1 To 2 Shot Rabies Vaccine Candidate Launches Clinical Study
A small, dose-escalation Phase I clinical trial with the novel mRNA-based rabies vaccine, CV7202 has launched in Germany.
“Our goal is to significantly improve today’s commercial 3-to-5 shot regimen rabies vaccines with a 1 or 2 shot solution that has a markedly longer duration,’ said Dan Menichella, Chief Executive Officer of CureVac AG, in a press release.
This is the first-in-human clinical trial of CureVac AG’s naturally optimized mRNA technology delivered using a lipid nanoparticle (LNP), tailored to provide the vaccine with a strong, safe and persistent immune response.
The study aims to enroll 130 healthy participants who are rabies vaccine naïve. Six escalating dose levels, given by intramuscular needle injection, will be tested.
As a comparator cohort, 10 study participants will receive the marketed treatment Rabipur®.
CV7202 is a prophylactic mRNA-based vaccine encoding the rabies virus glycoprotein, RABV-G, formulated with next-generation LNP.
CureVac’s technology stimulates the immune system to mount a response against an antigen of choice, potentially providing potent prophylactic vaccines for the prevention of infectious diseases, such as rabies.
Rabies is a vaccine-preventable viral disease which occurs in more than 150 countries and territories.
Rabies infection is a disease that is caused by a virus and which is transmitted in many countries by rabid animals through bites, scratches or licking of wounds.
In most cases, humans die from it once the rabies disease has broken out.
In the last 100 years, the number of human deaths from rabies in the United States has fallen from 100 or more per year to an average of 2 or 3 per year, says Immuinize.org.
This decline is due to both the improved control and vaccination of domestic animals and to the development of effective post-exposure treatment and vaccines.
Although human deaths from rabies are now rare in the United States, each year interactions with suspect animals result in the need to observe or test hundreds of thousands of animals and to administer rabies postexposure prophylaxis to 30,000 to 60,000 persons.
Two interchangeable, equally safe, rabies vaccines are available in the United States.
Both vaccines contain inactivated rabies virus.
- HDCV vaccine (Imovax, by Sanofi Pasteur) is produced in human diploid cell culture.
- PCECV vaccine (RabAvert, by Novartis) is produced in chick embryo cell culture. Both types are considered equally safe and effective.
The World Health Organization, the World Organisation for Animal Health (OIE), the Food and Agriculture Organization of the United Nations (FAO) and the Global Alliance for Rabies Control (GARC) have established a global “United Against Rabies” collaboration with the goal of achieving "zero human rabies deaths by 2030".