Evidence map›Paper›PMID 32450106›Full record

ArticleLancet (London, England)2020

Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial.

Feng-Cai Zhu, Yu-Hua Li, Xu-Hua Guan, Li-Hua Hou, Wen-Juan Wang, Jing-Xin Li, Shi-Po Wu, Bu-Sen Wang, Zhao Wang, Lei Wang and 11 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Lancet (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04944095 (Serology Testing), which is not on this map. Cited by 851 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
851citing papers in PubMed, 2 pooled it
32.6field-weighted citation impact, top 1% 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.

NCT04944095 unknown statusnot on this mapstarted 2021, after this paper: background citation

Serology Testing (Antibody Levels) With Time Following SARS-CoV-2 (Covid-19) Vaccinations in Residents of Nursing, Extended Care, and Over-55 Communities

TypeobservationalSponsorDr. Sidney J. StohsRan2021 to 2024Enrolled10,000ConditionsCovid-19, Subjects Vaccinated Against Covid-19ArmsChange in SARS-CoV-2 Antibody Levels
3 · Its place in the literature

Who cites it

851 citing papers in PubMed, 2 syntheses or guidelines pooled it, 1,450 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Review
  12. The immunogenicity and safety of adenoviral-based vaccines.Current opinion in allergy and clinical immunology · 2026
    Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review

791 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 6 institutions in 1 country.

Feng-Cai ZhuNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. Electronic address: jszfc@vip.sina.com.
Yu-Hua LiChina National Institute for Food and Drug Control, Beijing, China.
Xu-Hua GuanHubei Provincial Center for Disease Control and Prevention, Wuhan, China.
Li-Hua HouBeijing Institute of Biotechnology, Beijing, China.
Wen-Juan WangNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Jing-Xin LiNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Shi-Po WuBeijing Institute of Biotechnology, Beijing, China.
Bu-Sen WangBeijing Institute of Biotechnology, Beijing, China.
Zhao WangHubei Provincial Center for Disease Control and Prevention, Wuhan, China.
Lei WangHubei Provincial Center for Disease Control and Prevention, Wuhan, China.
Si-Yue JiaNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Hu-Dachuan JiangNHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Ling WangChina National Institute for Food and Drug Control, Beijing, China.
Tao JiangBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.
Yi HuBeijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.
Jin-Bo GouCanSino Biologics, Tianjin, China.
Sha-Bei XuClinical Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jun-Jie XuBeijing Institute of Biotechnology, Beijing, China.
Xue-Wen WangShanghai Canming Medical Technology, Shanghai, China.
Wei WangClinical Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: wwang@vip.126.com.
Wei ChenBeijing Institute of Biotechnology, Beijing, China. Electronic address: cw0226@foxmail.com.
Jiangsu Provincial Center for Disease Control and Prevention · CNHubei Provincial Center for Disease Control and Prevention · CNInstitute of Microbiology · CNNational Institutes for Food and Drug Control · CNCanSino (China) · CNHuazhong University of Science and Technology · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.

methodsWe did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 10

findingsBetween March 16 and March 27, 2020, we screened 195 individuals for eligibility. Of them, 108 participants (51% male, 49% female; mean age 36·3 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%) participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination.

interpretationThe Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.

fundingNational Key R&D Program of China, National Science and Technology Major Project, and CanSino Biologics.

Indexed as

AdenoviridaeAdolescentAdultAntibodies, NeutralizingAntibodies, ViralBetacoronavirusChinaCoronavirus InfectionsCOVID-19COVID-19 VaccinesEnzyme-Linked Immunosorbent AssayFemaleHumansImmunity, CellularImmunity, HumoralInjections, IntramuscularAd5-nCoV vaccineAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesVaccines, SyntheticViral Vaccines

Identifiers

PMID32450106
PMCPMC7255193
OpenAlexW3027138240

What OpenQuestion holds

Textmetadata
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.