Evidence map›Paper›PMID 25483635›Full record

Trial reportHuman vaccines & immunotherapeutics2014

A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults.

Jingchen Ma, Hongchang Wang, Jun Li, Likuan Chang, Yun Xie, Zhonglin Liu, Yuliang Zhao, Claudius Malerczyk, Malerczyk Claudius

Erratum issuedOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
0.5field-weighted citation impact, top 39% 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

14 citing papers in PubMed, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

  • Erratum issued
    Corrigendum.2015 · Claudius, Malerczyk [corrected to Malerczyk, Claudius]
5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Jingchen Maa Hebei Province Center for Disease Prevention and Control ; Heibei , P.R. China.
Hongchang Wang
Jun Li
Likuan Chang
Yun Xie
Zhonglin Liu
Yuliang Zhao
Claudius Malerczyk
Malerczyk Claudius
Hebei Provincial Center for Disease Control and Prevention · CNHengshui University · CNNovartis (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Zagreb regimen has been used for 20 years in various countries. In China, until 2010, the Zagreb schedule was only approved for purified chick embryo cell vaccine (PCECV) and purified Vero cell rabies vaccines (PVRV). In this phase III clinical trial, we aimed to demonstrate the safety and immunogenic non-inferiority of the Zagreb regimen compared with the Essen regimen in healthy adult Chinese immunized with PCECV (Rabipur®). The study enrolled 825 subjects aged 18 to 50 years; serum samples were collected on Days 0, 7, 14, 42, and at 13 months to assess rabies virus neutralizing antibody (RVNA) concentrations. Solicited and unsolicited local and systemic reactions were recorded for 6 days following the day of vaccination, and collected throughout the entire study period (Day 1 until Month 13). The Zagreb regimen was non-inferior to the Essen regimen with regard to RVNA concentrations after 7, 14, and 42 days, and 13 months of immunization. The non-inferiority of seroconversion was established at Days 14 and 42. The incidence of local and systemic reactions was similar between groups, and mostly of mild or moderate severity. Vaccine-related adverse events occurred more frequently in the Essen group than in the Zagreb group. Vaccination with PCECV under a 2-1-1 regimen is as safe and immunogenic as under the traditional 5-dose Essen regimen for rabies post-exposure prophylaxis, and is a more cost-effective option, has a more practical vaccination schedule, and can potentially increase compliance.

Indexed as

Immunization ScheduleVaccinationAdolescentAdultAnimalsAntibodies, NeutralizingAntibodies, ViralChick EmbryoChinaChlorocebus aethiopsCost-Benefit AnalysisFemaleHumansMaleMiddle AgedPost-Exposure ProphylaxisAntibodies, NeutralizingAntibodies, ViralRabies Vaccinesadverse event; CCEEVAEcell culture or embryonated egg-based rabies vaccines; CIchick-embryo cellsconfidence interval; FDAFood and Drug Administration; GMCgeometric mean concentration; HDCVhuman diploid cell rabies vaccine; PCECVimmunogenicityneutralizing antibodyPCECVper protocol set; PrEPpost-exposure prophylaxis; PPSpre-exposure prophylaxis; PVRVpurified chick embryo cell rabies vaccine; PDEVpurified duck embryo cell vaccine; PEPpurified Vero cell rabies vaccine; RFFITrabies vaccinerabies virus neutralizing antibody; SAErapid fluorescent focus inhibition test; RVNAsafetyserious adverse event; WHOWorld Health OrganizationZagreb regimen

Identifiers

PMID25483635
PMCPMC5443097
OpenAlexW2026545771

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.