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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.
Vaccine. 2019 04 10; 37(16):2268-2277.V

Abstract

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.

Authors+Show Affiliations

Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines.Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France.Sanofi Pasteur, 14 Espace Henry Vallée, 69007 Lyon, France. Electronic address: Guy.Houillon@sanofi.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30890382

Citation

Quiambao, Beatriz P., et al. "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." Vaccine, vol. 37, no. 16, 2019, pp. 2268-2277.
Quiambao BP, Ambas C, Diego S, et al. 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. Vaccine. 2019;37(16):2268-2277.
Quiambao, B. P., Ambas, C., Diego, S., Bosch Castells, V., Korejwo, J., Petit, C., & Houillon, G. (2019). 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. Vaccine, 37(16), 2268-2277. https://doi.org/10.1016/j.vaccine.2019.02.083
Quiambao BP, et al. 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. Vaccine. 2019 04 10;37(16):2268-2277. PubMed PMID: 30890382.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Quiambao,Beatriz P, AU - Ambas,Cristina, AU - Diego,Sherylle, AU - Bosch Castells,Valérie, AU - Korejwo,Joanna, AU - Petit,Céline, AU - Houillon,Guy, Y1 - 2019/03/16/ PY - 2018/12/15/received PY - 2019/02/19/revised PY - 2019/02/23/accepted PY - 2019/3/21/pubmed PY - 2020/8/15/medline PY - 2019/3/21/entrez KW - Intradermal regimen KW - Philippines KW - Purified Vero cell rabies vaccine KW - Rabies post-exposure prophylaxis KW - Verorab® SP - 2268 EP - 2277 JF - Vaccine JO - Vaccine VL - 37 IS - 16 N2 - 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/30890382/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(19)30335-4 DB - PRIME DP - Unbound Medicine ER -