Immunogenicity and reactogenicity of fractional, heterologous primary COVID-19 vaccination schedules with BNT162b2 boosters in 5–11-year-old Thai children: A multicenter, prospective, double-blind, randomized control trial
Issued Date
2023-01-01
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-85169790649
Pubmed ID
37586956
Journal Title
Vaccine
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine (2023)
Suggested Citation
Wittawatmongkol O., Bunjoungmanee P., Kosalaraksa P., Laoprasopwattana K., Boonsathorn S., Chantasrisawad N., Sudjaritruk T., Niyomnaitham S., Senawong S., Srisutthisamphan K., Quan Toh Z., Rungmaitree S., Nanthapisal S., Phanthanawiboon S., Khantee P., Techasaensiri C., Hirankarn N., Pangprasertkul S., Chokephaibulkit K. Immunogenicity and reactogenicity of fractional, heterologous primary COVID-19 vaccination schedules with BNT162b2 boosters in 5–11-year-old Thai children: A multicenter, prospective, double-blind, randomized control trial. Vaccine (2023). doi:10.1016/j.vaccine.2023.08.021 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/89998
Title
Immunogenicity and reactogenicity of fractional, heterologous primary COVID-19 vaccination schedules with BNT162b2 boosters in 5–11-year-old Thai children: A multicenter, prospective, double-blind, randomized control trial
Author(s)
Wittawatmongkol O.
Bunjoungmanee P.
Kosalaraksa P.
Laoprasopwattana K.
Boonsathorn S.
Chantasrisawad N.
Sudjaritruk T.
Niyomnaitham S.
Senawong S.
Srisutthisamphan K.
Quan Toh Z.
Rungmaitree S.
Nanthapisal S.
Phanthanawiboon S.
Khantee P.
Techasaensiri C.
Hirankarn N.
Pangprasertkul S.
Chokephaibulkit K.
Bunjoungmanee P.
Kosalaraksa P.
Laoprasopwattana K.
Boonsathorn S.
Chantasrisawad N.
Sudjaritruk T.
Niyomnaitham S.
Senawong S.
Srisutthisamphan K.
Quan Toh Z.
Rungmaitree S.
Nanthapisal S.
Phanthanawiboon S.
Khantee P.
Techasaensiri C.
Hirankarn N.
Pangprasertkul S.
Chokephaibulkit K.
Author's Affiliation
Siriraj Hospital
Faculty of Medicine, Chiang Mai University
University of Melbourne
Faculty of Medicine, Khon Kaen University
Faculty of Medicine, Prince of Songkia University
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Faculty of Medicine, Thammasat University
Thailand National Center for Genetic Engineering and Biotechnology
Murdoch Children's Research Institute
Faculty of Medicine, Chulalongkorn University
Faculty of Medicine, Chiang Mai University
University of Melbourne
Faculty of Medicine, Khon Kaen University
Faculty of Medicine, Prince of Songkia University
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Faculty of Medicine, Thammasat University
Thailand National Center for Genetic Engineering and Biotechnology
Murdoch Children's Research Institute
Faculty of Medicine, Chulalongkorn University
Other Contributor(s)
Abstract
Objective: To evaluate immunogenicity and safety of heterologous COVID-19 primary vaccination regimens of CoronaVac with fractional and standard BNT162b2 dosages in 5–11-year-old Thai children. Methods: This prospective, multicenter, double-blind, randomized control trial divided participants 1:1:1:1 to receive a second dose of either standard (10-μg) or half-dose (5-μg) BNT162b2 vaccines as follows: CoronaVac/10-μg-BNT162b2 (Group 1), CoronaVac/5-μg-BNT162b2 (Group 2), 10-μg-BNT162b2/10-μg-BNT162b2 (Group 3), or 10-μg-BNT162b2/5-μg-BNT162b2 (Group 4). A subset of participants from each arm received 10-μg-BNT162b2 booster (third) doses 16 weeks after their second vaccination. Humoral and cellular immunogenicity were assessed and adverse events (AEs) digitally self-reported. Results: Of 553 enrolled participants, 50 % were male, the median (interquartile range) age was 8.65 (7.00, 10.00) years, and a majority (91 %) had normal weight-for-height. All participants exhibited similarly robust neutralizing antibodies (NAb) against the ancestral Wuhan strain two weeks after the second vaccination, with titers highest in Group 1 (737.60, 95% CI [654.80, 830.88]), followed by Groups 3 (630.42, 95% CI [555.50, 715.45]), 2 (593.98, 95% CI [506.02, 697.23]), and 4 (451.79, 95% CI [388.62, 525.23]), as well as 56.01 % and 49.68 % seroconversion for BA.1 and BA.5, respectively. Half-dose BNT162b2 as a second dose induced significantly lower NAb titers compared to their respective full-dose regimens (p = 0.03 for Groups 1 vs 2 and p < 0.001 for Groups 3 vs 4). 77.71 % of participants developed SARS-CoV-2 ancestral spike protein-specific T-cell responses two weeks after the second vaccination. This was similar across arms. Booster doses generated NAb titers 5.69–11.51-folds higher than the second vaccination against BA.1. AEs were similar across arms, all mild or moderate, and fully resolved 2–3 days thereafter. Conclusion: Standard and fractional heterologous regimens of CoronaVac-BNT162b2 induced similar or higher humoral immunity than homologous BNT162b2 and represent alternative vaccine regimens for children. These findings are highly relevant in settings concurrently using both vaccines.