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: A Phase IIIb, Randomized, Open-label Study. Issue 8 (12th July 2021)

• Record Type: Journal Article
• Authors: Hassan, Jamiyah; Toh, Teck-Hock; Sivapunniam, Selva Kumar; Hasim, Ruziaton; Ghazali, Nor Faizah; Sulaiman, Sofiah; Koh, Mia Tuang; Meyer, Stephanie; Toh, Myew-Ling; Zocchetti, Celine; Vigne, Claire; Mascareñas, Cesar
• Is Part Of: Pediatric infectious disease journal. Volume 40:Issue 8(2021)
• Page Start: 774
• Page End: 781
• Publication Date: 2021-07-12
• Subjects: dengue vaccine -- human papillomavirus vaccine -- immunogenicity -- Malaysia -- safety; Communicable diseases in children -- Periodicals; Infection in children -- Periodicals; 618.929
• DOI: 10.1097/INF.0000000000003164
• Languages: English
• ISSNs: 0891-3668

Abstract

Abstract : Supplemental Digital Content is available in the text. 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.