The initial Phase I segment will involve a dose-escalation approach. Credit: PeopleImages.com – Yuri A / Shutterstock.

Curevac has commenced the first phase of a combined Phase I/II clinical trial of a pre-pandemic vaccine candidate targeting the H5N1 avian influenza virus.

Developed in collaboration with GSK, the investigational influenza A (H5N1) pre-pandemic vaccine candidate aims to prepare for potential future pandemic threats.

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The monovalent vaccine candidate utilises CureVac’s second-generation mRNA technology to encode an influenza A H5-antigen.

CureVac’s combined Phase I/II clinical trial aims to assess the vaccine’s safety, reactogenicity, and immunogenicity among two age groups: healthy younger adults aged 18 to 64 and healthy older adults aged 65 to 85.

The initial Phase I segment will involve a dose-escalation approach to evaluate up to five different dose levels against a placebo control. The trial is set to take place in the US.

CureVac chief development officer Dr Myriam Mendila said: “The highly pathogenic avian influenza virus is frequently cited as one of the viruses with high pandemic potential, with cases of animal-to-human transmission of the H5N1 strain already documented.

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“Leveraging our clinically validated mRNA-technology platform and second-generation mRNA backbone, we aim to provide an effective countermeasure to the pandemic threat of potential human-to-human transmission.

“This clinical milestone, in collaboration with GSK, expands the application of our mRNA technology into an additional indication in infectious diseases and addresses the need to be prepared for potential future pandemics.”

In July 2020, CureVac and GSK joined forces to develop new products in prophylactic vaccines for infectious diseases using the former’s mRNA technology.

The partners expanded the collaboration to include the development of second-generation vaccine candidates for Covid-19 and modified mRNA vaccine technologies.

Earlier this year, Curevac announced positive interim data from the Phase II study of its Covid-19 mRNA vaccine candidates.