Novavax has reported preliminary data from the Phase I/II clinical trial of its COVID-Influenza Combination Vaccine (CIC).
The CIC merges Novavax’s Covid-19 vaccine, NVX-CoV2373, with the company’s quadrivalent influenza vaccine candidate.
A protein-based vaccine, NVX-CoV2373 is created from the genetic sequence of the SARS-CoV-2 virus’ first strain.
The trial is designed to analyse a combination of NVX-CoV2373, influenza vaccine candidates and Matrix-M adjuvant in one formulation.
Being carried out at ten sites in Australia, the trial will assess the safety, tolerability and immune response to the combination vaccine in 642 healthy adults aged 50 to 70 years.
Trial participants should have had Covid-19 infection or inoculated with authorised vaccines at least eight weeks before enrolment.
Various formulations of the vaccine will be analysed and subjects will receive the vaccine on days zero and 56.
According to the initial trial data, the CIC was found to be well-tolerated, immunogenic, and showed that formulating the combination vaccine was feasible.
The combination vaccine’s safety and tolerability profile was in line with the standalone NVX-CoV2373 and influenza vaccine reference formulations.
Rare or no serious adverse events related to the vaccine were reported.
Furthermore, various formulations of the CIC vaccine elicited immune responses in subjects compared to reference standalone influenza and Covid-19 vaccine formulations.
The combined formulation demonstrated the potential to reduce the total antigen amount by up to 50% overall in modelling results, enhancing production and delivery.
These findings support progressing to the Phase II confirmation trial, anticipated to commence by the end of this year.
Novavax Research and Development president Gregory Glenn said: “We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both Covid-19 and seasonal influenza.
“We’re encouraged by these data and the potential path forward for a combination Covid-19-influenza vaccine, as well as standalone vaccines for influenza and Covid-19.”
In March this year, the company reported that its Covid-19 vaccine, NVX-CoV2373, will be analysed as a booster in two trials.