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- Title
Immunogenicity and Safety of a Purified Vero Rabies Vaccine—Serum Free, Compared With 2 Licensed Vaccines, in a Simulated Rabies Post-Exposure Regimen in Healthy Adults in France: A Randomized, Controlled, Phase 3 Trial.
- Authors
Pineda-Peña, Andrea-Clemencia; Jiang, Qian; Petit, Celine; Korejwo-Peyramond, Joanna; Donazzolo, Yves; Latreille, Mathilde; Homery, Marie-Claude; Babin, Valerie; Benamor, Sonia; Pichon, Sylvie; Guinet-Morlot, Françoise; Minutello, Ada-Maria
- Abstract
Background A next-generation Vero cell rabies vaccine (PVRV-NG2) was developed using the same Pitman–Moore strain as in the licensed purified Vero cell vaccine (PVRV; Verorab) and the human diploid cell vaccine (HDCV; Imovax Rabies®). Methods This dual-center, modified, double-blind, phase 3 study evaluated the immunogenic non-inferiority and safety of PVRV-NG2 with and without concomitant intramuscular human rabies immunoglobulin (HRIG) versus PVRV + HRIG and HDCV + HRIG in a simulated post-exposure prophylaxis (PEP) regimen. Healthy adults ≥18 years old (N = 640) were randomized 3:1:1:1 to PVRV-NG2 + HRIG, PVRV + HRIG, HDCV + HRIG, or PVRV-NG2 alone (administered as single vaccine injections on days [D] 0, D3, D7, D14, and 28, with HRIG on D0 in applicable groups). Rabies virus neutralizing antibodies (RVNA) titers were assessed pre- (D0) and post-vaccination (D14, D28, and D42) using the rapid fluorescent focus inhibition test. Non-inferiority, based on the proportion of participants achieving RVNA titers ≥0.5 IU/mL (primary objective), was demonstrated if the lower limit of the 95% CI of the difference in proportions between PVRV-NG2 + HRIG and PVRV + HRIG/HDCV + HRIG was >−5% at D28. Safety was assessed up to 6 months after the last injection. Results Non-inferiority of PVRV-NG2 + HRIG compared with PVRV + HRIG and HDCV + HRIG was demonstrated. Nearly all participants (99.6%, PVRV-NG2 + HRIG; 100%, PVRV + HRIG; 98.7%, HDCV + HRIG; 100%, PVRV-NG2 alone) achieved RVNA titers ≥0.5 IU/mL at D28. Geometric mean titers were similar between groups with concomitant HRIG administration at all time points. Safety profiles were similar between PVRV-NG2 and comparator vaccines. Conclusions In a simulated PEP setting, PVRV-NG2 + HRIG showed comparable immunogenicity and safety to current standard-of-care vaccines. Clinical Trials Registration NCT03965962.
- Subjects
FRANCE; IMMUNOGLOBULIN analysis; RABIES vaccines; PATIENT safety; RESEARCH funding; BLIND experiment; STATISTICAL sampling; RANDOMIZED controlled trials; SIMULATION methods in education; PRE-tests &; post-tests; VACCINE immunogenicity; RESEARCH; COMPARATIVE studies; CONFIDENCE intervals
- Publication
Clinical Infectious Diseases, 2024, Vol 78, Issue 6, p1748
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciae137