Evidence map›Paper›PMID 39482336›Full record

ArticleNPJ vaccines2024

Safety, efficacy and immunogenicity of aerosolized Ad5-nCoV COVID-19 vaccine in a non-inferiority randomized controlled trial.

Chun K Chew, Ruijie Wang, Sunita Bavanandan, Norliza Zainudin, Xiaoyuan Zhao, Sumeyya Ahmed, Damenthi Nair, Lihua Hou, Rosnawati Yahya, Shereen S Ch'ng and 25 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05517642 (Immunogenicity, Efficacy and Safety of Inhaled), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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.

NCT05517642 phase3completednot on this map

Immunogenicity, Efficacy and Safety of Inhaled (IH) Viral Vectored Vaccine (Convidecia, CanSino) as Second Booster Dose Against Emerging Variants of Concern (VOC) of SARS-CoV-2 to Prevent Breakthrough Infections. A Randomized Observer-blind Controlled Trial.

TypeinterventionalSponsorCanSino Biologics Inc.Ran2022 to 2023Enrolled540ConditionsCOVID-19ArmsRecombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH), mRNA vaccine BNT162b2 (Pfizer)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  5. 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

35 authors.

Chun K Chew *Centre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.ORCID http://orcid.org/0000-0002-7674-5143
Ruijie Wang *Clinical Operations Center, CanSino Biologics Inc., Tianjin, China.
Sunita BavanandanDepartment of Nephrology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Norliza ZainudinRheumatology Unit, Hospital Selayang, Selangor, Malaysia.
Xiaoyuan ZhaoClinical Operations Center, CanSino Biologics Inc., Tianjin, China.
Sumeyya AhmedClinical Operations Center, CanSino Biologics Inc., Tianjin, China.
Damenthi NairClinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang, Selangor, Malaysia.
Lihua HouBeijing Institute of Biotechnology, Beijing, China.
Rosnawati YahyaDepartment of Nephrology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Shereen S Ch'ngRheumatology Unit, Hospital Selayang, Selangor, Malaysia.
Lai H PangClinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang, Selangor, Malaysia.
Azrini Abdul AzizDepartment of Nephrology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Haitao HuangClinical Operations Center, CanSino Biologics Inc., Tianjin, China.
Reena RajasuriarImmunotherapeutcis Laboratory and Department of Medicine, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia.
Shipo WuBeijing Institute of Biotechnology, Beijing, China.
Zhe ZhangBeijing Institute of Biotechnology, Beijing, China.
Xuewen WangShanghai ImStat Medical Technology Co., Ltd., Shanghai, China.
Geok Y ChunCentre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.ORCID http://orcid.org/0000-0002-9733-1126
Aisyah Mohd NorziClinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang, Selangor, Malaysia.ORCID http://orcid.org/0009-0000-9814-1431
Kit Y CheahClinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang, Selangor, Malaysia.ORCID http://orcid.org/0000-0001-6397-5735
Yi L LeeClinical Research Ward, Centre for Clinical Trial, Institute for Clinical Research, Hospital Ampang, Selangor, Malaysia.
Wan H Wan MohamadDepartment of Nephrology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Mohamad R Mohd DinDepartment of Nephrology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Wan M R Wan Ahmad KamilDepartment of Nephrology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.
Min H TanDepartment of Nephrology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.ORCID http://orcid.org/0000-0003-2807-6421
Xiaoyu XuNanjing Vazyme Biotech Co., Ltd., Nanjing, China.
Lina WangClinical Operations Center, CanSino Biologics Inc., Tianjin, China.
Meixu YanClinical Operations Center, CanSino Biologics Inc., Tianjin, China.
Yusi LiuClinical Operations Center, CanSino Biologics Inc., Tianjin, China.ORCID http://orcid.org/0009-0008-4242-7690
Voon K ChinClinical Operations Center, CanSino Biologics Inc., Tianjin, China.
Jau S TeoClindata Consult Sdn Bhd, Petaling Jaya, Selangor, Malaysia.ORCID http://orcid.org/0000-0002-5413-0324
Teck O LimClin Research Private Enterprise, Petaling Jaya, Selangor, Malaysia.
Tao ZhuClinical Operations Center, CanSino Biologics Inc., Tianjin, China.
Jinbo GouClinical Operations Center, CanSino Biologics Inc., Tianjin, China. jinbo.gou@cansinotech.com.
Sharon S M NgCentre for Clinical Trial, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia. sharonng@moh.gov.my.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase 3, observer-blinded, non-inferiority randomized trial (ClinicalTrials.gov: NCT05517642), conducted from September 2022 to May 2023 at three Malaysian sites, involved 540 adults previously vaccinated with three COVID-19 doses. Participants were randomized 1:1 to receive either one dose of inhaled Recombinant COVID-19 Vaccine (Ad5-nCoV-IH) or intramuscular tozinameran (BNT-IM). The study assessed safety, vaccine efficacy (VE) and immunogenicity against SARS-CoV-2 variants. The primary outcome was the non-inferiority of anti-spike protein receptor-binding domain (S-RBD IgG) antibodies, with a 97.5% confidence interval lower limit for the geometric mean concentration (GMC) ratio >0.67. Ad5-nCoV-IH showed lower immunogenicity than BNT-IM, with a GMC ratio of 0.22 and a seroconversion rate difference of -71.91%. Adverse drug reactions (ADRs) were less frequent with Ad5-nCoV-IH (39.26%) compared to BNT-IM (64.68%). No serious vaccine-related adverse events were reported. Both vaccines had comparable efficacy against COVID-19 variants. This study was funded by Tianjin Biomedical Science and Technology Major Project.

Identifiers

PMID39482336
PMCPMC11527888

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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.