Evidence map›Paper›PMID 35760812›Full record

Trial reportNature communications2022

Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial.

Nawal Al Kaabi, Yun Kai Yang, Li Fang Du, Ke Xu, Shuai Shao, Yu Liang, Yun Kang, Ji Guo Su, Jing Zhang, Tian Yang and 31 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05069129 (A Randomized, Controlled Phase I and Sequential Study to Evaluate the Safety and Immunogenicity Following Immunization of GEN2-Recombinant COVID-19 Vaccine), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
4.6field-weighted citation impact, top 4% 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.

NCT05069129 phase1 / phase2unknown statusnot on this map

A Randomized, Controlled Phase I and Sequential Study to Evaluate the Safety and Immunogenicity Following Immunization of GEN2-Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above

TypeinterventionalSponsorNational Vaccine and Serum Institute, ChinaRan2021 to 2024Enrolled1,848ConditionsCOVID-19 Pneumonia, Coronavirus InfectionsArmsRecombinant COVID-19 Vaccine (CHO cell,NVSI-06-08), Inactivated COVID-19 vaccine (Vero cells), 3 doses Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 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

41 authors at 7 institutions in 2 countries.

Nawal Al Kaabi *Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates.ORCID 0000-0003-2180-4158
Yun Kai Yang *China National Biotec Group Company Limited, Beijing, China.
Li Fang Du *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.
Shuai ShaoThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Yu LiangThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Yun KangNational Engineering Center for New Vaccine Research, Beijing, China.
Ji Guo SuThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Jing ZhangThe 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.
Sen Sen YangNational Engineering Center for New Vaccine Research, 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.
Xiangfeng CongNational Engineering Center for New Vaccine Research, Beijing, China.
Yao TanNational Engineering Center for New Vaccine Research, 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.ORCID 0000-0002-5868-7568
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.
Jun Wei HouThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
Ze Hua LeiThe Sixth Laboratory, National Vaccine and Serum Institute (NVSI), Beijing, China.
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.
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.ORCID 0000-0003-2778-4290
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

NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluate the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in BBIBP-CorV recipients in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who have administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, are randomized 1:1 to receive either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The incidence of adverse reactions is low, and the overall safety profile is quite similar between two booster regimens. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster are significantly higher than those by BBIBP-CorV booster against not only SARS-CoV-2 prototype strain but also multiple variants of concerns (VOCs). Especially, the neutralizing antibody GMT against Omicron variant induced by heterologous NVSI-06-08 booster reaches 367.67, which is substantially greater than that boosted by BBIBP-CorV (GMT: 45.03). In summary, NVSI-06-08 is safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which is immunogenically superior to the homologous boost with another dose of BBIBP-CorV.

Indexed as

COVID-19COVID-19 VaccinesImmunization, SecondaryImmunogenicity, VaccineAdultAntibodies, NeutralizingAntibodies, ViralHumansImmunoglobulin GSARS-CoV-2Antibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesImmunoglobulin G

Identifiers

PMID35760812
PMCPMC9237056
OpenAlexW4283583528

What OpenQuestion holds

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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.