Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Noninferiority Study of Purified Vero Rabies Vaccine-Serum Free in 3-dose and 2-dose Preexposure Prophylaxis Regimens in Comparison With Licensed Rabies Vaccines.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04127786 (Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine - Serum Free Administered at 1 Year Post-3-dose Primary Series, and Between 2 up to 3 Years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand), which is not on this map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine - Serum Free Administered at 1 Year Post-3-dose Primary Series, and Between 2 up to 3 Years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand
Who cites it
2 citing papers in PubMed.
- Imprecision in tuberculosis infection outcomes: implications for non-inferiority vaccine trials.International journal of epidemiology · 2026Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundA next-generation, serum-free, highly purified Vero cell rabies vaccine, PVRV-NG2, is in development.
methodsThis multicenter, observer-blind, phase 3 study evaluated the immunogenicity and safety of PVRV-NG2, compared with 2 licensed rabies vaccines (purified Vero cell rabies vaccine [PVRV] and human diploid cell vaccine [HDCV]), as a preexposure prophylaxis (PrEP) regimen. Participants were randomized 3:1:1 to PVRV-NG2, PVRV, or HDCV, as a 3-dose (cohort 1; children and adults; day [D] 0, D7, and D28) or 2-dose (cohort 2; adults; D0 and D7) PrEP regimen. The primary objective was noninferiority of PVRV-NG2 to PVRV and HDCV as 3-dose PrEP, based on the proportion of participants with rabies virus-neutralizing antibody titer ≥0.5 IU/mL at D42. Noninferiority of immune responses for 2-dose PrEP at D28 and noninferiority of 2-dose (D28) versus 3-dose (D42) HDCV were also assessed as secondary immunogenicity objectives. Safety was assessed throughout.
resultsOverall, 1708 participants were enrolled (cohort 1: 505 children, 505 adults; cohort 2: 698 adults). All participants had rabies virus-neutralizing antibody titers ≥0.5 IU/mL after 3-dose PVRV-NG2 (D42), with noninferiority to PVRV and HDCV demonstrated. All secondary immunogenicity objectives were achieved, including noninferiority of 2-dose PVRV-NG2 versus 2-dose PVRV and HDCV (D28) and 3-dose HDCV (D42), and noninferiority of 2-dose HDCV versus 3-dose HDCV. The safety profile of PVRV-NG2 was comparable to those of PVRV and HDCV.
conclusionsThis study supports the use of PVRV-NG2 in 2- or 3-dose PrEP regimens, with no safety concerns identified. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT04127786; EudraCT: 2019-000973-22; WHO: U1111-1217-3241.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.