This is an open-label randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.

开始日期2021-02-08

申办/合作机构

Centers for Disease Control & Prevention

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100 项与 Novel monovalent oral poliovirus vaccine type 2 (nOPV2)(International Centre for Diarrhoeal Disease Research) 相关的临床结果

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100 项与 Novel monovalent oral poliovirus vaccine type 2 (nOPV2)(International Centre for Diarrhoeal Disease Research) 相关的转化医学

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100 项与 Novel monovalent oral poliovirus vaccine type 2 (nOPV2)(International Centre for Diarrhoeal Disease Research) 相关的专利（医药）

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项与 Novel monovalent oral poliovirus vaccine type 2 (nOPV2)(International Centre for Diarrhoeal Disease Research) 相关的文献（医药）

2024-09-01·Journal of Virological Methods

Qualitative real-time RT-PCR assay for nOPV2 poliovirus detection

Article

作者: Antonov, S A ; Kanaeva, O I ; Dolgova, A S ; Klyuchnikova, E O ; Kozlovskaya, L I ; Gladkikh, A S ; Sbarzaglia, V A ; Shabalina, A V ; Ivanova, O E ; Dedkov, V G

Based on the success of the Sabin2-based vaccine, a next-generation nOPV2 poliovirus vaccine has been developed. For epidemic monitoring and conducting epidemiological investigations, it is necessary to have a diagnostic assay with the ability to differentiate this variant from others. Here we describe such a real-time RT-PCR assay. The region with the cre insertion in the 5'-UTR was chosen as the target, and the limit of detection was 10³ copies/mL (2.5×10³ copies/mL using Probit analysis) determined using armored RNA particles. Sensitivity and specificity were 86.28 - 100 % and 76.84 - 100 %, respectively (with 95 % CI). Thus, this method can be effectively used when it is necessary to make a differential diagnosis of poliovirus strains.

2024-04-01·The Lancet Infectious Diseases

Novel oral poliovirus vaccine type 2 is an important eradication tool, but reaching every last child remains vital

Article

作者: Kotei, Larry ; Clarke, Ed

2024-03-01·The Lancet1区 · 医学

Safety of the novel oral poliovirus vaccine type 2 (nOPV2) in infants and young children aged 1 to <5 years and lot-to-lot consistency of the immune response to nOPV2 in infants in The Gambia: a phase 3, double-blind, randomised controlled trial

1区 · 医学

Article

作者: Umesi, Ama ; Konz, John O ; Jones, Kathryn A V ; Donkor, Simon A ; Gast, Chris ; Tritama, Erman ; Oyadiran, Oluwafemi ; Njie, Anna ; Fix, Alan ; Jallow, Musa ; Abid, Talha ; Kotei, Larry ; Edem, Bassey ; Affleck, Lucy ; Ochoge, Magnus ; Saidy-Jah, Ebrima ; Clarke, Ed ; Futa, Ahmed Cherno ; Mainou, Bernardo A ; Daffeh, Baboucarr ; Jallow, Edrissa

BACKGROUNDNovel oral poliovirus vaccine type 2 (nOPV2) has been engineered to improve the genetic stability of Sabin oral poliovirus vaccine (OPV) and reduce the emergence of circulating vaccine-derived polioviruses. This trial aimed to provide key safety and immunogenicity data required for nOPV2 licensure and WHO prequalification.METHODSThis phase 3 trial recruited infants aged 18 to <52 weeks and young children aged 1 to <5 years in The Gambia. Infants randomly assigned to receive one or two doses of one of three lots of nOPV2 or one lot of bivalent OPV (bOPV). Young children were randomised to receive two doses of nOPV2 lot 1 or bOPV. The primary immunogenicity objective was to assess lot-to-lot equivalence of the three nOPV2 lots based on one-dose type 2 poliovirus neutralising antibody seroconversion rates in infants. Equivalence was declared if the 95% CI for the three pairwise rate differences was within the -10% to 10% equivalence margin. Tolerability and safety were assessed based on the rates of solicited adverse events to 7 days, unsolicited adverse events to 28 days, and serious adverse events to 3 months post-dose. Stool poliovirus excretion was examined. The trial was registered as PACTR202010705577776 and is completed.FINDINGSBetween February and October, 2021, 2345 infants and 600 young children were vaccinated. 2272 (96·9%) were eligible for inclusion in the post-dose one per-protocol population. Seroconversion rates ranged from 48·9% to 49·2% across the three lots. The minimum lower bound of the 95% CIs for the pairwise differences in seroconversion rates between lots was -5·8%. The maximum upper bound was 5·4%. Equivalence was therefore shown. Of those seronegative at baseline, 143 (85·6%) of 167 (95% CI 79·4-90·6) infants and 54 (83·1%) of 65 (71·7-91·2) young children seroconverted over the two-dose nOPV2 schedule. The post-two-dose seroprotection rates, including participants who were both seronegative and seropositive at baseline, were 604 (92·9%) of 650 (95% CI 90·7-94·8) in infants and 276 (95·5%) of 289 (92·4-97·6) in young children. No safety concerns were identified. 7 days post-dose one, 78 (41·7%) of 187 (95% CI 34·6-49·1) infants were excreting the type 2 poliovirus.INTERPRETATIONnOPV2 was immunogenic and safe in infants and young children in The Gambia. The data support the licensure and WHO prequalification of nOPV2.FUNDINGBill & Melinda Gates Foundation.

项与 Novel monovalent oral poliovirus vaccine type 2 (nOPV2)(International Centre for Diarrhoeal Disease Research) 相关的新闻（医药）

2022-11-08

·Business Wire

PharmaJet Needle-free System Selected to Deliver Intradermal Polio Vaccine in Nigerian Campaign

GOLDEN, Colo.--( BUSINESS WIRE )-- PharmaJet ® , a company that has developed and commercialized a needle-free platform to more effectively administer drugs and biologics, today announced that their PharmaJet Tropis® Needle-free Injection System (NFIS) will be used in a door-to-door immunization campaign aimed at reducing the outbreak of circulating mutant poliovirus Type 2 (cMPV2). The initial pilot, targeting thousands of children under 5 years of age in the Sokoto North local government area (LGA) of Nigeria, will begin on November 5, 2022 and run for 4 days. Since 1988, the world has made great progress in the global effort to eradicate polio, with wild polio cases dropping by 99.9%. 1 However, in areas with low levels of population immunity, the live, weakened virus contained in the oral polio vaccine (OPV) can genetically revert into a form known as circulating vaccine-derived poliovirus (cVDPV) that can cause paralysis. Type 2 cVDPV (cVDPV2) now accounts for most of the cVDPV cases globally, and is a major challenge to achieving global eradication. In Nigeria, 415 cases of cVDPV2 were reported in 2021 2 which also resulted in polio spreading to neighboring countries. Despite massive supplemental immunization activities (SIAs) the virus continues to circulate. The Global Polio Eradication Initiative (GPEI) is supporting a new approach that uses a type 2 novel OPV (nOPV2), a next generation version approved for emergency use by the World Health Organization (WHO), that has demonstrated in clinical trials to be safe and effective. The Nigeria pilot campaign will combine the nOPV2 oral vaccine with an intradermal polio vaccine (1/5 of a full IPV dose) administered with the PharmaJet Tropis NFIS. If the approach is successful, with coverage greater than 90% for the pilot phase and a decrease in zero-dose children under routine immunization (RI), the pilot could be replicated in other States/LGAs in Nigeria and beyond. “We are pleased to be selected for the polio vaccine campaign in Nigeria to curtail the spread of cVDPV2,” said Chris Cappello, President and CEO of PharmaJet. “Intradermal administration of polio vaccine with the PharmaJet Tropis NFIS has already been successfully used in mass vaccination campaigns in Somalia, Pakistan, Cuba, and The Gambia. The ease-of-use, coupled with patient and healthcare worker preference make the NFIS ideal for field immunizations.” For more information about PharmaJet visit https://pharmajet.com . Refer to Instructions for Use to ensure safe injections and to review risks. 1 https://polioeradication.org/wp-content/uploads/2022/10/GPEI-nOPV2-Factsheet-EN-20221011.pdf 2 https://polioeradication.org/where-we-work/nigeria/ About PharmaJet PharmaJet’s mission is to enable greater access to life improving pharmaceuticals. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis ® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis ® System has CE Mark and WHO PQS certification for intradermal injections. For more information visit https://pharmajet.com . Follow us on LinkedIn . About the Global Polio Eradication Initiative (GPEI) The Global Polio Eradication Initiative is a public-private partnership led by national governments with six partners – the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC), the United Nations Children’s Fund (UNICEF), Bill & Melinda Gates Foundation and Gavi, the vaccine alliance. Its goal is to eradicate polio worldwide.