U.S. biotech company Novavax, Inc., has started its phase 2b/3 Hummingbird global clinical trial.
The trial will evaluate the safety, effectiveness (immunogenicity), and efficacy of two doses of the Novavax COVID-19 vaccine (NVX-CoV2373) in younger children aged six months through 11 years, followed by a booster at six months after the primary vaccination series.
“We are excited to begin the Hummingbird trial to study Nuvaxovid’s efficacy in children as young as six months through age 11,” said Stanley C. Erck, president and CEO of Novavax.
“With a successful trial, we may have the opportunity to offer our COVID-19 vaccine to all age groups aged six months and older for protection against this ongoing pandemic.”
The trial will assess the Novavax COVID-19 vaccine in infants (six through 23 months of age), toddlers (two through five years) and children (six through 11 years).
The trial is an age de-escalation trial and age groups will be tested sequentially. Participants have begun dosing in the six to 11-year-old age group. The trial will also have sentinel cohorts in each age group and cohort progression and age-de-escalation will occur after safety review.
The trial will seek to enroll 3,600 participants in the U.S., Mexico, Colombia, Argentina, Spain, U.K., South Africa, Philippines, and Brazil. Initial results are expected in Q1 2023.
About the Novavax COVID-19 vaccine (NVX-CoV2373)
The Novavax COVID-19 vaccine (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
The vaccine was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax has established partnerships for the manufacture, commercialization and distribution of its COVID-19 vaccine worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume.
About Matrix-M adjuvant
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.