Your browser doesn't support javascript.
Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients: a randomized controlled phase 2 trial
Nawal Al Kaabi; Yun Kai Yang; Li Fang Du; Ke Xu; Shuai Shao; Yu Liang; Yun Kang; Ji Guo Su; Jing Zhang; Tian Yang; Salah Hussein; Mohamed Saif ElDein; Sen Sen Yang; Wenwen Lei; Xue Jun Gao; Zhiwei Jiang; Xiangfeng Cong; Yao Tan; Hui Wang; Meng Li; Hanadi Mekki Mekki; Walid Zaher; Sally Mahmoud; Xue Zhang; Chang Qu; Dan Ying Liu; Jing Zhang; Mengjie Yang; Islam Eltantawy; Jun Wei Hou; Ze Hua Lei; Peng Xiao; Zhao Nian Wang; Jin Liang Yin; Xiao Yan Mao; Jin Zhang; Liang Qu; Yun Tao Zhang; Xiao Ming Yang; Guizhen Wu; Qi Ming Li.
  • Nawal Al Kaabi; Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates
  • Yun Kai Yang; China National Biotec Group Company Limited, Beijing, China
  • Li Fang Du; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Ke Xu; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China
  • Shuai Shao; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Yu Liang; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Yun Kang; Clinical Medicine Office, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Ji Guo Su; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Jing Zhang; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Tian Yang; China National Biotec Group Company Limited, Beijing, China
  • Salah Hussein; Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates
  • Mohamed Saif ElDein; Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates
  • Sen Sen Yang; Clinical Medicine Office, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Wenwen Lei; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China
  • Xue Jun Gao; Lanzhou Institute of Biological Products Company Limited, Lanzhou, China
  • Zhiwei Jiang; Beijing Key Tech Statistical Consulting Co.,Ltd, Beijing, China
  • Xiangfeng Cong; Clinical Medicine Office, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Yao Tan; Clinical Medicine Office, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Hui Wang; Beijing Institute of Biological Products Company Limited, Beijing, China
  • Meng Li; China National Biotec Group Company Limited, Beijing, China
  • Hanadi Mekki Mekki; Union 71, United Arab Emirates
  • Walid Zaher; G42 Healthcare, United Arab Emirates
  • Sally Mahmoud; G42 Healthcare, United Arab Emirates
  • Xue Zhang; China National Biotec Group Company Limited, Beijing, China
  • Chang Qu; China National Biotec Group Company Limited, Beijing, China
  • Dan Ying Liu; China National Biotec Group Company Limited, Beijing, China
  • Jing Zhang; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China
  • Mengjie Yang; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China
  • Islam Eltantawy; G42 Healthcare, United Arab Emirates
  • Jun Wei Hou; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Ze Hua Lei; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China
  • Peng Xiao; G42 Healthcare, United Arab Emirates
  • Zhao Nian Wang; China National Biotec Group Company Limited, Beijing, China
  • Jin Liang Yin; China National Biotec Group Company Limited, Beijing, China
  • Xiao Yan Mao; Lanzhou Institute of Biological Products Company Limited, Lanzhou, China
  • Jin Zhang; Beijing Institute of Biological Products Company Limited, Beijing, China
  • Liang Qu; China National Biotec Group Company Limited, Beijing, China
  • Yun Tao Zhang; China National Biotec Group Company Limited, Beijing, China
  • Xiao Ming Yang; China National Biotec Group Company Limited, Beijing, China
  • Guizhen Wu; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China
  • Qi Ming Li; The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China
Preprint in English | medRxiv | ID: ppmedrxiv-22272062
ABSTRACT
The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants with immune escape ability raises the urgent need for developing cross-neutralizing vaccines against the virus. 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 evaluated the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in adults previously vaccinated with the inactivated vaccine BBIBP-CorV 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 had administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, were vaccinated with either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The primary outcome was immunogenicity and safety of booster vaccinations. The exploratory outcome was cross-reactive immunogenicity against multiple SARS-CoV-2 variants of concerns (VOCs). The incidence of adverse reactions was low in both booster vaccinations, and the overall safety profile of heterologous boost was quite similar to that of homologous boost. Heterologous NVSI-06-08 booster was immunogenically superior to homologous booster of BBIBP-CorV. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster were significantly higher than by the booster of BBIBP-CorV against not only SARS-CoV-2 prototype strain but also multiple VOCs. Especially, the neutralizing activity induced by NVSI-06-08 booster against the immune-evasive Beta variant was no less than that against the prototype strain, and a considerable level of neutralizing antibodies against Omicron (GMT 367.67; 95%CI, 295.50-457.47) was induced by heterologous booster, which was substantially higher than that boosted by BBIBP-CorV (GMT 45.03; 95%CI, 36.37-55.74). Our findings showed that NVSI-06-08 was safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which was immunogenically superior to homologous boost with another dose of BBIBP-CorV. Our study also indicated that the design of hybrid antigen may provide an effective strategy for broad-spectrum vaccine developments.
Full text: Available Collection: Preprints Database: medRxiv Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Language: English Year: 2022 Document Type: Preprint

Similar

MEDLINE

...
LILACS

LIS

Full text: Available Collection: Preprints Database: medRxiv Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Language: English Year: 2022 Document Type: Preprint