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Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial.
Kaabi, Nawal Al; Yang, Yun Kai; Du, Li Fang; Xu, Ke; Shao, Shuai; Liang, Yu; Kang, Yun; Su, Ji Guo; Zhang, Jing; Yang, Tian; Hussein, Salah; ElDein, Mohamed Saif; Yang, Sen Sen; Lei, Wenwen; Gao, Xue Jun; Jiang, Zhiwei; Cong, Xiangfeng; Tan, Yao; Wang, Hui; Li, Meng; Mekki, Hanadi Mekki; Zaher, Walid; Mahmoud, Sally; Zhang, Xue; Qu, Chang; Liu, Dan Ying; Zhang, Jing; Yang, Mengjie; Eltantawy, Islam; Hou, Jun Wei; Lei, Ze Hua; Xiao, Peng; Wang, Zhao Nian; Yin, Jin Liang; Mao, Xiao Yan; Zhang, Jin; Qu, Liang; Zhang, Yun Tao; Yang, Xiao Ming; Wu, Guizhen; Li, Qi Ming.
  • Kaabi NA; Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates.
  • Yang YK; College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates.
  • Du LF; China National Biotec Group Company Limited, Beijing, China.
  • Xu K; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Shao S; National Engineering Center for New Vaccine Research, Beijing, China.
  • Liang Y; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
  • Kang Y; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Su JG; National Engineering Center for New Vaccine Research, Beijing, China.
  • Zhang J; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Yang T; National Engineering Center for New Vaccine Research, Beijing, China.
  • Hussein S; National Engineering Center for New Vaccine Research, Beijing, China.
  • ElDein MS; Clinical Medicine Office, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Yang SS; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Lei W; National Engineering Center for New Vaccine Research, Beijing, China.
  • Gao XJ; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Jiang Z; National Engineering Center for New Vaccine Research, Beijing, China.
  • Cong X; China National Biotec Group Company Limited, Beijing, China.
  • Tan Y; Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates.
  • Wang H; Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates.
  • Li M; National Engineering Center for New Vaccine Research, Beijing, China.
  • Mekki HM; Clinical Medicine Office, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Zaher W; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
  • Mahmoud S; Lanzhou Institute of Biological Products Company Limited, Lanzhou, China.
  • Zhang X; Beijing Key Tech Statistical Consulting Co., Ltd, Beijing, China.
  • Qu C; National Engineering Center for New Vaccine Research, Beijing, China.
  • Liu DY; Clinical Medicine Office, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Zhang J; National Engineering Center for New Vaccine Research, Beijing, China.
  • Yang M; Clinical Medicine Office, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Eltantawy I; Beijing Institute of Biological Products Company Limited, Beijing, China.
  • Hou JW; China National Biotec Group Company Limited, Beijing, China.
  • Lei ZH; Union 71, Abu Dhabi, United Arab Emirates.
  • Xiao P; G42 Healthcare, Abu Dhabi, United Arab Emirates.
  • Wang ZN; G42 Healthcare, Abu Dhabi, United Arab Emirates.
  • Yin JL; China National Biotec Group Company Limited, Beijing, China.
  • Mao XY; China National Biotec Group Company Limited, Beijing, China.
  • Zhang J; China National Biotec Group Company Limited, Beijing, China.
  • Qu L; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
  • Zhang YT; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
  • Yang XM; G42 Healthcare, Abu Dhabi, United Arab Emirates.
  • Wu G; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
  • Li QM; National Engineering Center for New Vaccine Research, Beijing, China.
Nat Commun ; 13(1): 3654, 2022 06 27.
Article in English | MEDLINE | ID: covidwho-1908175
ABSTRACT
NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluate the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in BBIBP-CorV recipients in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who have administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, are randomized 11 to receive either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The incidence of adverse reactions is low, and the overall safety profile is quite similar between two booster regimens. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster are significantly higher than those by BBIBP-CorV booster against not only SARS-CoV-2 prototype strain but also multiple variants of concerns (VOCs). Especially, the neutralizing antibody GMT against Omicron variant induced by heterologous NVSI-06-08 booster reaches 367.67, which is substantially greater than that boosted by BBIBP-CorV (GMT 45.03). In summary, NVSI-06-08 is safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which is immunogenically superior to the homologous boost with another dose of BBIBP-CorV.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Observational study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2022 Document Type: Article Affiliation country: S41467-022-31379-0

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Observational study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2022 Document Type: Article Affiliation country: S41467-022-31379-0