RABIVAX-S (purified vero cell rabies vaccine) / Serum Institute of India - LARVOL DELTA

Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults (clinicaltrials.gov) - P2 | N=1200 | Recruiting | Sponsor: Serum Institute of India Pvt. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria

VAC087: A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 With Matrix-M in Combination With R21/Matrix-M (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: University of Oxford

New P2 trial • Infectious Disease • Malaria

Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults (clinicaltrials.gov) - P2 | N=1200 | Not yet recruiting | Sponsor: Serum Institute of India Pvt. Ltd.

New P2 trial • Infectious Disease • Malaria

Post-exposure prophylaxis regimen of rabies monoclonal antibody and vaccine in category 3 potential exposure patients: a phase 4, open-label, randomised, active-controlled trial. (PubMed, Lancet) - "RmAb was safe and well tolerated and showed protective efficacy against rabies. A PEP regimen containing RmAb plus PVRV was immunogenic with long-term persistence of immune response."

Clinical • Journal • P4 data

Immunogenicity and safety of the accelerated 2-dose intradermal rabies pre exposure prophylaxis regimen in immunocompetent and immunocompromised pediatric populations: a comparative study. (PubMed, Infection) - "The 2-dose ID PrEP regimen is immunogenic and safe in pediatric populations, including immunosuppressed children. It offers a cost-effective alternative in rabies-endemic regions, enhancing compliance and accessibility."

Journal • Pain • Pediatrics

Safety and immunogenicity of an inactivated vero cell-based rabies vaccine (Rabivax-S) in pre-exposure prophylaxis schedule in Vietnam. (PubMed, Clin Exp Vaccine Res) - P4 | "After this study, Rabivax-S is now available in Vietnam and can be used for pre- and post-exposure prophylaxis. ClinicalTrials.gov Identifier: NCT05937113."

Journal • Dermatology • Pain

Safety and efficacy of the blood-stage malaria vaccine RH5.1/Matrix-M in Burkina Faso: interim results of a double-blind, randomised, controlled, phase 2b trial in children. (PubMed, Lancet Infect Dis) - P2b | "RH5.1/Matrix-M appears safe and highly immunogenic in African children and shows promising efficacy against clinical malaria when given in a delayed third-dose regimen. This trial is ongoing to further monitor efficacy over time."

Journal • P2b data • Allergy • Immunology • Infectious Disease • Malaria

Characterization of the immune responses induced by the Plasmodium falciparum Blood-Stage Vaccine Candidate, RH5.1/Matrix M™, in a Phase IIb trial in Burkinabe 5-17month olds (ASTMH 2024) - P1, P2b | "A total of 360 5-17month olds were randomized to receive 3x 10 μg doses of RH5.1 with 50μg MM (2 groups of N=120 children, in a 0-1-2 month or a delayed 0-1-5 month regimen) or 3x doses of the rabies vaccine, Rabivax-S (2 groups of N=60 children, in a 0-1-2 or 0-1-5 month regimen). Type of vaccine delivery system, regimen and demographic characteristics of vaccinees have been shown to have substantial impact on anti-RH5 immune responses in studies to date. Here, we report the effects of monthly vs delayed third dose regimen on humoral response magnitude, quality and durability, as well as functional GIA assessment of antibody responses in the first opportunity for correlation with clinical malaria outcome for RH5-based vaccines."

P2b data • Infectious Disease • Malaria

Development of an ELISA for an effective potency determination of recombinant rabies human monoclonal antibody. (PubMed, J Immunol Methods) - "An In-vitro ELISA test has been developed as an alternative to the RFFIT assay, for quantifying the rabies monoclonal antibody (mAb) potency using inactivated rabies virus vaccine (Rabivax-S)...It is easy to perform, and it has a short turnaround time (results available in few hours). Furthermore, it is cost effective and can be performed with low-cost resource setting, as there is no requirement of handling the live cells and live virus and also BSL-2 Facility."

Journal

Active safety surveillance of rabies monoclonal antibody and rabies vaccine in patients with category III potential rabies exposure. (PubMed, Lancet Reg Health Southeast Asia) - "A vero cell-based inactivated Rabies Vaccine (Rabivax-S) and Rabies Human Monoclonal Antibody (Rabishield) have been approved since 2016. No participant developed rabies during 31 day follow up. The PMS was funded by Serum institute of India Private Limited which is the manufacturer of the study products."

Journal • Musculoskeletal Diseases • Orthopedics

Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally (clinicaltrials.gov) - P4 | N=220 | Completed | Sponsor: Vietnam Military Medical University

New P4 trial