nOPV2M4a Polio Vaccine Description
nOPV2M4a Polio Vaccine candidate is derived from the live, infectious virus, but it has been ‘triple-locked’ using genetic engineering, to prevent it from becoming harmful. nOPV2M4a is genetically more stable than existing OPVs, with a lower risk of reversion to neurovirulence.
nOPV2 vaccine candidates have been developed as attenuated serotype 2 polioviruses derived from a modified Sabin 2 infectious cDNA clone. nOPV2 Candidate 1 (S2/cre5/S15domV/rec1/hifi3) and nOPV2 Candidate 2 (S2/S15domV/CpG40) were generated by modifying the Sabin-2 RNA sequence to improve phenotypic stability and make the strains less prone to reversion to virulence.
Bio Farma is one of about 29 vaccine manufacturers in 22 countries around the world that have obtained the World Health Organization Prequalification so it is trusted to meet vaccine needs in more than 130 countries.
nOPV2M4a Polio Vaccine Indication
nOPV2M4a Polio Vaccine is indicated to prevent circulating vaccine-derived polio-virus (cVDPV) polio cases. Most cases of cVDPV are caused by mutations in a strain of poliovirus called type 2.
The novel vaccine will eventually be licensed based on 3 criteria: a similar safety profile to the currently licensed mOPV2 of the Sabin strain, non-inferior immunogenicity, and reduced reversion to virulence.
nOPV2M4a Polio Vaccine News
November 13, 2020 - Te World Health Organization’s Prequalification program issued an Emergency Use Listing recommendation for the type 2 novel oral polio vaccine (nOPV2). This will allow the rollout of the vaccine for limited initial use in countries affected by circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks.
October 29, 2020 - New polio vaccine which is designed to prevent harmful mutations poised to get emergency WHO approval.
October 22, 2020 - The twenty-sixth meeting of the Emergency Committee under the International Health Regulations (2005) on the international spread of poliovirus was convened. The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine-derived polioviruses (cVDPV). The following IHR States Parties provided an update at the video conference or in writing on the current situation in their respective countries: Afghanistan, Chad, Egypt, Guinea, Pakistan, Somalia, South Sudan, Sudan, and Yemen.
July 13, 2019 - The safety and immunogenicity of novel live attenuated monovalent (serotype 2) oral poliovirus vaccines in healthy adults: a double-blind, single-center phase 1 study.
April 4, 2019 - The UNICEF Supply Division Team from Copenhagen came to Bio Farma to discuss the joint procurement of mOPV2 global stockpiling in the form of a final product of 60 million doses or 3 million vials that must be prepared in 2019.
nOPV2M4a Polio Vaccine Clinical Studies
Clinical Trial NCT04544787: A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates. Last Update Posted: September 10, 2020.
- The Phase 2 study is designed to evaluate the safety and immunogenicity of both nOPV2 vaccines in adults before testing in young children and then infants.
- The primary objectives of the Phase 2 study include the general safety and immunogenicity of the two candidate vaccines, primarily based on comparison with historical data obtained in the Phase 4 study of Sabin mOPV2 for OPV-vaccinated subjects, in order to establish non-inferior immunogenicity and acceptable safety profile.
- Assessment of the general safety of the 2 candidate vaccines in IPV-only vaccinated subjects will be based on comparison with data from a placebo group
Clinical Trial NCT03430349: Phase 1 Novel Live Attenuated Serotype 2 Oral Polio Vaccine Study in IPV Primed Adults (nOPV2M4a)
- This first-in-human (FIH) phase 1 study is designed to evaluate in contained conditions the safety, immunogenicity, shedding, and genetic stability of both nOPV2 vaccine candidates in IPV-primed adults before testing in a larger adult and adolescent (> 15 y of age) population, and then in young children and infants.
- The primary objectives of the subsequent Phase 1 and 2 studies will include the general safety, the shedding, and genetic stability of the two candidate vaccines, primarily based on comparison with historical data obtained in the Phase 4 studies of Sabin mOPV2.