Evidence map›Paper›PMID 38038866›Full record

ArticleInfectious diseases and therapy2023

Safety and Immunogenicity of Homologous Recombinant Adenovirus Type 5-Vectored COVID-19 Vaccine Booster Dose in Healthy Adults Aged 18-60 Years: a Single-Center, Open-Label Trial.

Siyue Jia, Jinlong Zhang, Xue Wang, Zhe Zhang, Busen Wang, Jun Zhang, Hudachuan Jiang, Ge Guo, Ying Wang, Jingxuan Wan and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04568811 (The Single-center, Open-label Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine in Healthy Adults Aged 18-60 Years), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 19% 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.

NCT04568811 phase1completednot on this map

The Single-center, Open-label Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine in Healthy Adults Aged 18-60 Years

TypeinterventionalSponsorJiangsu Province Centers for Disease Control and PreventionRan2020 to 2021Enrolled89ConditionsAdenovirus Type-5 Vectored COVID-19 VaccineArmsAdenovirus Type-5 Vectored COVID-19 Vaccine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
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

13 authors at 4 institutions in 2 countries.

Siyue Jia *NHC Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, China.
Jinlong Zhang *Beijing Institute of Biotechnology, Beijing, China.
Xue Wang *CanSino Biologics, Tianjin, China.
Zhe ZhangBeijing Institute of Biotechnology, Beijing, China.
Busen WangBeijing Institute of Biotechnology, Beijing, China.
Jun ZhangBeijing Institute of Biotechnology, Beijing, China.
Hudachuan JiangNHC Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, China.
Ge GuoCanSino Biologics, Tianjin, China.
Ying WangCanSino Biologics, Tianjin, China.
Jingxuan WanCanSino Biologics, Tianjin, China.
Wenjuan WangNHC Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, China. wangwj@jscdc.cn.
Lihua HouBeijing Institute of Biotechnology, Beijing, China. houlihua@sina.com.
Fengcai ZhuNHC Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, China. jszfc@vip.sina.com.
CanSino (China) · CNJiangsu Provincial Center for Disease Control and Prevention · CNCzech Academy of Sciences, Institute of Biotechnology · CZNanjing Medical University · CN

Funding

National Key R&D Program of China 2020YFC10841400National Science and Technology Major Project 2016ZX10004001National Science and Technology Major Project 2018ZX09201005
6 · The paper itself

Abstract

introductionThe waning antibody levels several months after prime vaccination and the persistent epidemics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) around the world have generated great interest in the evaluation of a booster dose. We aimed to assess the safety and immunogenicity of a homologous booster dose of the recombinant adenovirus type 5-vectored coronavirus disease 2019 (COVID-19) vaccine (Ad5-nCoV).

methodsIn this trial, we recruited healthy adults aged 18-60 years who had received one dose of Ad5-nCoV vaccine (low, middle, or high dose) in the previous phase 1 trial approximately 6 months earlier, and then all participants received a booster dose of 5 × 10

resultsFrom September 26 to 28, 2020, 108 volunteers were recruited and 89 eligible participants (52% male) were enrolled and received a booster dose of Ad5-nCoV vaccine: 28 (31%) had received a low prime dose, 30 (34%) a middle prime dose, and 31 (35%) a high prime dose in the previous phase 1 trial. All participants were included in the safety analysis and immunogenicity was assessed in 88 (99%) participants. Twenty-three (82%) participants in the low prime dose group, 23 (77%) participants in the middle prime dose group, and 26 (84%) participants in the high prime dose group reported at least one adverse reaction within the first 14 days post booster. Pain at the injection site and fatigue were the most common adverse reactions. Most adverse reactions were mild or moderate in all groups and no vaccine-related severe adverse event was noted within 12 months after booster vaccination. Neutralizing antibodies increased moderately at day 14 and peaked at 28 days post booster. T cell responses were also boosted at 14 days after vaccination.

conclusionsA homologous booster of Ad5-nCoV vaccine is well tolerated and immunogenic in healthy adults aged 18-60 years who had received a priming dose of Ad5-nCoV 6 months previously. The neutralizing antibodies against SARS-CoV-2 peaked at day 28 and specific T cell responses were noted at day 14 after booster. Ad5-nCoV vaccine can be considered as a homologous booster 6 months after a priming dose.

trial registrationClinicalTrials.gov, NCT04568811.

Indexed as

Adenovirus-vectored vaccineHomologous boosterSASR-CoV-2

Identifiers

PMID38038866
PMCPMC10746682
OpenAlexW4389244711

What OpenQuestion holds

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LicenceCC BY-NC
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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.