Effect of Inactivated Poliovirus Vaccine on Nasal Mucosal Immunity and Pharyngeal Shedding Following Novel Oral Poliovirus Vaccine Type 2 Challenge: A Randomized, Open-label Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Impact of prior inactivated poliovirus vaccine (IPV) doses on nasal and pharyngeal viral replication following subsequent poliovirus exposure remains unclear. Circulating vaccine-derived poliovirus detection in IPV-only countries necessitates better understanding of IPV's role in inducing nasal and pharyngeal mucosal immunity. METHODS: This multicenter, randomized, open-label, parallel-group trial (9 November 2023-25 August 2024; ClinicalTrials.gov identifier: NCT05677256) was conducted in Bangladesh in 500 polio vaccine-naïve infants aged 6-8 weeks. Two infant cohorts (vaccinated with 3 doses of either IPV or bivalent oral poliovirus vaccine [bOPV]) were challenged at 18-20 weeks with novel OPV type 2 (nOPV2). Pharyngeal and fecal viral shedding, and nasal, intestinal, and serum immune responses were measured post-nOPV2-challenge. RESULTS: Poliovirus type 2 (PV2) pharyngeal shedding was minimal post-challenge (1.7% of IPV-vaccinated and 2.6% of bOPV-vaccinated infants). Nasal PV2-specific neutralizing antibody titers were higher in the IPV group post-nOPV2-challenge (day 14; geometric mean titers [GMT]: IPV, 7.5 [95% CI: 5.1-11.1] vs bOPV, 0.6 [95% CI: 0.3-1.2]). Stool PV2-specific neutralization titers were comparable at day 14 (GMT: IPV, 124.0 [95% CI: 54.7-281.0] vs bOPV, 127.3 [95% CI: 74.0-218.9]). Serum PV2 neutralizing antibody titers were consistently higher in IPV group, peaking at day 28 (GMT: IPV, 4347.4 [95% CI: 2378.2-7947.2] vs bOPV, 259.9 [95% CI: 115.5-584.9]). CONCLUSIONS: nOPV2 pharyngeal shedding was low following IPV or bOPV vaccination, whereas IPV induced higher nasal and serum, and comparable intestinal PV2-specific immunity, suggesting a potential role for IPV in poliovirus outbreak response in IPV-only settings.
Authors: Khalequ Zaman, Ananda S Bandyopadhyay, Chris Gast, Doli R Goswami, Masuma Hoque, Rubhana Raqib, Lokman Hossain, Warda Haque, Arifa Islam, Harun-or Rashid, Mustafizur Rahman, Gabriela Aguirre, Elizabeth B Brickley, Audrey Godin, Joshua A Weiner, Rachel M Burke, Margaret E Ackerman, Giovanna Sifontes, Bernardo A Mainou, Peter F Wright, Ricardo Rüttimann
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,763
Awards: CDC Foundation - to maintain lab support for key clinical studies related to polio endgame, Dartmouth-Hitchcock Clinic - to support use of assays to measure mucosal immunity in polio vaccine studies, Dartmouth-Hitchcock Clinic - to develop more accurate and timely measurement of population immunity generated by polio vaccines, FIDEC Corporation - to generate data on the impact of IPV on pharyngeal immunity in OPV-naïve infants
OpenAlex ID: W7203708808