CureVac is set to launch a new phase 3 study of its COVID-19 vaccine in healthcare workers at the University Medical Center Mainz in Germany.
The Tübingen, Germany-headquartered company expects to vaccinate the first participant in this phase 3 study on 22 December 2020.
The study will evaluate the safety and efficacy of CureVac’s investigational CVnCoV vaccine, which will be administered as a two-dose regimen.
The planned phase 3 study in healthcare workers builds on CureVac’s ongoing non-interventional study, which is investigating the distribution of COVID-19 in employees at University Medical Center Mainz.
The epidemiological study is focused on how and at what rate SARS-CoV-2-specific antibodies arise and can be detected in hospital employees, as well as the frequency of virologically confirmed COVID-19 cases in this cohort.
The University Medical Center Mainz study complements CureVac’s recently initiated global phase 2b/3 trial, which is evaluating CVnCoV in over 35,000 participants.
“With this clinical study in healthcare workers, we aim to investigate the difference our vaccine candidate can make in this specific group of individuals who are at particularly high risk of potential infection due to viral exposure,” said Lidia Oostvogels, head of infectious diseases of CureVac.
“Based on this trial, we hope to gain additional insights for effective prevention of COVID-19 in this vulnerable population,” she added.
In CureVac’s phase 1 study of CVnCoV, the investigational mRNA-based vaccine induced strong binding and neutralising antibody responses, as well as early indications of functional T cells.
mRNA technology has been in the spotlight during the race to develop a COVID-19 vaccine, with a number of companies utilising this research area to develop innovative vaccines for the novel coronavirus.
The companies include Pfizer/BioNTech, Moderna and CureVac Both Pfizer/BioNTech and Moderna have received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for their respective mRNA-based vaccines.
In November, CureVac announced that CVnCoV has up to 24 hours of stability when stored at room temperature.
CureVac also said that data for its potential COVID-19 vaccine, CVnCoV, suggests the vaccine remains stable and within defined specifications for at least three months when stored at a standard refrigerator temperature of +2°C to +5°C (+41°F).
In comparison, Pfizer/BioNTech’s vaccine needs to be stored at -70 °C, with Moderna’s vaccine remaining stable at standard refrigerator temperatures for 30 days and up to six months at -20° C.