Evidence map›Paper›PMID 33631078›Full record

Trial reportHuman vaccines & immunotherapeutics2021

Safety, immunogenicity of lyophilized purified vero cell cultured rabies vaccine administered in Zagreb and Essen regimen in post-exposure subjects: A post-marketing, parallel control clinical trial.

Lei Zhang, Shichun Huang, Li Cai, Zhenggang Zhu, Jian Chen, Sha Lu, Zerong Zhu, Man Zhang, Yuan Fang, Quan Hu

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

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

12 citing papers in PubMed.

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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

10 authors.

Lei ZhangDepartment of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Shichun HuangDepartment of Academic Research, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.ORCID 0000-0001-6733-0360
Li CaiInstitute of Infectious Disease, Wuhan Center for Disease Control and Prevention, Wuhan, China.
Zhenggang ZhuDepartment of Immunization, Wuhan Center for Disease Control and Prevention, Wuhan, China.
Jian ChenInstitute of Infectious Disease, Wuhan Center for Disease Control and Prevention, Wuhan, China.
Sha LuDepartment of Immunization, Wuhan Center for Disease Control and Prevention, Wuhan, China.
Zerong ZhuPathogen Biology Laboratory, Wuhan Center for Disease Control and Prevention, Wuhan, China.
Man ZhangDepartment of Immunization, Wuhan Center for Disease Control and Prevention, Wuhan, China.
Yuan FangDepartment of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Quan HuDepartment of Public Health, Wuhan Institute of Dermatology and Venereology, Wuhan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To compare the safety and immunogenicity of lyophilized PVRV under Zagreb and Essen regimen.A post-marketing parallel control clinical trial was conducted. Totally 240 subjects were assigned to two groups randomly, immunized with lyophilized PVRV under Zagreb and Essen schedule. Solicited adverse events were observed after each dose and unsolicited adverse events were collected. Serum samples were collected on days 0, 7, 14, 42, 180 and 365 to be used to determine immunogenicity level. No severe adverse events (SAE) were observed. The incidence of adverse events under Zagreb and Essen were similar and there was no significant difference between the two groups and within all age groups. Fever and pain were the most frequently reported systemic and local adverse events (AEs) respectively. There were no differences in the GMT and the positive seroconversion rate between these two groups. All participants in the Zagreb group obtained protective effect on day 14, while 99.16% of the subjects obtained in the Essen group. Both groups showed similar enduring immunity. Immunizations under Zagreb and Essen regimens showed similar safety and immunogenicity. For lyophilized PVRV, Zagreb was non-inferior to Essen to patients of all age groups.

Indexed as

RabiesRabies VaccinesAnimalsAntibodies, ViralChlorocebus aethiopsHumansImmunogenicity, VaccineMarketingVero CellsAntibodies, ViralRabies Vaccinescost-effectivenessHuman rabies vaccineimmunogenicitylyophilizedregimensafety

Identifiers

PMID33631078
PMCPMC8475608

What OpenQuestion holds

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Registered trials

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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.