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Zaman, Khalequ; Kingma, Robert; Yunus, Md; van Straaten, Ineke; Mekkes, Dirk; Bouwstra, Xandra; Gunale, Bhagwat; Kulkarni, Prasad S.
Vaccine, 07/2019, Volume: 37, Issue: 31Journal Article
Poliomyelitis infection continues to be endemic in few countries despite rigorous efforts for eradication. A new Bivalent Oral Polio Vaccine (BBio bOPV) was tested in a Phase III Clinical study. An observer blind, randomized, controlled clinical study was conducted comparing BBio bOPV with a licensed bOPV (SII bOPV). Initially in Part 1, 40 children 5–6 years of age were given a single dose of either vaccine in 1:1 ratio. In Part 2, 1080 infants of 6–8 weeks of age were received in 1:1:1:1 ratio one of the 3 lots of BBio bOPV or SII bOPV at 6, 10 and 14 weeks of age. Blood samples were collected to assess neutralizing antibody responses against Polio Type 1 and 3 viruses. Safety of the vaccines were recorded. All children were seroprotected against both Type 1 and Type 3 polioviruses post-vaccination. More than 96% of the infants demonstrated seroconversion as well as seroprotection against both types of polioviruses. The geometric mean titres (GMT) for Type 1 and Type 3 antibodies were comparable between the groups. The 3 lots of BBio bOPV generated similar GMTs of Type 1 and Type 3 antibodies. In total 387 participants reported at least one adverse event and 18 serious adverse events. None of these events were vaccine related. The new bOPV vaccine demonstrated immunogenicity that was non-inferior to a licensed bOPV vaccine. Consistency in immune response by 3 consecutively manufactured lots was also demonstrated. The vaccine did not cause any adverse event. Clinicaltrials.gov.identifier: NCT02766816.
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