Rabavert (purified chicken-embryo cell rabies vaccine) / Bavarian Nordic - LARVOL DELTA

Washington University WU 409: Immune Responses to Rabies Vaccine. (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Washington University School of Medicine | Initiation date: Jul 2023 ➔ Oct 2023

Trial initiation date

An Open Label, Single Arm, Phase I/II Clinical Study of Autologous CD4+ T-Cells Edited Ex-Vivo at the CD40LG Locus by CRISPR/Cas9 and IDLV-based vector in Patients with X-linked Hyper IgM Syndrome Type 1 (HIGM1) (clinicaltrialsregister.eu) - P1/2 | N=4 | Not yet recruiting | Sponsor: Fondazione Telethon Ets, San Raffaele Hospital

New P1/2 trial • Immunology • Primary Immunodeficiency

BAZOOKA_221: A multicentre, open-label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming. (clinicaltrialsregister.eu) - P2/3 | N=561 | Not yet recruiting | Sponsor: Institute Of Tropical Medicine

New P2/3 trial • Infectious Disease

Factors influencing rabies vaccines immunogenicity during post-exposure prophylaxis: a systematic literature search and meta-analysis. (PubMed, Vaccine) - "Although RVNA GMTs appear to have decreased by titration year, there was no clinically meaningful impact on immunogenicity, and the three licensed rabies vaccines assessed are expected to provide similar protection."

Journal • Retrospective data • Review

A study to compare the efficacy of an intradermal and an intramuscular single-visit dosing regimen of the rabies vaccine in adults (clinicaltrialsregister.eu) - P2/3 | N=360 | Completed | Sponsor: Institute Of Tropical Medicine | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion

Five-year boostability after single-visit single-dose intramuscular rabies pre-exposure prophylaxis (clinicaltrialsregister.eu) - P4 | N=240 | Recruiting | Sponsor: Academisch Ziekenhuis Leiden | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Washington University WU 409: Immune Responses to Rabies Vaccine. (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Washington University School of Medicine

New P1 trial

ARPEP: Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies (clinicaltrials.gov) - P2 | N=448 | Completed | Sponsor: Synermore Biologics Co., Ltd. | Phase classification: P2b ➔ P2

Phase classification

Durability of next-generation self-replicating RNA vaccine RBI-4000: a phase 1, randomized open label clinical trial. (PubMed, Commun Med (Lond)) - P1 | "We report the first durability data from a head-to-head study of an optimized self-replicating RNA vaccine for rabies that elicits sustained immune responses compared to a commercial comparator that uses a traditional vaccine technology."

Journal • P1 data

Association between tick-bite history and safety of gelatin-containing vaccines: Analysis of a large database of the United States. (PubMed, Ticks Tick Borne Dis) - "Vaccines were classified into two categories: (1) gelatin-containing vaccines (live intranasal influenza [FluMist], varicella, measles/mumps/rubella [MMR], oral typhoid, rabies [RabAvert], and yellow fever vaccines [YF-VAX]) and (2) gelatin-free vaccines...While tick bites are associated with AGS, a history of tick bites is not a contraindication for most gelatin-containing vaccines, including MMR, oral typhoid, rabies, and yellow fever vaccines. Further investigations are warranted to evaluate the safety of intranasal influenza and varicella vaccines in this population."

Journal • Allergy • Immunology • Infectious Disease • Influenza • Measles • Mumps • Respiratory Diseases • Rubella • Varicella Zoster

A Trial of a Peptide-based Group A Streptococcal (GAS) Vaccine Candidate in Healthy Individuals. (clinicaltrials.gov) - P1/2 | N=30 | Completed | Sponsor: University of Alberta | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ May 2025

Trial completion • Trial completion date • Infectious Disease

Burden of human rabies disease: its potential prevention by means of Rabipur® vaccine. (PubMed, J Prev Med Hyg) - "In rabies-free countries, PrEP is indicated for individuals who face occupational and/or travel-related exposure to the rabies virus in specific settings or over an extended period. Wider use of human rabies vaccination for PrEP and PEP in conjunction with programs to eradicate rabies from animal populations is the challenging goal in order to reduce the burden of disease and achieve zero rabies."

Journal • Review • Infectious Disease

A Non-Inferiority Trial Comparing Two Vaccines (Rabix-vc vs. Rabipur) for Rabies among Adults in Dhaka, Bangladesh (ASTMH 2024) - "Therefore, this clinical trial was determined to be sufficient to confirm the immunogenicity and safety of Rabix-vc vaccine for Rabies virus infection. These results suggest that locally manufactured Rabix-vc vaccine is non-inferior to the well-known licensed Rabipur vaccine."

Clinical • Head-to-Head • Infectious Disease

Safety and immunogenicity of a ChAd155-vectored rabies vaccine compared with inactivated, purified chick embryo cell rabies vaccine in healthy adults. (PubMed, Vaccine) - "In this phase 1 clinical trial, a novel rabies vaccine using a simian adenovirus vector was safe and tolerable, but generated lower, less durable rabies VNA titers than a standard inactivated rabies virus vaccine, which may be due to preexisting, anti-vector immunity."

Clinical • Journal • CNS Disorders • Hematological Disorders • Neutropenia

A Trial of a Peptide-based Group A Streptococcal (GAS) Vaccine Candidate in Healthy Individuals. (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: University of Alberta | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Oct 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

A Study of RBI-4000 in Healthy Participants (clinicaltrials.gov) - P1 | N=89 | Terminated | Sponsor: Replicate Bioscience | Trial completion date: Apr 2025 ➔ Jul 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2025 ➔ Jul 2024; Strategic business decision (not related to safety, efficacy, or quality)

Trial completion date • Trial primary completion date • Trial termination

A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis. (clinicaltrials.gov) - P3 | N=459 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Infectious Disease

Single and Low Dose Self-Replicating RNA Vaccine Provides Effective Immune Protection Against Rabies in Healthy Volunteers (ASGCT 2024) - P1 | "RBI-4000 was evaluated in a Phase I clinical trial (NCT06048770).Healthy adults, age 18-45 and seronegative for rabies antibodies were recruited at two clinical sites in the U.S. Sequential cohorts (n=18 subjects) were dosed IM with 0.1, 1, or 10 micrograms (mcg) of RBI-4000 in a 2-dose prime-boost schedule or prime only for the highest dose...The favorable safety profile combined with strong immunogenicity demonstrates an orders of magnitude advance in the therapeutic window of efficacy: tolerability over traditional mRNA vaccines. The increased therapeutic window enables broader applications of our platform to more complex infectious disease targets, oncology applications, and protein replacement therapeutics as well as being better able to address acute pandemic manufacturing requirements."

Clinical • Infectious Disease • Influenza • Novel Coronavirus Disease • Oncology • Respiratory Diseases

A Study of RBI-4000 in Healthy Participants (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: Replicate Bioscience | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults (clinicaltrials.gov) - P1 | N=160 | Completed | Sponsor: GlaxoSmithKline | N=82 ➔ 160

Enrollment change • Infectious Disease

Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion

A Trial of a Peptide-based Group A Streptococcal (GAS) Vaccine Candidate in Healthy Individuals. (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: University of Alberta

Trial completion date • Trial primary completion date • Infectious Disease

A Study of RBI-4000 in Healthy Participants (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Replicate Bioscience

New P1 trial

"I had a bat in my bedroom. Didn’t see any bite marks, but feel I should get a boost of Rabipur." (,@hauserbua)

Unmodified rabies mRNA vaccine elicits high cross-neutralizing antibody titers and diverse B cell memory responses. (PubMed, Nat Commun) - "The mRNA vaccine also generates higher RABV-G binding and neutralizing antibody titers than Rabipur, while the degree of somatic hypermutation and clonal diversity of the response are similar for the two vaccines. The higher overall antibody titers induced by the mRNA vaccine translates into improved cross-neutralization of related lyssavirus strains, suggesting that this platform has potential for the development of a broadly protective vaccine against these viruses."

Journal