Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial

Nawal Al Kaabi(Khalifa University of Science and Technology), Yun Yang, Li Fang Du(National Vaccine and Serum Institute), Ke Xu(Chinese Center For Disease Control and Prevention), Shuai Shao(National Vaccine and Serum Institute), Yu Liang(National Vaccine and Serum Institute), Yun Kang(National Vaccine and Serum Institute), Ji Guo Su(National Vaccine and Serum Institute), Jing Zhang(Chinese Center For Disease Control and Prevention), Tian Yang, Salah Eldin Hussein(Shaikh Khalifa Medical City), Mohamed Saif ElDein(Shaikh Khalifa Medical City), Sen Yang(National Vaccine and Serum Institute), Wenwen Lei(Chinese Center For Disease Control and Prevention), Xue Gao(Lanzhou Institute of Husbandry and Pharmaceutical Sciences), Zhiwei Jiang, Xiangfeng Cong(National Vaccine and Serum Institute), Yao Tan(National Vaccine and Serum Institute), Hui Wang(National Vaccine and Serum Institute), Meng Li, Hanadi Mekki Mekki(Emirates Foundation), Walid Zaher, Sally Mahmoud, Xue Zhang, Chang Qu, Dan Ying Liu, Jing Zhang(Chinese Center For Disease Control and Prevention), Mengjie Yang(Chinese Center For Disease Control and Prevention), Islam Eltantawy, Jun Hou(National Vaccine and Serum Institute), Ze Hua Lei(National Vaccine and Serum Institute), Peng Xiao, Zhao Nian Wang, Jin Liang Yin, Xiao Yan Mao(Lanzhou Institute of Husbandry and Pharmaceutical Sciences), Jin Zhang(Chinese Center For Disease Control and Prevention), Liang Qu, Yun Tao Zhang(China National Pharmaceutical Group Corporation (China)), Xiao Ming Yang(China National Pharmaceutical Group Corporation (China)), Guizhen Wu(Chinese Center For Disease Control and Prevention), Qi Ming Li(National Vaccine and Serum Institute)
Nature Communications
June 27, 2022
10.1038/s41467-022-31379-0
Cited by 45Open Access
Full Text

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 1:1 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.

Related Papers

Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection
David S. Khoury, Deborah Cromer, Arnold Reynaldi et al.|Nature Medicine|2021|4.2k
Striking antibody evasion manifested by the Omicron variant of SARS-CoV-2
Lihong Liu, Sho Iketani, Yicheng Guo et al.|Nature|2021|1.4k
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
Shengli Xia, Yuntao Zhang, Yanxia Wang et al.|The Lancet Infectious Diseases|2020|1.2k
Omicron extensively but incompletely escapes Pfizer BNT162b2 neutralization
Sandile Cele, Laurelle Jackson, David S. Khoury et al.|Nature|2021|1.2k
Evidence for antibody as a protective correlate for COVID-19 vaccines
Kristen Earle, Donna M. Ambrosino, Andrew Fioré-Gartland et al.|Vaccine|2021|977