Evidence map›Paper›PMID 35665745›Full record

Trial reportSignal transduction and targeted therapy2022

Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV: a phase 2 trial.

Nawal Al Kaabi, Yun Kai Yang, Jing Zhang, Ke Xu, Yu Liang, Yun Kang, Ji Guo Su, Tian Yang, Salah Hussein, Mohamed Saif ElDein and 28 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Signal transduction and targeted therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.1field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 31 citations in OpenAlex.

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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

38 authors at 7 institutions in 2 countries.

Nawal Al Kaabi *Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates.
Yun Kai Yang *China National Biotec Group Company Limited, Beijing, China.
Jing Zhang *The Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Ke Xu *National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
Yu LiangThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Yun KangThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Ji Guo SuThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Tian YangChina National Biotec Group Company Limited, Beijing, China.
Salah HusseinSheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates.
Mohamed Saif ElDeinSheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates.
Shuai ShaoThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Sen Sen YangThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Wenwen LeiNational Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
Xue Jun GaoLanzhou Institute of Biological Products Company Limited, Lanzhou, China.
Zhiwei JiangBeijing Key Tech Statistical Consulting Co., Ltd, Beijing, China.
Hui WangBeijing Institute of Biological Products Company Limited, Beijing, China.
Meng LiChina National Biotec Group Company Limited, Beijing, China.
Hanadi Mekki MekkiUnion 71, Abu Dhabi, United Arab Emirates.
Walid ZaherG42 Healthcare, Abu Dhabi, United Arab Emirates.
Sally MahmoudG42 Healthcare, Abu Dhabi, United Arab Emirates.ORCID 0000-0003-1348-9063
Xue ZhangChina National Biotec Group Company Limited, Beijing, China.
Chang QuChina National Biotec Group Company Limited, Beijing, China.
Dan Ying LiuChina National Biotec Group Company Limited, Beijing, China.
Jing ZhangNational Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
Mengjie YangNational Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China.
Islam EltantawyG42 Healthcare, Abu Dhabi, United Arab Emirates.
Peng XiaoG42 Healthcare, Abu Dhabi, United Arab Emirates.
Zhao Nian WangChina National Biotec Group Company Limited, Beijing, China.
Jin Liang YinChina National Biotec Group Company Limited, Beijing, China.
Xiao Yan MaoLanzhou Institute of Biological Products Company Limited, Lanzhou, China.
Jin ZhangBeijing Institute of Biological Products Company Limited, Beijing, China.
Ning LiuThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Fu Jie ShenThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Liang QuChina National Biotec Group Company Limited, Beijing, China.
Yun Tao ZhangChina National Biotec Group Company Limited, Beijing, China. zhangyuntao@sinopharm.com.
Xiao Ming YangChina National Biotec Group Company Limited, Beijing, China. yangxiaoming@sinopharm.com.ORCID 0000-0002-2598-4355
Guizhen WuNational Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC), Beijing, China. wugz@ivdc.chinacdc.cn.
Qi Ming LiThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China. liqiming189@163.com.ORCID 0000-0001-8284-7106
National Vaccine and Serum Institute · CNChinese Center For Disease Control and Prevention · CNChina National Pharmaceutical Group Corporation (China) · CNLanzhou Institute of Husbandry and Pharmaceutical Sciences · CNShaikh Khalifa Medical City · AEEmirates Foundation · AEKhalifa University of Science and Technology · AE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The increased coronavirus disease 2019 (COVID-19) breakthrough cases pose the need of booster vaccination. We conducted a randomised, double-blinded, controlled, phase 2 trial to assess the immunogenicity and safety of the heterologous prime-boost vaccination with an inactivated COVID-19 vaccine (BBIBP-CorV) followed by a recombinant protein-based vaccine (NVSI-06-07), using homologous boost with BBIBP-CorV as control. Three groups of healthy adults (600 individuals per group) who had completed two-dose BBIBP-CorV vaccinations 1-3 months, 4-6 months and ≥6 months earlier, respectively, were randomly assigned in a 1:1 ratio to receive either NVSI-06-07 or BBIBP-CorV boost. Immunogenicity assays showed that in NVSI-06-07 groups, neutralizing antibody geometric mean titers (GMTs) against the prototype SARS-CoV-2 increased by 21.01-63.85 folds on day 28 after vaccination, whereas only 4.20-16.78 folds of increases were observed in control groups. For Omicron variant, the neutralizing antibody GMT elicited by homologous boost was 37.91 on day 14, however, a significantly higher neutralizing GMT of 292.53 was induced by heterologous booster. Similar results were obtained for other SARS-CoV-2 variants of concerns (VOCs), including Alpha, Beta and Delta. Both heterologous and homologous boosters have a good safety profile. Local and systemic adverse reactions were absent, mild or moderate in most participants, and the overall safety was quite similar between two booster schemes. Our findings indicated that NVSI-06-07 is safe and immunogenic as a heterologous booster in BBIBP-CorV recipients and was immunogenically superior to the homologous booster against not only SARS-CoV-2 prototype strain but also VOCs, including Omicron.

Indexed as

COVID-19COVID-19 VaccinesImmunization, SecondaryAdultAntibodies, NeutralizingAntibodies, ViralHumansSARS-CoV-2Antibodies, NeutralizingAntibodies, ViralCOVID-19 Vaccines

Identifiers

PMID35665745
PMCPMC9167817
OpenAlexW4281773007

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.