Receive our newsletter – data, insights and analysis delivered to you
  1. News
March 17, 2020

First US clinical trial of Covid-19 vaccine candidate begins

The first US clinical trial of a Covid-19 vaccine candidate, which is Moderna’s mRNA-1273, has started at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.

Visit our Covid-19 microsite for the latest coronavirus news, analysis and updates


Follow the latest updates of the outbreak on our timeline.

The first US clinical trial of a Covid-19 vaccine candidate, which is Moderna’s mRNA-1273, has started at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.

Funded by the National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID), the trial has dosed its first participant.

mRNA-1273 is an mRNA vaccine designed to target SARS-CoV-2 encoding a prefusion stabilised form of the Spike (S) protein. Moderna selected the candidate in alliance with the Vaccine Research Center (VRC) at the NIAID.

The Coalition for Epidemic Preparedness Innovations (CEPI) funding supported the production of the first clinical batch.

Content from our partners
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide

During the Phase I trial, the safety and immunogenicity of 25μg, 100μg, 250μg dose levels of mRNA-1273 given on a two-dose vaccination schedule 28 days apart will be assessed in a total of 45 healthy adults aged 18 to 55.

The study involves a follow-up of 12 months after the second vaccination.

The primary objective is the safety and reactogenicity of a two-dose vaccination schedule, while the secondary objective is immunogenicity to the SARS-CoV-2 S protein.

Moderna chief medical officer Tal Zaks 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 II 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.”

The potential Phase II and any subsequent trials will further evaluate the safety and immunogenicity of the vaccine candidate in a larger population. Moderna has already started manufacturing the mRNA-1273 material for the Phase II study.

Related Companies

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU