PMID- 34197281 OWN - NLM STAT- MEDLINE DCOM- 20210819 LR - 20210819 IS - 2222-1751 (Electronic) IS - 2222-1751 (Linking) VI - 10 IP - 1 DP - 2021 Dec TI - Safety and immunogenicity of a recombinant interferon-armed RBD dimer vaccine (V-01) for COVID-19 in healthy adults: a randomized, double-blind, placebo-controlled, Phase I trial. PG - 1589-1597 LID - 10.1080/22221751.2021.1951126 [doi] AB - Safe and effective vaccines are still urgently needed to cope with the ongoing COVID-19 pandemic. Recently, we developed a recombinant COVID-19 vaccine (V-01) containing fusion protein (IFN-PADRE-RBD-Fc dimer) as antigen verified to induce protective immunity against SARS-CoV-2 challenge in pre-clinical study, which supported progression to Phase I clinical trials in humans. A Randomized, double-blind, placebo-controlled Phase I clinical trial was initiated at the Guangdong Provincial Center for Disease Control and Prevention (Gaozhou, China) in February 2021. Healthy adults aged between 18 and 59 years and over 60 years were sequentially enrolled and randomly allocated into three subgroups (1:1:1) either to receive the vaccine (10, 25, and 50 mug) or placebo (V-01: Placebo = 4:1) intramuscularly with a 21-day interval by a sentinel and dose escalation design. The data showed a promising safety profile with approximately 25% vaccine-related overall adverse events (AEs) within 30 days and no grade 3 or worse AEs. Besides, V-01 provoked rapid and strong immune responses, elicited substantially high-titre neutralizing antibodies and anti-RBD IgG peaked at day 35 or 49 after first dose, presented with encouraging immunogenicity at low dose (10 mug) subgroup and elderly participants, which showed great promise to be used as all-aged (18 and above) vaccine against COVID-19. Taken together, our preliminary findings indicate that V-01 is safe and well tolerated, capable of inducing rapid and strong immune responses, and warrants further testing in Phase II/III clinical trials. FAU - Zhang, Jikai AU - Zhang J AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, People's Republic of China. FAU - Hu, Zhongyu AU - Hu Z AD - National Institutes for Food and Drug Control, Beijing, People's Republic of China. FAU - He, Jianfeng AU - He J AD - Guangdong Provincial Center for Disease Control and Prevention, Guangzhou, People's Republic of China. FAU - Liao, Yuyi AU - Liao Y AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, People's Republic of China. FAU - Li, Yuan AU - Li Y AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, People's Republic of China. FAU - Pei, Rongjuan AU - Pei R AD - Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, People's Republic of China. FAU - Fang, Xin AU - Fang X AD - National Institutes for Food and Drug Control, Beijing, People's Republic of China. FAU - Zeng, Peiyu AU - Zeng P AD - Gaozhou Center for Disease Control and Prevention, Maoming, People's Republic of China. FAU - Fan, Renfeng AU - Fan R AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, People's Republic of China. FAU - Ou, Zhiqiang AU - Ou Z AD - Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, People's Republic of China. FAU - Deng, Jinglong AU - Deng J AD - Gaozhou Center for Disease Control and Prevention, Maoming, People's Republic of China. FAU - Zhou, Jian AU - Zhou J AD - Gaozhou Center for Disease Control and Prevention, Maoming, People's Republic of China. FAU - Guan, Wuxiang AU - Guan W AD - Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, People's Republic of China. FAU - Min, Yuanqin AU - Min Y AD - Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, People's Republic of China. FAU - Deng, Fei AU - Deng F AD - Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, People's Republic of China. FAU - Peng, Hua AU - Peng H AD - Key Laboratory of Infection and Immunity, Institute of Biophysics, Chinese Academy of Sciences, Beijing, People's Republic of China. FAU - Zhang, Zheng AU - Zhang Z AD - Institute for Hepatology, National Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, Shenzhen, People's Republic of China. FAU - Feng, Chunyan AU - Feng C AD - LivzonBio Inc., Zhuhai, People's Republic of China. FAU - Xin, Baobao AU - Xin B AD - LivzonBio Inc., Zhuhai, People's Republic of China. LA - eng PT - Clinical Trial, Phase I PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - Emerg Microbes Infect JT - Emerging microbes & infections JID - 101594885 RN - 0 (Antibodies, Neutralizing) RN - 0 (Antibodies, Viral) RN - 0 (COVID-19 Vaccines) RN - 0 (Immunoglobulin G) RN - 0 (Placebos) RN - 0 (Vaccines, Synthetic) RN - 9008-11-1 (Interferons) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Antibodies, Neutralizing/blood MH - Antibodies, Viral/*blood MH - COVID-19/*prevention & control MH - COVID-19 Vaccines/administration & dosage/adverse effects/*immunology MH - China MH - Double-Blind Method MH - Female MH - Humans MH - *Immunogenicity, Vaccine MH - Immunoglobulin G/blood MH - Interferons/administration & dosage/genetics/*immunology MH - Male MH - Middle Aged MH - Placebos MH - Vaccination/adverse effects MH - Vaccines, Synthetic/administration & dosage/immunology MH - Young Adult PMC - PMC8366678 OTO - NOTNLM OT - COVID-19 OT - Phase I OT - RBD dimer OT - clinical trial OT - elderly participants OT - immunogenicity OT - recombinant protein vaccine OT - safety COIS- Chunyan Feng and Baobao Xin are the employees of LivzonBio Inc. China. Other authors declare no competing interest. EDAT- 2021/07/02 06:00 MHDA- 2021/08/20 06:00 PMCR- 2021/08/12 CRDT- 2021/07/01 17:17 PHST- 2021/07/02 06:00 [pubmed] PHST- 2021/08/20 06:00 [medline] PHST- 2021/07/01 17:17 [entrez] PHST- 2021/08/12 00:00 [pmc-release] AID - 1951126 [pii] AID - 10.1080/22221751.2021.1951126 [doi] PST - ppublish SO - Emerg Microbes Infect. 2021 Dec;10(1):1589-1597. doi: 10.1080/22221751.2021.1951126.