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CureVac initiates rabies vaccine trial
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CureVac AG announced that the first study participant has been enrolled in its phase 1 dose-escalation clinical trial of an mRNA-based rabies vaccine.
The trial will assess the safety, reactogenicity and potential protective immune response of the vaccine, CV7202, according to a news release. It is the first-in-human trial of CureVac’s naturally optimized mRNA technology delivered using a lipid nanoparticle (LNP), which gives the vaccine a strong, safe and persistent immune response, the company said.
“The development of improved human prophylactic vaccines is considered key to an effective rabies control strategy ultimately leading to elimination in humans,” Frank Bähner, MD, area head of prophylactic vaccines at CureVac AG, told Infectious Disease News.
Rabies virus is primarily transmitted to humans through dogs and is almost always fatal upon the onset of clinical symptoms. The disease, preventable through vaccination, occurs in more than 150 countries worldwide and causes tens of thousands of deaths each year, mostly in Asia and Africa, according to the release.
CV7202 is a prophylactic mRNA-based vaccine that encodes the rabies virus glycoprotein with next generation LNP, according to CureVac. The company said its platform of mRNA-based therapeutics optimizes the properties of mRNA, including stability and immunogenicity achieved using enhanced naturally occurring building blocks.
The vaccine trial, identified on ClinicalTrials.gov as NCT03713086, will enroll 130 healthy people who have never been vaccinated against rabies. Participants will be given intramuscular needle injections of six escalating dose levels. A comparator cohort made up of 10 study participants will receive doses of the marketed treatment for rabies, Rabipur (Novartis).
The goal is to improve the current three-to-five shot solution for rabies and replace it with a one- or two-shot solution with longer durability. The primary objective of the phase 1 trial is to study the safety and reactogenicity of CV7202.
“CureVac’s vaccine candidate has the potential to significantly simplify vaccine manufacturing and product release and therefore improve the availability of vaccine, and enhance the compliance to vaccination by limiting the number of administrations needed, in countries where it is needed the most,” Bähner said. – by Erin Michael
Disclosures: Bähner works for CureVac AG.