Assessing the mucosal intestinal and systemic humoral immunity of sequential schedules of inactivated poliovirus vaccine and bivalent oral poliovirus vaccine for essential immunization in Bangladesh: An open-label, randomized controlled trial.

Autor: Snider CJ; U.S. Centers for Disease Control and Prevention, 1600 Clifton Road Northeast, Atlanta, GA 30329, USA., Zaman K; icddr,b, 68 Shahid Tajuddin Ahmed Sarani, Dhaka 1212, Bangladesh., Estivariz CF; U.S. Centers for Disease Control and Prevention, 1600 Clifton Road Northeast, Atlanta, GA 30329, USA. Electronic address: cge3@cdc.gov., Aziz AB; icddr,b, 68 Shahid Tajuddin Ahmed Sarani, Dhaka 1212, Bangladesh., Yunus M; icddr,b, 68 Shahid Tajuddin Ahmed Sarani, Dhaka 1212, Bangladesh., Haque W; icddr,b, 68 Shahid Tajuddin Ahmed Sarani, Dhaka 1212, Bangladesh., Hendley WS; U.S. Centers for Disease Control and Prevention, 1600 Clifton Road Northeast, Atlanta, GA 30329, USA., Weldon WC; U.S. Centers for Disease Control and Prevention, 1600 Clifton Road Northeast, Atlanta, GA 30329, USA., Oberste MS; U.S. Centers for Disease Control and Prevention, 1600 Clifton Road Northeast, Atlanta, GA 30329, USA., Pallansch MA; U.S. Centers for Disease Control and Prevention, 1600 Clifton Road Northeast, Atlanta, GA 30329, USA., Wassilak SGF; U.S. Centers for Disease Control and Prevention, 1600 Clifton Road Northeast, Atlanta, GA 30329, USA., Anand A; U.S. Centers for Disease Control and Prevention, 1600 Clifton Road Northeast, Atlanta, GA 30329, USA.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2024 Sep 17; Vol. 42 (22), pp. 126216. Date of Electronic Publication: 2024 Aug 14.
DOI: 10.1016/j.vaccine.2024.126216
Abstrakt: In 2012, the Strategic Advisory Group of Experts on Immunization (SAGE) recommended introduction of at least one inactivated poliovirus vaccine (IPV) dose in essential immunization programs. We evaluated systemic humoral and intestinal mucosal immunity of a sequential IPV-bivalent oral poliovirus vaccine (bOPV) schedule compared with a co-administration IPV + bOPV schedule in an open-label, randomized, controlled, non-inferiority, inequality trial in Dhaka, Bangladesh. Healthy infants aged 6 weeks were randomized to either: (A) IPV and bOPV at 6 and bOPV at 10 and 14 weeks (IPV + bOPV-bOPV-bOPV); or (B) IPV at 6 and bOPV at 10 and 14 weeks (IPV-bOPV-bOPV). Of 456 participants enrolled and randomly assigned during May-August 2015, 428 (94%) were included in the modified intention-to-treat analysis (arm A: 211, arm B: 217). Humoral immune responses did not differ at 18 weeks between study arms: type 1 (98% versus 96%; p = 0.42), type 2 (37% versus 39%; p = 0.77), and type 3 (97% versus 93%; p = 0.07). Virus shedding one week after the bOPV challenge dose in arm B was non-inferior to arm A (type 1 difference = -3% [90% confidence interval: -6 - 0.4%]; type 3 difference: -3% [-6 to -0.2%]). Twenty-six adverse events including seven serious adverse events were reported among 25 participants including one death; none were attributed to study vaccines. An IPV-bOPV-bOPV sequential schedule induced comparable systemic humoral immunity to all poliovirus types and types 1 and 3 intestinal mucosal immunity as an IPV + bOPV-bOPV-bOPV co-administration schedule.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Khalequ Zaman, Asma Binte Aziz, Mohammad Yunus, Warda Haque b reports financial support was provided by Centers for Disease Control and Prevention. Cynthia J Snider’s spouse previously owned stock in Sanofi Pasteur
(Published by Elsevier Ltd.)
Databáze: MEDLINE
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