Evidence map›Paper›PMID 38400158›Full record

ArticleVaccines2024

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

Jihai Tang, Qinghua Xu, Chaoyin Zhu, Kun Xuan, Tao Li, Qingru Li, Xingya Pang, Zhenqiu Zha, Jinwei Li, Liyang Qiao and 9 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05933512 (A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-2), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05933512 phase2unknown statusnot on this map

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-2 (COVID-19 Beta/Omicron (BA.1/BQ.1.1/XBB.1) Variants S-Trimer Vaccine) in Population Previously Vaccinated With mRNA COVID-19 Vaccine

TypeinterventionalSponsorSinocelltech Ltd.Ran2023 to 2024Enrolled600ConditionsCOVID-19, SARS-CoV-2 InfectionArmsSCTV01E-2, SCTV01E
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 5 institutions in 1 country.

Jihai TangAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, China.ORCID 0000-0002-9776-6699
Qinghua XuAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, China.
Chaoyin ZhuFunan County Center for Disease Control and Prevention, Fuyang 236399, China.
Kun XuanAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, China.ORCID 0000-0002-8867-9577
Tao LiAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, China.
Qingru LiAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, China.
Xingya PangAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, China.
Zhenqiu ZhaAnhui Provincial Center for Disease Control and Prevention, Public Health Research Institute of Anhui Province, Hefei 230601, China.
Jinwei LiFuyang Center for Disease Control and Prevention, Fuyang 236030, China.
Liyang QiaoFunan County Center for Disease Control and Prevention, Fuyang 236399, China.
Haiyang XuFuyang Center for Disease Control and Prevention, Fuyang 236030, China.
Gang WuFunan County Center for Disease Control and Prevention, Fuyang 236399, China.
Yan TianFunan County Center for Disease Control and Prevention, Fuyang 236399, China.
Jun HanState Key Laboratory of Infectious, Disease Prevention and Control, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.ORCID 0000-0002-0803-4403
Cuige GaoBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China.
Jiang YiBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China.
Gui QianBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China.
Xuxin TianBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China.
Liangzhi XieBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing 100176, China.ORCID 0000-0003-4504-7622
Anhui Provincial Center for Disease Control and Prevention · CNSinocelltech Group (China) · CNXian Center for Disease Control and Prevention · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNNational Institute for Viral Disease Control and Prevention · CN

Funding

Beijing Science and Technology Planning Project Z231100004823003National Key Research and Development Program of China 2022YFC0870600National Key Research and Development Program of China 2023YFC3042100
6 · The paper itself

Abstract

The Omicron EG.5 lineage of SARS-CoV-2 is currently on a trajectory to become the dominant strain. This phase 2 study aims to evaluate the immunogenicity of SCTV01E-2, a tetravalent protein vaccine, with a specific emphasis on its immunogenicity against Omicron EG.5, comparing it with its progenitor vaccine, SCTV01E (NCT05933512). As of 12 September 2023, 429 participants aged ≥18 years were randomized into the groups SCTV01E (N = 215) and SCTV01E-2 (N = 214). 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 the 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 than in the SCTV01E group. Additionally, SCTV01E and SCTV01E-2 induced a 5.5-fold and a 5.9-fold increase in nAb against XBB.1, respectively. Reactogenicity was generally mild and transient. No vaccine-related serious adverse events (SAEs), adverse events of special interest (AESIs), or deaths were reported. In summary, SCTV01E-2 elicited robust neutralizing responses against Omicron EG.5 and XBB.1 without raising safety concerns, highlighting its potential as a versatile COVID-19 vaccine against SARS-CoV-2 variants.

Indexed as

boosterimmunogenicitymultivalent vaccinesafetySARS-CoV-2

Identifiers

PMID38400158
PMCPMC10893468
OpenAlexW4391643116

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.