Key result
Novel type 2 oral poliovirus vaccine candidates were safe and noninferior to monovalent OPV2 for day 28 seroprotection in infants (e.g., 94% for high-dose OPV2-c1 vs 94% for monovalent OPV2).
Why the study?
Emergence and spread of circulating vaccine-derived type 2 polioviruses and vaccine-associated paralytic poliomyelitis from Sabin oral poliovirus vaccines prompted development of two novel type 2 candidates designed for improved genetic stability and reduced neurovirulence.
Do novel type 2 oral poliovirus vaccine candidates provide non-inferior seroprotection and safety compared to monovalent Sabin OPV2 in healthy children and infants?
RCT (n=834)
partly-masked
randomised
Yes
Do novel type 2 oral poliovirus vaccine candidates provide non-inferior seroprotection and safety compared to monovalent Sabin OPV2 in healthy children and infants?
Absolute Event Rate: 94% vs 94%
Novel type 2 oral poliovirus vaccine candidates are safe, well-tolerated, and provide non-inferior immunogenicity compared to monovalent OPV2 in children and infants.
No takes yet. Share an insight, caveat, or question.
Supports novel OPV2 deployment in eradication programs; extends RCT evidence to new type 2 candidates in infants.
Sáez‐Llorens et al. (2020) conducted an RCT in Healthy children and infants (n=834). Novel type 2 oral poliovirus vaccine candidates (OPV2-c1 and OPV2-c2) vs. Monovalent Sabin OPV2 was evaluated on Safety in all participants and non-inferiority of novel OPV2 day 28 seroprotection versus monovalent OPV2 in infants. Novel type 2 oral poliovirus vaccine candidates were safe and noninferior to monovalent OPV2 for day 28 seroprotection in infants (e.g., 94% for high-dose OPV2-c1 vs 94% for monovalent OPV2).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: