PMID- 38365482 OWN - NLM STAT- MEDLINE DCOM- 20240318 LR - 20240318 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 42 IP - 7 DP - 2024 Mar 7 TI - Safety and immunogenicity of the NVX-CoV2373 vaccine as a booster in adults previously vaccinated with the BBIBP-CorV vaccine. PG - 1777-1784 LID - S0264-410X(24)00196-8 [pii] LID - 10.1016/j.vaccine.2024.02.037 [doi] AB - This phase 3 observer-blind, randomized, controlled study was conducted in adults >/=18 years of age to assess the safety and immunogenicity of NVX-CoV2373 as a heterologous booster compared to BBIBP-CorV when utilized as a homologous booster. Approximately 1000 participants were randomly assigned in a 1:1 ratio to receive a single dose of NVX-CoV2373 or BBIBP-CorV after prior vaccination with 2 or 3 doses of BBIBP-CorV. Solicited adverse events (AEs) were collected for 7 days after vaccination. Unsolicited AEs were collected for 28 days following the booster dose and serious adverse and adverse events of special interest (AESI) were collected throughout the study. Anti-spike IgG and neutralizing antibodies against SARS-CoV-2 were measured at baseline, day 14, day 28, and day 180. The study achieved its primary non-inferiority endpoint and also demonstrated statistically higher neutralization responses when NVX-CoV2373 was utilized as a heterologous booster compared with BBIBP-CorV as a homologous booster. Both vaccines had an acceptably low reactogenicity profile, and no new safety concerns were found. Heterologous boosting with NVX-CoV2373 was a highly immunogenic and safe vaccine regimen in those previously vaccinated with BBIBP-CorV. CI - Copyright (c) 2024 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Toback, Seth AU - Toback S AD - Novavax Inc., 700 Quince Orchard Rd, Gaithersburg, MD 20878, United States. Electronic address: stoback@novavax.com. FAU - Marchese, Anthony M AU - Marchese AM AD - Novavax Inc., 700 Quince Orchard Rd, Gaithersburg, MD 20878, United States. Electronic address: amarchese@novavax.com. FAU - Warren, Brandy AU - Warren B AD - Novavax Inc., 700 Quince Orchard Rd, Gaithersburg, MD 20878, United States. Electronic address: bwarren@novavax.com. FAU - Ayman, Sondos AU - Ayman S AD - Insights Research Organization & Solutions (IROS), Building of Masdar M13 T Limited, SE 45_05, Plot C16, Khalifa City, Abu Dhabi, United Arab Emirates. Electronic address: sondos.ayman@iros.ai. FAU - Zarkovic, Senka AU - Zarkovic S AD - Insights Research Organization & Solutions (IROS), Building of Masdar M13 T Limited, SE 45_05, Plot C16, Khalifa City, Abu Dhabi, United Arab Emirates. Electronic address: senka.zarkovic@iros.ai. FAU - ElTantawy, Islam AU - ElTantawy I AD - Insights Research Organization & Solutions (IROS), Building of Masdar M13 T Limited, SE 45_05, Plot C16, Khalifa City, Abu Dhabi, United Arab Emirates. Electronic address: Islam.Eltantawy@iros.ai. FAU - Mallory, Raburn M AU - Mallory RM AD - Novavax Inc., 700 Quince Orchard Rd, Gaithersburg, MD 20878, United States. Electronic address: rmallory@novavax.com. FAU - Rousculp, Matthew AU - Rousculp M AD - Novavax Inc., 700 Quince Orchard Rd, Gaithersburg, MD 20878, United States. Electronic address: mrousculp@novavax.com. FAU - Almarzooqi, Fahed AU - Almarzooqi F AD - G42 Healthcare, 3(rd) Floor, 1B Building, Mohamed bin Zayed University of Artificial Intelligence, Masdar City, Abu Dhabi, United Arab Emirates. Electronic address: fahed.almarzooqi@g42.ai. FAU - Piechowski-Jozwiak, Bartlomiej AU - Piechowski-Jozwiak B AD - Cleveland Clinic Abu Dhabi, 59 Hamouda Bin Ali Al Dhaheri St - Al Maryah Island - Abu Dhabi Global Market Square, Abu Dhabi, United Arab Emirates. Electronic address: piechob@clevelandclinicabudhabi.ae. FAU - Bonilla, Maria-Fernanda AU - Bonilla MF AD - Cleveland Clinic Abu Dhabi, 59 Hamouda Bin Ali Al Dhaheri St - Al Maryah Island - Abu Dhabi Global Market Square, Abu Dhabi, United Arab Emirates. Electronic address: bonillm@clevelandclinicabudhabi.ae. FAU - Bakkour, Agyad Ebrahim AU - Bakkour AE AD - Sheikh Khalifa Medical City, SEHA, Al Karamah St - Al Manhal - Al Tibbiya, Abu Dhabi, United Arab Emirates. Electronic address: o-abakkour@seha.ae. FAU - Hussein, Salah Eldin AU - Hussein SE AD - Sheikh Khalifa Medical City, SEHA, Al Karamah St - Al Manhal - Al Tibbiya, Abu Dhabi, United Arab Emirates. Electronic address: sahussein@seha.ae. FAU - Al Kaabi, Nawal AU - Al Kaabi N AD - Sheikh Khalifa Medical City, SEHA, Al Karamah St - Al Manhal - Al Tibbiya, Abu Dhabi, United Arab Emirates; College of Medicine and Health Sciences, Khalifa University, Shakhbout Bin Sultan St - Hadbat Al Za'faranah - Zone 1, Abu Dhabi, United Arab Emirates. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial DEP - 20240215 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 2SCD8Q63PF (NVX-CoV2373 adjuvated lipid nanoparticle) RN - 0 (BIBP COVID-19 vaccine) RN - 0 (COVID-19 Vaccines) RN - 0 (Vaccines) RN - 0 (Antibodies, Neutralizing) RN - 0 (Antibodies, Viral) RN - 0 (Vaccines, Inactivated) SB - IM MH - Adult MH - Humans MH - *COVID-19 Vaccines/adverse effects MH - *Vaccines MH - Vaccination MH - Antibodies, Neutralizing MH - Immunogenicity, Vaccine MH - Antibodies, Viral MH - *Vaccines, Inactivated OTO - NOTNLM OT - BBIBP-CorV OT - Immunogenicity OT - NVX-CoV2373 OT - Safety OT - Vaccine COIS- Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [ST, AMM, BW, RM, and MR are employees and stockholders of Novavax, Inc. SA, SZ, IET, AEB, SEH, NAK, FA, BP-J, and M-FB have no disclosures to report]. EDAT- 2024/02/17 10:43 MHDA- 2024/03/18 06:44 CRDT- 2024/02/16 21:53 PHST- 2023/09/26 00:00 [received] PHST- 2024/02/01 00:00 [revised] PHST- 2024/02/10 00:00 [accepted] PHST- 2024/03/18 06:44 [medline] PHST- 2024/02/17 10:43 [pubmed] PHST- 2024/02/16 21:53 [entrez] AID - S0264-410X(24)00196-8 [pii] AID - 10.1016/j.vaccine.2024.02.037 [doi] PST - ppublish SO - Vaccine. 2024 Mar 7;42(7):1777-1784. doi: 10.1016/j.vaccine.2024.02.037. Epub 2024 Feb 15.