Evidence map›Paper›PMID 25692350›Full record

Trial reportHuman vaccines & immunotherapeutics2015

Immunogenicity and safety of purified chick-embryo cell rabies vaccine under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese children 6 to 17 years old and adults over 50 years: a randomized open-label study.

RongCheng Li, YanPing Li, ShuQing Wen, HuiChun Wen, Yi Nong, Zhaojun Mo, Fang Xie, Michele Pellegrini

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01680016 (A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Post-exposure Schedules), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
0.8field-weighted citation impact, top 29% 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.

NCT01680016 phase3completednot on this map

A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Post-exposure Schedules (Zagreb 2-1-1 and Rabipur® Essen 1-1-1-1-1) in Chinese Children and Older Adults

TypeinterventionalSponsorNovartis VaccinesRan2012 to 2013Enrolled644ConditionsRabiesArmsZagreb, Essen
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Older adults and non-response to rabies post-exposure prophylaxis: Challenges and approaches.Canada communicable disease report = Releve des maladies transmissibles au Canada · 2023
    Article
  14. Neurological sequelae of vaccines.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
    Review
  15. Review
  16. Article
  17. Neglected challenges in the control of animal rabies in China.One health (Amsterdam, Netherlands) · 2021
    Review
  18. 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

8 authors at 4 institutions in 4 countries.

RongCheng Lia Guangxi Center for Disease Prevention and Control ; Guangxi , China.
YanPing Li
ShuQing Wen
HuiChun Wen
Yi Nong
Zhaojun Mo
Fang Xie
Michele Pellegrini
Chinese Center For Disease Control and Prevention · CNGuangxi Center for Disease Prevention and Control · CNNova Medical (United States) · USNovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this Phase IIIb, open-label, randomized study was to demonstrate the non-inferiority of immune responses and to assess the safety of a purified chick-embryo cell rabies vaccine (PCECV) in healthy Chinese children (6 to 17 years) and older adults (≥51 years) following 2 alternative intramuscular (IM) simulated post-exposure prophylaxis (PEP) regimens: 4-dose Zagreb or 5-dose Essen regimen. Serum samples were collected prior to vaccination on Days 1 and 15 and on day 43 to assess immune response by rabies virus neutralizing antibody (RVNA) concentrations. Solicited adverse events (AEs) were recorded for up to 7 days following each vaccine dose, and unsolicited AEs throughout the entire study period. PCECV vaccination induced a strong immune response at Day 15, and the non-inferiority in immune response of the Zagreb vs. the Essen regimen was demonstrated in children and older adults. At Day 15,100% of children (N = 224), and 99% of subjects ≥51 years of age (N = 376) developed adequate RVNA concentrations (≥0.5 IU/mL); at Day 43 all subjects achieved RVNA concentrations ≥0.5 IU/mL, for both PEP regimens. The well-known tolerability and safety profile of the PCECV was again observed in this study following either Zagreb or Essen regimens. Rabies PEP vaccination with PCECV following a Zagreb regimen induced immune responses non-inferior to those of the Essen regimen, and had a similar safety and tolerability profile to the Essen regimen in Chinese children, adolescents, and adults over 51 years. ClinicalTrials.gov identifier: NCT01680016.

Indexed as

AdolescentAgedAged, 80 and overAnimalsAntibodies, NeutralizingAntibodies, ViralChick EmbryoChildChinaDrug-Related Side Effects and Adverse ReactionsFemaleHumansInjections, IntramuscularMaleMiddle AgedPost-Exposure ProphylaxisAntibodies, NeutralizingAntibodies, ViralRabies VaccinesAE, adverse eventCI, confidence intervalEssen regimenGMC, geometric mean concentrationIM, intramuscularimmunogenicityintramuscular post-exposure prophylaxis; purified chick-embryo cell rabies vaccineNIFDC, National Institutes for Food and Drug ControlPCECV, purified chick-embryo cell rabies vaccinePEP, post-exposure prophylaxisPPS, per-protocol setrabiesrabies virus neutralizing antibodyRFFIT, Rapid Fluorescent Focus Inhibition TestRVNA, rabies virus neutralizing antibodyZagreb regimen

Identifiers

PMID25692350
PMCPMC4514244
OpenAlexW1994681680

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.