PMID- 37422518
OWN - NLM
STAT- MEDLINE
DCOM- 20230710
LR  - 20240111
IS  - 2041-1723 (Electronic)
IS  - 2041-1723 (Linking)
VI  - 14
IP  - 1
DP  - 2023 Jul 8
TI  - Safety and immunogenicity of a tetravalent and bivalent SARS-CoV-2 protein 
      booster vaccine in men.
PG  - 4043
LID - 10.1038/s41467-023-39766-x [doi]
LID - 4043
AB  - The safety and immunogenicity of a protein-based tetravalent vaccine SCTV01E that 
      contains spike protein ectodomain (S-ECD) of Alpha, Beta, Delta and Omicron BA.1 
      are assessed and compared with bivalent protein vaccine SCTV01C (Alpha and Beta 
      variants) and monovalent mRNA vaccine (NCT05323461). The primary endpoints are 
      the geometric mean titers (GMT) of live virus neutralizing antibodies (nAb) to 
      Delta (B.1.617.2) and Omicron BA.1 at day 28 post-injection. The secondary 
      endpoints include the safety, day 180 GMTs against Delta and Omicron BA.1, day 28 
      GMTs to BA.5, and seroresponse rates of neutralizing antibodies and T cell 
      responses at day 28 post-injection. 450 participants, comprising of 449 males and 
      1 female, with a median age (range) of 27 (18-62) years, are assigned to receive 
      one booster dose of BNT162b2, 20 microg SCTV01C or 30 microg SCTV01E and completed 4-week 
      follow-up. All SCTV01E related adverse events (AEs) are mild or moderate and no 
      Grade >/=3 AE, serious AE or new safety concerns are identified. Day 28 GMT of live 
      virus neutralizing antibodies and seroresponse against Omicron BA.1 and BA.5 with 
      SCTV01E are significantly higher than those with SCTV01C and BNT162b2. These data 
      indicate an overall neutralization superiority with tetravalent booster 
      immunization in men.
CI  - (c) 2023. The Author(s).
FAU - Hannawi, Suad
AU  - Hannawi S
AUID- ORCID: 0000-0002-5689-6710
AD  - Internal Medicine Department, Al Kuwait-Dubai (ALBaraha) Hospital, Dubai, United 
      Arab Emirates.
FAU - Saf Eldin, Linda
AU  - Saf Eldin L
AUID- ORCID: 0000-0002-7440-0774
AD  - General Surgery Department, Al Kuwait-Dubai (ALBaraha) Hospital, Dubai, United 
      Arab Emirates.
FAU - Abuquta, Alaa
AU  - Abuquta A
AUID- ORCID: 0000-0003-1621-0777
AD  - Internal Medicine Department, Al Kuwait-Dubai (ALBaraha) Hospital, Dubai, United 
      Arab Emirates.
FAU - Alamadi, Ahmad
AU  - Alamadi A
AD  - Ear, Nose and Throat Department (ENT), Al Kuwait-Dubai (ALBaraha) Hospital, 
      Dubai, United Arab Emirates.
FAU - Mahmoud, Sally A
AU  - Mahmoud SA
AUID- ORCID: 0000-0003-1348-9063
AD  - Biogenix labs, G42 Healthcare, Dubai, United Arab Emirates.
FAU - Hassan, Aala
AU  - Hassan A
AD  - Internal Medicine Department, Al Kuwait-Dubai (ALBaraha) Hospital, Dubai, United 
      Arab Emirates.
FAU - Xu, Shuping
AU  - Xu S
AD  - Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., 
      Beijing, China.
FAU - Li, Jian
AU  - Li J
AD  - Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., 
      Beijing, China.
FAU - Liu, Dongfang
AU  - Liu D
AD  - Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., 
      Beijing, China.
FAU - Baidoo, Adam Abdul Hakeem
AU  - Baidoo AAH
AD  - Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., 
      Beijing, China.
FAU - Ibrahim, Dima
AU  - Ibrahim D
AD  - Infectious Diseases Department, Burjeel Medical City, Abu Dhabi, United Arab 
      Emirates.
FAU - Alhaj, Mojtaba
AU  - Alhaj M
AD  - Research Department, Burjeel Medical City, Abu Dhabi, United Arab Emirates.
FAU - Chen, Yuanxin
AU  - Chen Y
AD  - Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., 
      Beijing, China.
FAU - Zhou, Qiang
AU  - Zhou Q
AD  - Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., 
      Beijing, China.
FAU - Xie, Liangzhi
AU  - Xie L
AUID- ORCID: 0000-0003-4504-7622
AD  - Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., 
      Beijing, China. LX@sinocelltech.com.
AD  - Cell Culture Engineering Center, Chinese Academy of Medical Sciences & Peking 
      Union Medical College, Beijing, China. LX@sinocelltech.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230708
PL  - England
TA  - Nat Commun
JT  - Nature communications
JID - 101528555
RN  - 0 (SCTV01C vaccine)
RN  - 0 (BNT162 Vaccine)
RN  - 0 (Antibodies, Blocking)
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - SARS-CoV-2 variants
SB  - IM
EIN - Nat Commun. 2024 Jan 8;15(1):369. PMID: 38191554
MH  - Male
MH  - Humans
MH  - Female
MH  - Infant
MH  - *BNT162 Vaccine
MH  - *COVID-19/prevention & control
MH  - SARS-CoV-2
MH  - Antibodies, Blocking
MH  - Antibodies, Neutralizing
MH  - Antibodies, Viral
PMC - PMC10329711
COIS- L.X. has ownership or potential stock option interests in the company. All other 
      authors declare no other conflicts of interest.
EDAT- 2023/07/09 01:07
MHDA- 2023/07/10 06:42
PMCR- 2023/07/08
CRDT- 2023/07/08 23:19
PHST- 2023/02/01 00:00 [received]
PHST- 2023/06/28 00:00 [accepted]
PHST- 2023/07/10 06:42 [medline]
PHST- 2023/07/09 01:07 [pubmed]
PHST- 2023/07/08 23:19 [entrez]
PHST- 2023/07/08 00:00 [pmc-release]
AID - 10.1038/s41467-023-39766-x [pii]
AID - 39766 [pii]
AID - 10.1038/s41467-023-39766-x [doi]
PST - epublish
SO  - Nat Commun. 2023 Jul 8;14(1):4043. doi: 10.1038/s41467-023-39766-x.