Coronavirus vaccine trial : Moderna doses first subject with mRNA-1273 in phase 1 trial
Coronavirus vaccine trial : US biotech company Moderna has dosed the first participant in the phase 1 study of mRNA-1273, its mRNA vaccine against the novel coronavirus (SARS-CoV-2).
The phase 1 coronavirus clinical trial is being carried out under its own Investigational New Drug (IND) application by the National Institutes of Health (NIH).
mRNA-1273 is a vaccine designed to act against the encoding of SARS-CoV-2 for a prefusion stabilized form of the Spike (S) protein, which was chosen by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), which is a part of NIH.
According to the US biotech company, the first clinical batch of the investigational coronavirus vaccine was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
The phase 1 clinical trial is assessing the safety and immunogenicity of three dose levels of mRNA-1273 at 25, 100, and 250 μg injected on a two-dose vaccination schedule, given 28 days apart.
The coronavirus clinical trial will feature 45 healthy adults, who will be followed through 12 months after the second vaccination. The main goal of the coronavirus vaccine trial is to study the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273.
The secondary objective is to assess the immunogenicity to the SARS-CoV-2 S protein, said Moderna.
Tal Zaks – Chief Medical Officer at Moderna, commenting on the coronavirus vaccine trial, said: “This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase 2 study under our own IND.
“We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak.”
In January, Chinese authorities shared the genetic sequence of the novel coronavirus and subsequently, the Vaccine Research Center and Moderna’s infectious disease research team finalized the sequence for the investigational coronavirus vaccine, which was mobilized towards clinical manufacture.
The first clinical batch of the investigational COVID-19 vaccine was completed in early February and had gone through analytical testing.
Moderna said that it is preparing actively for a possible phase 2 coronavirus vaccine trial under its own IND to consolidate on data from the ongoing phase 1 clinical trial.
To continue to progress the potential COVID-19 vaccine during the ongoing global public health emergency, Moderna plans to work with the FDA and other government and non-government organizations to advance to a phase 2 clinical trial and any subsequent studies, which are expected to include a larger number of participants and which will look to provide additional safety and immunogenicity data.