Immunogenicity and safety of a tetravalent dengue vaccine administered concomitantly or sequentially with quadrivalent human papillomavirus vaccine in boys and girls 9–13 years of age in Malaysia

Hassan, Jamiyah and Toh, Teck-Hock and Sivapunniam, Selva Kumar and Hasim, Ruziaton and Ghazali, Nor Faizah and Sulaiman, Sofiah and Koh, Mia Tuang and Meyer, Stephanie and Toh, Myew-Ling and Zocchetti, Celine and Vigne, Claire and Mascareñas, Cesar (2021) Immunogenicity and safety of a tetravalent dengue vaccine administered concomitantly or sequentially with quadrivalent human papillomavirus vaccine in boys and girls 9–13 years of age in Malaysia. Pediatric Infectious Disease Journal, 40 (8). pp. 774-781. ISSN 0891-3668, DOI https://doi.org/10.1097/INF.0000000000003164.

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Official URL: https://doi.org/10.1097/INF.0000000000003164

Abstract

Background: Incorporating dengue vaccination within existing vaccination programs could help improve dengue vaccine coverage. We assessed the immunogenicity and safety of a quadrivalent human papillomavirus (HPV) vaccine administered concomitantly or sequentially with a tetravalent dengue vaccine (CYD-TDV) in healthy children 9-13 years of age in Malaysia. Methods: In this phase IIIb, open-label, multicenter study (NCT02993757), participants were randomized 1:1 to receive 3 CYD-TDV doses 6 months apart and 2 doses of quadrivalent HPV vaccine concomitantly with, or 1 month before (sequentially), the first 2 CYD-TDV doses. Only baseline dengue-seropositive participants received the 3 doses. Antibody levels were measured at baseline and 28 days after each injection using an enzyme-linked immunosorbent assay for HPV-6, -9, -16 and -18, and the 50% plaque reduction neutralization test for the 4 dengue serotypes; immunogenicity results are presented for baseline dengue-seropositive participants. Safety was assessed throughout the study for all participants. Results: At baseline, 197 of 528 (37.3%) randomized participants were dengue-seropositive [n = 109 (concomitant group) and n = 88 (sequential group)]. After the last HPV vaccine dose, antibody titers for HPV among baseline dengue-seropositive participants were similar between treatment groups, with between-group titer ratios close to 1 for HPV-6 and 0.8 for HPV-11, -16, and -18. After CYD-TDV dose 3, dengue antibody titers were similar between treatment groups for all serotypes [between-group ratios ranged from 0.783 (serotype 2) to 1.07 (serotype 4)]. No safety concerns were identified. Conclusions: The immunogenicity and safety profiles of CYD-TDV and quadrivalent HPV vaccines were unaffected when administered concomitantly or sequentially in dengue-seropositive children.

Item Type: Article
Funders: UNSPECIFIED
Uncontrolled Keywords: dengue vaccine; Human papilloma virus vaccine; Immunogenicity; Malaysia; Safety
Subjects: R Medicine
R Medicine > RJ Pediatrics
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 22 Feb 2022 04:33
Last Modified: 22 Feb 2022 04:33
URI: http://eprints.um.edu.my/id/eprint/26268

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