PMID- 37439770 OWN - NLM STAT- MEDLINE DCOM- 20230721 LR - 20230905 IS - 2164-554X (Electronic) IS - 2164-5515 (Print) IS - 2164-5515 (Linking) VI - 19 IP - 2 DP - 2023 Aug 1 TI - Immunogenicity and reactogenicity of heterologous COVID-19 vaccination in pregnant women. PG - 2228670 LID - 10.1080/21645515.2023.2228670 [doi] LID - 2228670 AB - This open-labeled non-inferiority trial evaluated immunogenicity and reactogenicity of heterologous and homologous COVID-19 vaccination schedules in pregnant Thai women. 18-45-year-old pregnant women with no history of COVID-19 infection or vaccination and a gestational age of >/=12 weeks were randomized 1:1:1 into three two-dose primary series scheduled 4 weeks apart: BNT162b2-BNT162b2 (Group 1), ChAdOx1-BNT162b2 (Group 2), and CoronaVac-BNT162b2 (Group 3). Serum antibody responses, maternal and cord blood antibody levels at delivery, and adverse events (AEs) following vaccination until delivery were assessed. The 124 enrolled participants had a median age of 31 (interquartile range [IQR] 26.0-35.5) years and gestational age of 23.5 (IQR 18.0-30.0) weeks. No significant difference in anti-receptor binding domain (RBD) IgG were observed across arms at 2 weeks after the second dose. Neutralizing antibody geometric mean titers against the ancestral Wuhan strain were highest in Group 3 (258.22, 95% CI [187.53, 355.56]), followed by Groups 1 (187.47, 95% CI [135.15, 260.03]) and 2 (166.63, 95% CI [124.60, 222.84]). Cord blood anti-RBD IgG was correlated with, and equal to or higher than, maternal levels at delivery (r = 0.719, P < .001) and inversely correlated with elapsed time after the second vaccination (r = -0.366, P < .001). No significant difference in cord blood antibody levels between groups were observed. Local and systemic AEs were mild-to-moderate and more frequent in Group 2. Heterologous schedules of CoronaVac-BNT162b2 or ChAdOx1-BNT162b2 induced immunogenicity on-par with BNT162b2-BNT162b2 and may be considered as alternative schedules for primary series in pregnant women in mRNA-limited vaccine settings. FAU - Chayachinda, Chenchit AU - Chayachinda C AD - Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Watananirun, Kanokwaroon AU - Watananirun K AD - Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Phatihattakorn, Chayawat AU - Phatihattakorn C AD - Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Anuwutnavin, Sanitra AU - Anuwutnavin S AD - Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Niyomnaitham, Suvimol AU - Niyomnaitham S AD - Siriraj Institute of Clinical Research (SICRES), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. AD - Department of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Phongsamart, Wanatpreeya AU - Phongsamart W AD - Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Lapphra, Keswadee AU - Lapphra K AD - Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Wittawatmongkol, Orasri AU - Wittawatmongkol O AD - Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Rungmaitree, Supattra AU - Rungmaitree S AD - Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Jansarikit, Laddawan AU - Jansarikit L AD - Department of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Boonnak, Kobporn AU - Boonnak K AD - Department of Immunology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Wongprompitak, Patimaporn AU - Wongprompitak P AD - Department of Immunology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Senawong, Sansnee AU - Senawong S AD - Department of Immunology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. FAU - Upadhya, Avishek AU - Upadhya A AD - Department of Sciences, Mahidol University International College, Salaya, Nakhon Pathom, Thailand. FAU - Toh, Zheng Quan AU - Toh ZQ AD - Infection and Immunity, Murdoch Children's Research Institute, Parkville, Victoria, Australia. AD - Department of Pediatrics, The University of Melbourne, Parkville, Victoria, Australia. FAU - Licciardi, Paul V AU - Licciardi PV AD - Infection and Immunity, Murdoch Children's Research Institute, Parkville, Victoria, Australia. AD - Department of Pediatrics, The University of Melbourne, Parkville, Victoria, Australia. FAU - Chokephaibulkit, Kulkanya AU - Chokephaibulkit K AUID- ORCID: 0000-0002-0140-4600 AD - Siriraj Institute of Clinical Research (SICRES), Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. AD - Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20230713 PL - United States TA - Hum Vaccin Immunother JT - Human vaccines & immunotherapeutics JID - 101572652 RN - 0 (Antibodies, Viral) RN - 0 (BNT162 Vaccine) RN - 0 (COVID-19 Vaccines) RN - 0 (Immunoglobulin G) RN - 0 (sinovac COVID-19 vaccine) SB - IM CIN - Hum Vaccin Immunother. 2023 Aug 1;19(2):2245694. PMID: 37650290 MH - Adolescent MH - Adult MH - Female MH - Humans MH - Infant MH - Middle Aged MH - Pregnancy MH - Young Adult MH - Antibodies, Viral MH - BNT162 Vaccine MH - *COVID-19/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - Immunogenicity, Vaccine MH - Immunoglobulin G MH - *Pregnancy Complications, Infectious/prevention & control MH - Pregnant Women MH - Vaccination PMC - PMC10406153 OTO - NOTNLM OT - BNT162b2 OT - ChAdOx1 OT - CoronaVac OT - Heterologous schedules OT - Homologous schedules OT - Thailand COIS- No potential conflicts of interest were reported by the authors. EDAT- 2023/07/13 12:31 MHDA- 2023/07/21 06:44 PMCR- 2023/07/13 CRDT- 2023/07/13 10:43 PHST- 2023/07/21 06:44 [medline] PHST- 2023/07/13 12:31 [pubmed] PHST- 2023/07/13 10:43 [entrez] PHST- 2023/07/13 00:00 [pmc-release] AID - 2228670 [pii] AID - 10.1080/21645515.2023.2228670 [doi] PST - ppublish SO - Hum Vaccin Immunother. 2023 Aug 1;19(2):2228670. doi: 10.1080/21645515.2023.2228670. Epub 2023 Jul 13.