Evidence map›Paper›PMID 40016280›Full record

Trial reportScientific reports2025

A phase 3 clinical trial on the immunogenicity and safety of booster vaccination after Zagreb or Essen regimens.

Hua-Kun Lv, Xu Chen, Bo Xing, Xiao-Song Hu, Xin-Pei Zhang, Yu-Gang Shen, Yan Wang, Miao-Miao Liu, Ying-Ping Chen, Zhen-Zhen Liang and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Hua-Kun Lv *Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China. hklv@cdc.zj.cn.
Xu ChenNational Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, China.
Bo XingZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.
Xiao-Song HuZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.
Xin-Pei ZhangShangyu Center for Disease Control and Prevention, Shaoxing, China.
Yu-Gang ShenShengzhou Center for Disease Control and Prevention, Shaoxing, China.
Yan WangLiaoning Chengda Biological Limited by Share Ltd, Shengyang, China.
Miao-Miao LiuLiaoning Chengda Biological Limited by Share Ltd, Shengyang, China.
Ying-Ping ChenZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.
Zhen-Zhen LiangZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China. zzliang@cdc.zj.cn.
Yu MaoLiaoning Chengda Biological Limited by Share Ltd, Shengyang, China. maoyu0516@Sina.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Zagreb and Essen regimens are comparable in terms of immunogenicity; however, how these regimens impact the immunogenicity of booster vaccination remains unknown. We conducted a clinical trial to assess the immunogenicity of booster vaccination with a purified Vero cell rabies vaccine after primary vaccination with the Zagreb or Essen regimens. This randomized, open-label, controlled, phase 3 trial, conducted in Shangyu City and Shengzhou City, Zhejiang Province, China, was divided into the primary and booster vaccination phases. After screening, all eligible participants were allocated to groups A, B, C, D, E, or F. Groups A, B, and C received the Zagreb regimen as the primary vaccine, while groups D, E, and F received the Essen regimen. The booster vaccination was conducted 6 months after the primary vaccination. Groups B and E received one dose of the booster, while groups C and F received two doses. Blood samples were collected before the booster, at 14 days after the booster, and at approximately 6 months after the booster. Safety was assessed from the first booster dose to 6 months after the final dose. A total of 718 participants completed the booster vaccination. The antibody positive rate (APR) of groups B, C, E, and F after the booster was 100%. The antibody titer rose significantly even after one booster, and was much higher in groups B (48.80 IU/ml) and C (64.38 IU/ml) (receiving Zagreb) than in groups E (34.25 IU/ml) and F (42.89 IU/ml) (receiving Essen). Although the incidence of ARs was higher in groups B (11.22%) and C (15.79%) than in groups E (3.68%) and F (10.87%), they were all mild and short-lived. No serious adverse events (SAEs) associated with vaccination were reported. The immunogenicity of booster vaccination after the Zagreb regimen was significantly higher than that after the Essen regimen. One booster may be sufficient to raise the antibody titer above the 0.5 IU/mL target.Clinical trial registration: This trial is registered at http://www.chinadrugtrials.org.cn/index.html under the registration number CTR20210426 at 08/03/2021.

Indexed as

Immunization, SecondaryImmunogenicity, VaccineRabiesRabies VaccinesAdolescentAdultAnimalsAntibodies, ViralChinaFemaleHumansMaleMiddle AgedRabies virusVaccinationYoung AdultAntibodies, ViralRabies VaccinesBoosterEssen regimenImmunogenicityPurified Vero cell rabies vaccineSafetyZagreb regimen

Identifiers

PMID40016280
PMCPMC11868620

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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.