Perhaps in the not-too-distant future, the COVID-19 vaccine will be administered along with the annual influenza shot. That’s in the works in Australia as the University of Sunshine Coast (USC) soon commences a clinical trial in South East Queensland to evaluate the safety and effectiveness of an investigational combined COVID-19 and influenza vaccine. USC clinics in Brisbane, Moreton Bay, and Sunshine Coast will serve as study trial site locations involving the combination of the Novavax COVID-19 vaccine combined with an influenza vaccine candidate called NanoFlu, for this “two-in-one” vaccination experiment. How will the immune responses be of study subjects first receiving each candidate by itself then combined? Led by Principal Investigator Dr. Nischal Sahai at South Bank in Brisbane, USC seeks healthy volunteers in the age range of 50 to 70 for the study, which starts in several weeks. The study represents the very first time in the nation of Australia that a COVID-19 vaccine is combined with an influenza vaccine for a “single jab “approach, reports Lucas Litewka, Clinical Trials Director for USC.

USC has some familiarity with the American clinical sponsor Novavax, given the track record of working on two previous COVID-19 Novavax studies.

NanoFlu

Developed by Novavax, this investigational product is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine developed in an Sf9 insect cell-baculovirus system. The candidate is developed using HA protein amino acid sequences similar to recommended wild-type HA sequences. Novavax employs its patented saponin-based Matrix-M adjuvant, which exhibits promise as the candidate has been well-tolerated and stimulates quality and sustained antibody responses in addition to CD4 and CD8T-cell responses.

Background

By June 14, Novavax issued a press release announcing data from the first co-administration study of a COVID-19 vaccine candidate (NVX-COV2373) and an approved influenza vaccine [Seqirus, adjuvanted, trivalent seasonal influenza vaccine (aTIV) or a cell-based, quadrivalent seasonal influenza vaccine (QIVc)]. The findings suggest simultaneous vaccination may be a viable immunization strategy. The American biotech company reported that protection afforded by the candidate vaccine was comparable to the main vaccine study at 875% and 89.8%, respectively. Data were included in the preprint server medRxiv

Novavax, as part of a Phase 3 clinical of NVX-CoV2373, evaluated its COVID-19 vaccine candidate in the UK with 431 volunteers who also enrolled in a co-administration sub-study led by St. George and the University of London at St. George’s Hospital, London. The study administered the seasonal influenza vaccine with approximately half the participants co-vaccinated with NVX-CoV2373 while the remaining subjects received a placebo.

This study indicated the potential that vaccine efficacy appeared to be preserved in those subjects receiving both vaccines compared to those with the Novavax COVID-19 vaccine alone.

The USC Study

This study’s formal title is “A Phase 1/2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a Quadrivalent Hemagglutinin Nanoparticle Influenza and SARS-CoV-2 rS Nanoparticle Combination Vaccine with Matrix-M™ Adjuvant in Healthy Participants ≥ 50 to ≤ 70 Years of Age” and was recently approved by the Ethics Committee (EC) from the Alfred Hospital.” 

The study team seeks healthy volunteers between 50 and 70 years old who have received either A) both COVID-19 vaccinations or B) have had COVID-19 at least eight weeks before the first vaccination visit. The subjects are required to attend scheduled visits to the clinic amounting to eight times over six months. Additional screening criteria is introduced in a volunteer interview.

The study involves up to 3 vaccinations using an intramuscular injection between two to three months apart. Eligible participants are reimbursed for time and expenses related to the study.

Principal investigator Point of View

Dr. Sahai, the PI, shared about the study, “This combined protein-based influenza and COVID-19 vaccine candidate is expected to have some important advantages over existing vaccines.” The PI continued, “We are initially targeting older adults for this study because this population bears a disproportionate burden of morbidity and mortality for both influenza and COVID-19.” 

In providing a rationale for combining the COVID-19 and flu shot, the PI further elaborated, “We can see the merits of combining vaccines that may require an annual schedule of delivery, and hope people who have already been vaccinated against COVID-19 can see the value in participating.”

The University of Sunshine Coast Clinical Trials

Established in 1994, the University of Sunshine Coast (USC) is a public university based on the Sunshine Coast, Queensland, Australia. Overall the university has consistently high rankings from independent agencies across several areas.

USC runs a clinical trials office with over 40 drug and device studies completed and ongoing across Phases 1 to 4. TrialSite includes a USC clinical trial summary sheet here.

Lead Research/Investigator

Dr. Nischal Sahai

Read Full Article

Comments

0 Comments

Submit a Comment