Evidence map›Paper›PMID 35605625›Full record

Trial reportThe Lancet. Respiratory medicine2022

Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trial.

Jing-Xin Li, Shi-Po Wu, Xi-Ling Guo, Rong Tang, Bao-Ying Huang, Xiao-Qin Chen, Yin Chen, Li-Hua Hou, Jing-Xian Liu, Jin Zhong and 10 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Lancet. Respiratory medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 2 pooled it
18.4field-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.

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

92 citing papers in PubMed, 2 syntheses or guidelines pooled it, 168 citations in OpenAlex.

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32 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

20 authors at 6 institutions in 1 country.

Jing-Xin LiNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China; School of Public Health, Nanjing Medical University, Nanjing, China; Institute of Global Public Health and Emergency Pharmacy, China Pharmaceutical University, Nanjing, China.
Shi-Po WuBeijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.
Xi-Ling GuoNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Rong TangNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Bao-Ying HuangNHC Key Laboratory of Biosafety, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
Xiao-Qin ChenDonghai County Center for Disease Control and Prevention, Donghai, China.
Yin ChenNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Li-Hua HouBeijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.
Jing-Xian LiuNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Jin ZhongDonghai County Center for Disease Control and Prevention, Donghai, China.
Hong-Xing PanNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Feng-Juan ShiNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Xiao-Yu XuVazyme Biotech, Nanjing, China.
Zhuo-Pei LiSchool of Public Health, Nanjing Medical University, Nanjing, China.
Xiao-Yin ZhangSchool of Public Health, Southeast University, Nanjing, China.
Lun-Biao CuiNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Wen-Jie TanNHC Key Laboratory of Biosafety, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
Wei ChenBeijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China. Electronic address: cw0226@foxmail.com.
Feng-Cai ZhuNational Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China; School of Public Health, Nanjing Medical University, Nanjing, China; Institute of Global Public Health and Emergency Pharmacy, China Pharmaceutical University, Nanjing, China; School of Public Health, Southeast University, Nanjing, China. Electronic address: jszfc@vip.sina.com.
CanSino COVID-19 Study Group
Jiangsu Provincial Center for Disease Control and Prevention · CNAcademy of Military Medical Sciences · CNChina Pharmaceutical University · CNNational Institute for Viral Disease Control and Prevention · CNNanjing Medical University · CNSoutheast University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDue to waning immunity and protection against infection with SARS-CoV-2, a third dose of a homologous or heterologous COVID-19 vaccine has been proposed by health agencies for individuals who were previously primed with two doses of an inactivated COVID-19 vaccine.

methodsWe did a randomised, open-label, controlled trial to evaluate the safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in Chinese adults (≥18 years old) who had previously received two doses of an inactivated SARS-CoV-2 vaccine-Sinovac CoronaVac. Eligible participants were randomly assigned (1:1:1) to receive a heterologous booster vaccination with a low dose (1·0 × 10

findingsBetween Sept 14 and 16, 2021, 420 participants were enrolled: 140 (33%) participants per group. Adverse reactions were reported by 26 (19%) participants in the low dose group and 33 (24%) in the high dose group within 14 days after the booster vaccination, significantly less than the 54 (39%) participants in the CoronaVac group (p<0·0001). The low dose group had a serum NAb GMT of 744·4 (95% CI 520·1-1065·6) and the high dose group had a GMT of 714·1 (479·4-1063·7) 14 days after booster dose, significantly higher than the GMT in the CoronaVac group (78·5 [60·5-101·7]; p<0·0001).

interpretationWe found that a heterologous booster vaccine with an orally administered aerosolised Ad5-nCoV is safe and highly immunogenic in adults who have previously received two doses of CoronaVac as the primary series vaccination.

fundingNational Natural Science Foundation of China and Jiangsu Provincial Key Research and Development Program.

Indexed as

COVID-19COVID-19 VaccinesAdolescentAdultHumansResearchSARS-CoV-2VaccinationCOVID-19 Vaccines

Identifiers

PMID35605625
PMCPMC9122540
OpenAlexW4282928458

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 Socratic graph.