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Clinical Trials

Date: 2012-11-25

Type of information:

phase: preclinical data

Announcement: publication of in vivo data in Nature Biotechnology (http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt.2436.html)
‘Protective efficacy of in vitro synthesized, specific messenger RNA vaccines against influenza A virus infection'

Company: CureVac (Germany) Friedrich-Loeffler-Institute (FLI - Germany)

Product: mRNA vaccines

Action mechanism:

Disease: influenza A

Therapeutic area: Infectious diseases

Country:

Trial details:

Latest news: CureVac GmbH, a clinical stage biopharmaceutical company developing a new class of therapies and vaccines based on mRNA, and the German Federal Research Institute for Animal Health, Friedrich-Loeffler-Institute (FLI), Germany, announced the publication in Nature Biotechnology of in vivo data showing that mRNA vaccines (RNActive) based on CureVac’s RNA technology platform have the potential to provide effective protection against infectious diseases. These data  show that mRNA vaccines induced balanced, long-lived and protective immunity to influenza A virus infections in various animal models. It is also shown that the production of RNActive vaccines is highly flexible. Thus, RNActive vaccines can be rapidly supplied for a variety of virus strains and subtypes identified in response to pandemic scenarios.
The authors demonstrated that the mRNA vaccine encoding full-length hemagglutinin (HA) of the influenza A/PuertoRico/8/1934 (PR8HA) strain was immunogenic and induced balanced Band T-cell responses in mice. Influenza A viruses are classified based on the expression of a certain subtype of HA and a certain subtype of neuraminidase (NA). HA forms the basis of all licensed influenza vaccines. Furthermore, the immunized mice were protected against death and disease upon infectious challenge by an antibody-dependent mode-of-action. Moreover, the authors targeted additional influenza A virus strains by sequence-matched, HA-specific vaccines, and showed that all vaccines induced full protection against lethal infections, including H1N1pdm09 swine flu and H5N1 bird flu virus. The mRNA vaccine was immunogenic and provided long-term protection in newborn as well as in aged mice.
Additional data revealed that full protection was achieved upon single-dose immunization against influenza A/PR8 with a multi-component HA and NA mRNA vaccine. Furthermore, mRNA vaccines provided heterologous protection; vaccination with PR8 nucleoprotein (NP) mRNA led to protection against homologous PR8 (H1N1) or heterologous MB1 (H5N1) virus. Moreover, mRNA vaccines provided immunogenicity in ferrets, the animal model of choice for preclinical proof-of-concept studies in influenza research, and pigs compared to a licensed trivalent vaccine of corresponding specificity.

Is general: Yes