Our H10N8 mRNA Vaccine (mRNA-1440)
Our investigational H10N8 vaccine is being developed to deliver mRNA encoding for the membrane-bound hemagglutinin 10 (H10) protein. The mRNA directs the cells to produce and express H10 on the cell surface, exactly as a native infection would do but without the ability to cause disease or spread. As a result the body’s immune system responds as if the actual virus is present. The immune system produces antibodies that have the potential to neutralize the virus and prevent infections in the event the vaccinated person is exposed to the actual H10N8 virus in the future.
Moderna strategically selected the H10N8 vaccine as one of its first two clinical development programs (the other, an H7N9 vaccine – mRNA-1851) in order to rapidly assess both the safety and efficacy of its mRNA platform in humans.
Because this strain is not circulating in the general population in Germany, where the trial is taking place, Moderna is able to study the efficacy of its vaccine technology in a naïve patient population. Antibodies present in subjects’ blood after treatment with mRNA-1851 are likely attributed to Moderna’s vaccine and not to active immunity as a result of previous exposure to the virus.
Studying mRNA vaccines for Influenza strains allows Moderna to measure vaccine efficacy against a well-understood endpoint, the hemagglutination inhibition assay, or HAI. HAI is used by U.S. FDA and World Health Organization (WHO) to measure how well antibodies bind to and inactivate an Influenza virus. Vaccines demonstrating titers of 1:40 are considered effective in reducing the risk for Influenza infection and are, thus, approved as seasonal flu vaccines.
- Phase 1 dose-escalating, placebo-controlled, immunogenicity and safety trial in healthy adult volunteers
- Completed enrollment, with a total of 201 subjects enrolled. The study remains active, with subjects continuing to be followed
- Moderna plans to publish topline study findings in 2017 and complete findings in 2018 upon completion of the study and full data analysis