nOPV2M4a Polio Vaccine — Precision Vaccinations - PrecisionVaccinations

nOPV2M4a Polio Vaccine Description

nOPV2M4a Polio Vaccine candidate is derived from the live, infectious virus — but this time 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.

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.

nOPV2M4a Polio Vaccine News

October 29, 2020 - New polio vaccine which is designed to prevent harmful mutations poised to get emergency WHO approval

July 13, 2019 - The safety and immunogenicity of two novel live attenuated monovalent (serotype 2) oral poliovirus vaccines in healthy adults: a double-blind, single-centre phase 1 study

nOPV2M4a Polio Vaccine Clinical Studies

Clinical Trial NCT04544787: A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates

• 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.