Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines.

Autor: Quiambao BP; Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines., Ambas C; Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines., Diego S; Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines., Bosch Castells V; Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France., Korejwo J; Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France., Petit C; Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France., Houillon G; Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France. Electronic address: Guy.Houillon@sanofi.com.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2019 Apr 10; Vol. 37 (16), pp. 2268-2277. Date of Electronic Publication: 2019 Mar 16.
DOI: 10.1016/j.vaccine.2019.02.083
Abstrakt: Background: Rabies post-exposure prophylaxis (PEP) via intradermal (ID) administration is standard practice in Asia. Accumulating evidence suggests that PEP shortened to 3 visits in one week does not adversely affect seroconversion rates or immune memory.
Objective: To determine whether the seroconversion rate at Day14 with a 1-week, 4-site (4-4-4-0-0) ID vaccination regimen with or without rabies immunoglobulin (RIG) was non-inferior to the updated Thai Red Cross (TRC) 28-day, 2-site (2-2-2-0-2) ID regimen with RIG during rabies PEP. We also assessed one-year antibody persistence.
Methods: This phase III, mono-center, open-label, randomized-controlled trial assigned participants aged ≤50 years (n = 600) exposed to suspected rabid animals and sustaining WHO Category II injuries (automatic allocation to G1) or Category III injuries (randomized to G2 or G3) to the following groups (1:1:1 ratio): G1 (n = 200), 1-week 4-site ID regimen with the purified Vero cell rabies vaccine (PVRV; Verorab®) without RIG; G2 (n = 201), 1-week 4-site ID regimen with PVRV, and purified equine rabies immunoglobulin (pERIG); G3 (n = 199), TRC 28-day, 2-site ID regimen with PVRV, and pERIG. Non-inferiority tests compared G1 vs. G3 and G2 vs. G3. Seroconversion rate was the proportion (%) of vaccinees with rabies virus neutralizing antibodies (RVNA) titers ≥0.5 IU/mL measured by rapid fluorescent focus inhibition test.
Results: On Day14, after the third vaccine administration, seroconversion rates were non-inferior in both comparisons and were, respectively, 100%, 99.4%, 98.8% in G1, G2, G3 with a decrease to 97.6%, 89%, 79.8% at Year 1. At Day14, RVNA geometric mean titers were 11.3 IU/mL; 9.89 IU/mL; 6.15 IU/mL, respectively, decreasing to 2.96 IU/mL, 1.37 IU/mL, 0.97 IU/mL at Year1. Safety and tolerability were similar between the three groups.
Conclusion: The seroconversion rate at Day 14 with the 1-week 4-site ID regimen, both with and without pERIG, was non-inferior to the reference TRC 28-day 2-site ID regimen with pERIG during rabies PEP with PVRV. ClinicalTrials.gov ID: NCT01622062.
(Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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