5 633), 3.18% (179/5 633) and 0.64% (36/5 633) respectively. There were no significant differences in the rate of grade 3 reaction among different groups (χ(2)=4.17, P=0.24). Conclusions: No severe adverse reactions related to sequential vaccination of different strain inactivated polio vaccines were observed, most of reactions were mild and all of them were cured. It is safe to use sIPV and wIPV simultaneously or alternately for childhood sequential vaccination.

01 Aug 2018·Bulletin of the World Health OrganizationQ1 · MEDICINE

A post-conflict vaccination campaign, Central African Republic

Q1 · MEDICINE

Article

Author: Nzalapan, Samuel ; Dahl, Ellen ; Cabrol, Jean-Clément ; Righetti, Anna ; Rambaud, Clotilde ; Lechevalier, Pauline ; Duc, Geraldine ; Chèvre, Corinne ; Wanteu, Theo ; Sarafini, Micaela ; Bottineau, Marie-Claude ; Rull, Monica ; Albela, Manuel ; Nesbitt, Robin ; Reache, Souheil ; Peyraud, Nicolas ; Gignoux, Etienne ; Dumont, Thierry ; Quéré, Michel

OBJECTIVETo rapidly increase childhood immunization through a preventive, multi-antigen, vaccination campaign in Mambéré-Kadéï prefecture, Central African Republic, where a conflict from 2012 to 2015 reduced vaccination coverage.METHODSThe three-round campaign took place between December 2015 and June 2016 using: (i) oral poliomyelitis vaccine (OPV); (ii) combined diphtheria, tetanus and pertussis (DTP) vaccine, Haemophilus influenza type B (Hib) and hepatitis B (DTP-Hib-hepatitis B) vaccine; (iii) pneumococcal conjugate vaccine (PCV); (iv) measles vaccine; and (v) yellow fever vaccine. Administrative data were collected on vaccines administered by age group and vaccination coverage surveys were carried out before and after the campaign.FINDINGSOverall, 294 054 vaccine doses were administered. Vaccination coverage for children aged 6 weeks to 59 months increased to over 85% for the first doses of OPV, DTP-Hib-hepatitis B vaccine and PCV and, in children aged 9 weeks to 59 months, to over 70% for the first measles vaccine dose. In children aged 6 weeks to 23 months, coverage of the second doses of OPV, DTP-Hib-hepatitis B vaccine and PCV was over 58% and coverage of the third doses of OPV and DTP-Hib-hepatitis B vaccine was over 20%. Moreover, 61% (5804/9589) of children aged 12 to 23 months had received two PCV doses and 90% (25933/28764) aged 24 to 59 months had received one dose.CONCLUSIONA preventive, multi-antigen, vaccination campaign was effective in rapidly increasing immunization coverage in a post-conflict setting. To sustain high coverage, routine immunization must be reinforced.

01 Dec 2017·Journal of Medical VirologyQ4 · MEDICINE

A safe and reliable neutralization assay based on pseudovirus to measure neutralizing antibody titer against poliovirus

Q4 · MEDICINE

Article

Author: Lu, Weiwei ; Zhang, Yue ; Liu, Shaohua ; Guo, Huijie ; Li, Xiuling ; Dai, Xinxian ; Zhang, Zhongyang ; Hao, Chunsheng ; Song, Dongmei ; Bai, Han

With the promotion of inactivated poliomyelitis vaccine (IPV) and live attenuated oral poliomyelitis vaccine (OPV), the global reported cases of poliomyelitis have reduced sharply from 0.35 million in 1988 to 74 in 2015. The Polio Eradication & Endgame Strategic Plan published by WHO in 2013 included the strategy of implementation of poliovirus safe handling and containment measures to minimize the risks of facility‐associated reintroduction of virus into the polio‐free community to prevent the re‐import of poliovirus. Toward this strategy, we produced replication‐incompetent pseudovirus of poliovirus type 1, 2, 3 attenuated strains by constructing poliovirus capsid expression vectors and poliovirus replicon then transfecting HEK293T cells and developed a pseudovirus‐based neutralization assay (pNA) to determine neutralizing antibody titer which is more secure, time‐saving and reliable than conventional neutralization assay (cNA). By using anti‐poliovirus rat serum, we demonstrated excellent correlation between neutralizing antibody titers measured by cNA and pNA. It was concluded that pNA can be a potential alternative to replace cNA as a safe and time‐saving system for titer determination after live poliovirus's safekeeping.

100 Deals associated with Novel oral poliomyelitis vaccine type 1(nOPV1)(PATH)

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Indication	Highest Phase	Country/Location	Organization	Date
Poliomyelitis	Phase 2	BD	PT Bio Farma	10 Nov 2024
Poliomyelitis	Phase 2	BD	Program for Appropriate Technology in Health	10 Nov 2024

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