title: 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.
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.
authors.affiliation: a Guangxi Center for Disease Prevention and Control ; Guangxi , China.
authors.forename: RongCheng
authors.initials: R
authors.lastname: Li
authors.forename: YanPing
authors.initials: Y
authors.lastname: Li
authors.forename: ShuQing
authors.initials: S
authors.lastname: Wen
authors.forename: HuiChun
authors.initials: H
authors.lastname: Wen
authors.forename: Yi
authors.initials: Y
authors.lastname: Nong
authors.forename: Zhaojun
authors.initials: Z
authors.lastname: Mo
authors.forename: Fang
authors.initials: F
authors.lastname: Xie
authors.forename: Michele
authors.initials: M
authors.lastname: Pellegrini
mesh_terms: D000293:Adolescent; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood*; D000914:Antibodies, Viral / Q000097:blood*; D002642:Chick Embryo; D002648:Child; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D056990:Post-Exposure Prophylaxis / Q000379:methods*; D011818:Rabies / Q000517:prevention & control*; D011819:Rabies Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology* / Q000302:isolation & purification; D013997:Time Factors; D014611:Vaccination / Q000379:methods*
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D011819:Rabies Vaccines
keywords: AE, adverse event; CI, confidence interval; Essen regimen; GMC, geometric mean concentration; IM, intramuscular; NIFDC, National Institutes for Food and Drug Control; PCECV, purified chick-embryo cell rabies vaccine; PEP, post-exposure prophylaxis; PPS, per-protocol set; RFFIT, Rapid Fluorescent Focus Inhibition Test; RVNA, rabies virus neutralizing antibody; Zagreb regimen; immunogenicity; intramuscular post-exposure prophylaxis; purified chick-embryo cell rabies vaccine; rabies; rabies virus neutralizing antibody