Evidence map›Paper›PMID 33888900›Full record

Trial reportNature medicine2021

Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study.

Jingxin Li, Aimin Hui, Xiang Zhang, Yumei Yang, Rong Tang, Huayue Ye, Ruiru Ji, Mei Lin, Zhongkui Zhu, Özlem Türeci and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04380701 (A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-19 Using Different Dosing Regimens in Healthy and Immunocompromised Adults), which is not on this map. Cited by 94 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 8 pooled it
–field-weighted citation impact
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.

NCT04380701 phase1 / phase2completednot on this map

A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-19 Using Different Dosing Regimens in Healthy and Immunocompromised Adults

TypeinterventionalSponsorBioNTech SERan2020 to 2022Enrolled512ConditionsInfections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse ReactionArmsBNT162a1, BNT162b1, BNT162b2, BNT162c2
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
  2. Efficacy and safety of COVID-19 vaccines.The Cochrane database of systematic reviews · 2022
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  4. Immunogenicity and Safety of the COVID-19 Vaccines Compared With Control in Healthy Adults: A Qualitative and Systematic Review.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2022
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34 more citing papers are in PubMed but not listed here.

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

22 authors.

Jingxin Li *NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Aimin Hui *Fosun Pharma, Boston, MA, USA. aimin.hui@fosunpharma.com.ORCID http://orcid.org/0000-0002-3688-1570
Xiang ZhangTaizhou City Center for Disease Control and Prevention, Taizhou, China.
Yumei YangFosun Pharma, Beijing, China.
Rong TangNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Huayue YeTaizhou Vaccine Clinical Research Center, Taizhou, China.
Ruiru JiFosun Pharma, Boston, MA, USA.
Mei LinTaizhou People's Hospital, Taizhou, China.
Zhongkui ZhuTaizhou City Center for Disease Control and Prevention, Taizhou, China.
Özlem TüreciBioNTech SE, Mainz, Germany.
Eleni LagkadinouBioNTech SE, Mainz, Germany.
Siyue JiaNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Hongxing PanNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Fuzhong PengTaizhou Vaccine Clinical Research Center, Taizhou, China.
Zhilong MaTaizhou City Center for Disease Control and Prevention, Taizhou, China.
Zhenggang WuTaizhou People's Hospital, Taizhou, China.
Xiling GuoNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Yunfeng ShiNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Alexander MuikBioNTech SE, Mainz, Germany.ORCID http://orcid.org/0000-0003-4561-2273
Uğur ŞahinBioNTech SE, Mainz, Germany.
Li ZhuTaizhou People's Hospital, Taizhou, China. tzheart@126.com.ORCID http://orcid.org/0000-0002-6804-5235
Fengcai ZhuNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. jszfc@vip.sina.com.ORCID http://orcid.org/0000-0002-1644-0006

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Here, we assess the preliminary safety, tolerability and immunogenicity data from an ongoing single-center (in Jiangsu province, China), parallel-group, double-blind phase 1 trial of the vaccine candidate BNT162b1 in 144 healthy SARS-CoV-2-naive Chinese participants. These participants are randomized 1:1:1 to receive prime and boost vaccinations of 10 µg or 30 µg BNT162b1 or placebo, given 21 d apart, with equal allocation of younger (aged 18-55 years) and older adults (aged 65-85 years) to each treatment group (ChiCTR2000034825). BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) and is one of several messenger RNA-based vaccine candidates under clinical investigation. Local reactions and systemic events were generally dose dependent, transient and mild to moderate. Fever was the only grade 3 adverse event. BNT162b1 induced robust interferon-γ T cell responses to a peptide pool including the RBD in both younger and older Chinese adults, and geometric mean neutralizing titers reached 2.1-fold (for younger participants) and 1.3-fold (for the older participants) that of a panel of COVID-19 convalescent human sera obtained at least 14 d after positive SARS-CoV-2 polymerase chain reaction test. In summary, BNT162b1 has an acceptable safety profile and produces high levels of humoral and T cell responses in an Asian population.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineChinaCOVID-19COVID-19 VaccinesFemaleHumansMaleMiddle AgedmRNA VaccinesPandemicsAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesmRNA VaccinesRNA, MessengerSpike Glycoprotein, Coronavirusspike glycoprotein, SARS-CoVVaccines, Synthetic

Identifiers

PMID33888900

What OpenQuestion holds

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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.