Clinical Trials

Date: 2017-07-26

Type of information: Publication of results in a medical journal

phase: 1

Announcement: publication of results in The Lancet

Company: Curevac (Germany)

Product: nadorameran - CV7201 (prophylactic mRNA-based vaccine encoding rabies virus glycoprotein)

Action mechanism: vaccine/mRNA. CV7201 is a mRNA-based rabies vaccine that encodes for the G protein of the rabies virus.

Disease: rabies

Therapeutic area: Infectious diseases

Country: Germany

Trial details:

The purpose of the trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults. This phase I proof-of-concept, open-label, uncontrolled, prospective clinical trial was initiated in a single site – the Department of Infectious Diseases and Tropical Medicine, Medical Centre of the University Hospital of Munich, Germany. From October 2013, the study enrolled 101 healthy adults, with subjects receiving three CV7201 doses either intradermally or intramuscularly by needle-syringe or one of three needle-free devices. Escalating doses were given to subsequent cohorts, and one cohort received a booster dose after one year. Primary endpoints were safety and tolerability, secondary endpoint was the induction of WHO-recommended level of virus neutralizing antibody titers. (NCT02241135)

Latest news:

• On July 26, 2017, CureVac announced that the results of the phase I clinical trial of its RNActive® prophylactic rabies vaccine,CV7201, was published in The Lancet (“Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open label, non-randomized, prospective, first-in-human phase I clinical trial” by Alberer et al). The study was the first in-human proof-of-concept clinical trial of a prophylactic mRNA-based vaccine. Subsequently, the mRNA drug substance encoding a rabies virus glycoprotein was given the International Nonproprietary Name (INN) nadorameran by the World Health Organization (WHO) as first drug substance of this new class. The paper reported results of a phase I clinical trial, which was designed to examine the safety and immunogenicity of this first-generation RNActive® prophylactic vaccine against rabies, Data from the study indicated that CV7201 was generally safe with a reasonable tolerability profile. Importantly the study demonstrated for the first time ever that a prophylactic mRNA-based vaccine candidate can induce boostable functional antibodies against a viral antigen when administered using a needle-free jet injection device. Curevac is now looking forward to continuing a clinical program of its enhanced rabies vaccine in early 2018.