Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Immunogenicity of Tetravalent Protein Vaccine, SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: a Phase 2 Trial

Jihai Tang
ORCID logo ,
Qinghua Xu
,
Chaoyin Zhu
,
Kun Xuan
ORCID logo ,
Tao Li
,
Qingru Li
,
Xingya Pang
,
Zhenqiu Zha
,
Jinwei Li
,
Liyang Qiao
,
Haiyang Xu
,
Gang Wu
,
Yan Tian
,
Jun Han
ORCID logo ,
Cuige Gao
,
Gui Qian
,
Xuxin Tian
,
Liangzhi Xie
* ORCID logo
Version 1 : Received: 13 December 2023 / Approved: 13 December 2023 / Online: 15 December 2023 (01:43:16 CET)

A peer-reviewed article of this Preprint also exists.

Tang, J.; Xu, Q.; Zhu, C.; Xuan, K.; Li, T.; Li, Q.; Pang, X.; Zha, Z.; Li, J.; Qiao, L.; Xu, H.; Wu, G.; Tian, Y.; Han, J.; Gao, C.; Yi, J.; Qian, G.; Tian, X.; Xie, L. Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial. Vaccines 2024, 12, 175. Tang, J.; Xu, Q.; Zhu, C.; Xuan, K.; Li, T.; Li, Q.; Pang, X.; Zha, Z.; Li, J.; Qiao, L.; Xu, H.; Wu, G.; Tian, Y.; Han, J.; Gao, C.; Yi, J.; Qian, G.; Tian, X.; Xie, L. Immunogenicity of Tetravalent Protein Vaccine SCTV01E-2 against SARS-CoV-2 EG.5 Subvaraint: A Phase 2 Trial. Vaccines 2024, 12, 175.

Abstract

The Omicron EG.5 lineage of SARS-CoV-2 is currently on a trajectory to become a dominant strain. This phase 2 study aims to evaluate the immunogenicity of SCTV01E-2, a tetravalent protein vaccine, with a specific emphasis on its effectiveness against Omicron EG.5, comparing it with its progenitor vaccine, SCTV01E (NCT05933512). As of September 12, 2023, 429 participants aged ≥18 years were randomized to SCTV01E (N=215) or SCTV01E-2 (N=214) groups. Both vaccines showed increases in neutralizing antibody (nAb) against Omicron EG.5, with a 5.7-fold increase and a 9.0-fold increase in SCTV01E and SCTV01E-2 groups 14 days post-vaccination, respectively. The predetermined statistical endpoints were achieved, showing that the geometric mean titer (GMT) of nAb and the seroresponse rate (SRR) against Omicron EG.5 were significantly higher in the SCTV01E-2 group compared to SCTV01E. Additionally, SCTV01E and SCTV01E-2 induced a 5.5-fold and a 5.9-fold increase of nAb against XBB.1, respectively. Reactogenicity was generally mild and transient. No vaccine related SAEs, AESIs or deaths were reported. In summary, SCTV01E-2 elicited robust neutralizing responses against Omicron EG.5 and XBB.1 without safety concerns, underlining its potential as a versatile COVID-19 vaccine against SARS-CoV-2 variants.

Keywords

Safety; Immunogenicity; SARS-CoV-2; Multivalent vaccine; Booster

Subject

Public Health and Healthcare, Public Health and Health Services

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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