Randomized Controlled Trial of the Immunogenicity and Safety of a Serum-Free Purified Vero Rabies Vaccine (PVRV-NG2) Using a Simulated Postexposure Zagreb Regimen With Human Rabies Immunoglobulin in Adults in Thailand
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Issued Date
2024-11-01
Resource Type
eISSN
23288957
Scopus ID
2-s2.0-85209992901
Journal Title
Open Forum Infectious Diseases
Volume
11
Issue
11
Rights Holder(s)
SCOPUS
Bibliographic Citation
Open Forum Infectious Diseases Vol.11 No.11 (2024)
Suggested Citation
Chansinghakul D., Tantawichien T., Limkittikul K., Ratanasuwan W., Wang Y., Petit C., Guinet-Morlot F., Frago C., Pineda-Peña A.C. Randomized Controlled Trial of the Immunogenicity and Safety of a Serum-Free Purified Vero Rabies Vaccine (PVRV-NG2) Using a Simulated Postexposure Zagreb Regimen With Human Rabies Immunoglobulin in Adults in Thailand. Open Forum Infectious Diseases Vol.11 No.11 (2024). doi:10.1093/ofid/ofae633 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/102225
Title
Randomized Controlled Trial of the Immunogenicity and Safety of a Serum-Free Purified Vero Rabies Vaccine (PVRV-NG2) Using a Simulated Postexposure Zagreb Regimen With Human Rabies Immunoglobulin in Adults in Thailand
Corresponding Author(s)
Other Contributor(s)
Abstract
Background: A serum-free, highly purified Vero rabies vaccine-next generation (PVRV-NG2) is under development. We conducted a phase III trial to describe the safety and immunogenicity profile of PVRV-NG2 compared with those of licensed purified Vero rabies vaccine (PVRV) in a simulated rabies postexposure prophylaxis (PEP) Zagreb regimen in Thailand. Methods: Healthy adults aged ≥18 years (n = 201) were randomized in a 2:1 ratio to receive PVRV-NG2 or PVRV in a rabies PEP Zagreb (days 0, 7, 21 [2-1-1]) regimen, with concomitant human rabies immunoglobulin (HRIG) at day 0. Immunogenicity end points included the proportion of participants with rabies virus-neutralizing antibody (RVNA) titers ≥0.5â€...IU/mL at days 0, 14, and 35. Safety outcomes were also assessed. Results: A total of 199 participants completed the study (PVRV-NG2 n = 133, PVRV n = 66). In the PVRV-NG2 group and PVRV group, respectively, 91.0% (95% CI, 84.1%-95.6%) and 94.6% (95% CI, 85.1%-98.9%) had RVNA titers ≥0.5â€...IU/mL at day 14, increasing to 100% (95% CI, 96.8%-100%) and 100% (95% CI, 93.5%-100%) by day 35. The vaccines had similar safety profiles, and there were no safety concerns. Conclusions: PVRV-NG2 showed acceptable safety and immunogenicity profiles when co-administered with HRIG in a simulated PEP Zagreb regimen in healthy adults in Thailand.