German biotech company CureVac is planning to expand the protocols for its ongoing late-stage trials of its COVID-19 vaccine candidate CVnCoV to determine if the jab is effective against new virus variants.
The CVnCoV vaccine candidate is currently being evaluated in the HERALD phase 2b/3 trial in Europe and Latin America.
Due to the rapid emergence of new virus variants in the countries where the study is being conducted, CureVac has identified the need for further analysis specification for the anticipated case-driven interim analysis.
This will allow CureVac to determine the efficacy of the vaccine candidate against select variants, the company said in a statement.
CureVac is in ongoing discussions with the European Medicines Agency (EMA) to potentially include an amendment to the study related to select virus strains.
In addition, for the company’s phase 2a dose-confirmation trial in older adults in Peru and Panama, CureVac has now submitted a protocol amendment to include a secondary objective for vaccine efficacy.
Initially, the study aimed to evaluate safety, reactogenicity and immunogenicity of CvnCoV in adult participants.
“The additional efficacy analysis in phase 2a is intended to leverage the data we can collect from older adults, and will represent important complementary data to the statistically relevant efficacy data from our HERALD trial,” said Ulrike Gnad-Vogt, interim chief development officer of CureVac.
“At the same time we need to make sure that our efficacy data is meaningful in view of the emergence of new virus variants. We are therefore aiming to specify what type of virus we are dealing with in the HERALD trial,” he added.
Data from both clinical trials is expected in the second quarter of 2021, which reaffirms CureVac’s plan to file for formal marketing authorisation within the second quarter of the year.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) started its rolling review of CVnCoV in February.
In November 2020, CureVac revealed early data for its investigational COVID-19 vaccine showing that the jab triggered an immune response in participants in a phase 1 study.
The mRNA-based vaccine candidate also induced strong binding and neutralising antibody responses in the early study, according to CureVac.