CureVac Announces Publication in The Lancet of First-Ever Human Proof-of-Concept Study Investigating the Safety and Immunogenicity of a Prophylactic mRNA Vaccine
- Category: Vaccines
- Published on Thursday, 27 July 2017 09:24
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Data from phase I clinical trial of CureVac’s RNActive® prophylactic vaccine technology in rabies demonstrates for the first time an induction of boostable functional antibodies against a viral antigen when administered via needle-free injection
TÜBINGEN, Germany I July 26, 2017 I CureVac AG, a fully-integrated biotechnology company pioneering mRNA-based drugs, today announced that the results of CureVac’s phase I clinical trial of its RNActive® prophylactic rabies vaccine was published in the peer-reviewed journal The Lancet. 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, titled “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., reported results of the phase I clinical trial, which was designed to examine the safety and immunogenicity of CureVac’s first-generation RNActive® prophylactic vaccine against rabies, CV7201. 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.
Ingmar Hoerr, Ph.D., co-founder and CEO of CureVac, stated, “We are very pleased to have our pioneering phase I study in rabies published in the renowned journal The Lancet. The data demonstrate the potential of our first generation RNActive® prophylactic vaccine technology to induce immune responses in naïve human subjects. The findings from this study have been instrumental in significantly improving our mRNA technology leading to second generation prophylactic vaccines. We now look forward to continuing a clinical program of our enhanced rabies vaccine in early 2018.”
Ulrike Gnad-Vogt, M.D., CMO of CureVac, stated, “While this phase I trial was conducted several years ago and we elected to follow up efficacy and safety for a longer time period, the study is a landmark achievement for CureVac and the mRNA industry as it provided further foundation for understanding mRNA-based vaccines in humans as well as the building blocks for CureVac to develop its next-generation RNActive® technology. On behalf of CureVac, I would like to express my gratitude to the volunteers for participating in the trial, the investigators for their hard work and dedication, and to The Lancet for providing an opportunity to publish this groundbreaking research.”
Andrew Farnum, Director of Program-Related Investments at the Bill & Melinda Gates Foundation, stated “mRNA-based prophylactic vaccines offer the opportunity to address a wide range of infectious diseases, including those that disproportionately affect people in the world’s poorest countries. Although there is a need for further research, these results are an important first step towards realizing the potential of CureVac’s mRNA vaccine technology. We look forward to continuing our collaboration with CureVac that could potentially provide vulnerable communities with the affordable, life-saving vaccines they need.”
The 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.
About The Lancet
The Lancet began as an independent, international weekly general medical journal founded in 1823 by Thomas Wakley. Since its first issue (October 5, 1823), the journal has strived to make science widely available so that medicine can serve, and transform society, and positively impact the lives of people. Over the past two centuries, The Lancet has sought to address urgent topics in our society, initiate debate, put science into context, and influence decision makers around the world.