Browsing by Author "Pittayawonganon C."

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    Genetic basis of sudden death after COVID-19 vaccination in Thailand
    (2022-11-01) Ittiwut C.; Mahasirimongkol S.; Srisont S.; Ittiwut R.; Chockjamsai M.; Durongkadech P.; Sawaengdee W.; Khunphon A.; Larpadisorn K.; Wattanapokayakit S.; Wetchaphanphesat S.; Arunotong S.; Srimahachota S.; Pittayawonganon C.; Thammawijaya P.; Sutdan D.; Doungngern P.; Khongphatthanayothin A.; Kerr S.J.; Shotelersuk V.; Mahidol University
    Background: Severe acute respiratory syndrome coronavirus 2 vaccination reduces morbidity and mortality associated with coronavirus disease 2019 (COVID-19); unfortunately, it is associated with serious adverse events, including sudden unexplained death (SUD). Objective: We aimed to study the genetic basis of SUD after COVID-19 vaccination in Thailand. Methods: From April to December 2021, cases with natural but unexplained death within 7 days of COVID-19 vaccination were enrolled for whole exome sequencing. Results: Thirteen were recruited, aged between 23 and 72 years; 10 (77%) were men, 12 were Thai; and 1 was Australian. Eight (61%) died after receiving the first dose of vaccine, and 7 (54%) died after receiving ChAdOx1 nCoV-19; however, there were no significant correlations between SUD and either the number or the type of vaccine. Fever was self-reported in 3 cases. Ten (77%) and 11 (85%) died within 24 hours and 3 days of vaccination, respectively. Whole exome sequencing analysis revealed that 5 cases harbored SCN5A variants that had previously been identified in patients with Brugada syndrome, giving an SCN5A variant frequency of 38% (5 of 13). This is a significantly higher rate than that observed in Thai SUD cases occurring 8–30 days after COVID-19 vaccination during the same period (10% [1 of 10]), in a Thai SUD cohort studied before the COVID-19 pandemic (12% [3 of 25]), and in our in-house exome database (12% [386 of 3231]). Conclusion: These findings suggest that SCN5A variants may be associated with SUD within 7 days of COVID-19 vaccination, regardless of vaccine type, number of vaccine dose, and presence of underlying diseases or postvaccine fever.
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    Safety and immunogenicity of locally produced trivalent inactivated influenza vaccine (Tri Fluvac) in healthy Thai adults aged 18–64 years in Nakhon Phanom: A Phase III double blinded, three-arm, randomized, controlled trial
    (2023-01-01) Prasert K.; Praphasiri P.; Lerdsamran H.; Nakphook S.; Ditsungnoen D.; Chawalchitiporn S.; Sornwong K.; Poopipatpol K.; Wirachwong P.; Narakorn P.; Surichan S.; Suthepakul N.; Thangsupanimitchai N.; Pittayawonganon C.; Puthavathana P.; Davis W.W.; Mott J.A.; Olsen S.J.; Patumanond J.; Mahidol University
    Background: Domestic influenza vaccine production facilitates a sustainable supply for mitigating seasonal influenza and improves national health security by providing infrastructure and experience for pandemic vaccine production, if needed. Methods: A Phase III, double blind, randomized controlled trial was conducted from Sep 2019-Oct 2020 in healthy adults 18–64 years in Nakhon Phanom, Thailand. Randomization (3:3:1) compared study vaccine (Tri Fluvac), saline placebo, and an active comparator (licensed vaccine). Primary outcomes were superior efficacy compared to placebo based on RT-PCR-confirmed influenza virus infection within 12 months and non-inferiority compared to active comparator based on immunogenicity (HAI assay) at 28 days. Safety was also assessed. Results: The trial enrolled 4,284 participants (Tri Fluvac = 1,836; placebo = 1,836; active comparator = 612). There were 29 RT-PCR positive influenza infections (10 Tri Fluvac, 5.5/1,000 PY; 19 placebo, 10.4/1,000PY; 0 comparator) for an absolute protective efficacy of 46.4 (95 % CI = −22.0–76.5) compared with placebo, but the power was 43.7 %. Seroconversion difference rates between Tri Fluvac and comparator at Day 28 were 1.74 (95 % CI: −2.77, 6.25), 2.22 (−2.40, 6.84), and −0.57 (−5.41, 4.27) for A(H1N1), A(H3N2), and B strains, respectively. Adverse and severe adverse events occurred in 175 (9.5 %) Tri Fluvac, 177 (10.8 %) placebo, and 66 (10.8 %) comparator arms (p-value = 0.437, Tri Fluvac vs. comparator) Conclusions: Tri Fluvac was well tolerated, and immunogenicity was non-inferior to the active comparator, meeting U.S. Food and Drug Administration (FDA) criteria for adult vaccine licensure. Few acute respiratory infections were reported during intense COVID-19 pandemic restrictions, resulting in insufficient power to evaluate clinical efficacy.