an earlier setback in their collaboration on an adjuvanted recombinant
protein-based COVID-19 vaccine program last December, France’s Sanofi
(Euronext: SAN) and the UK’s GlaxoSmithKline (LSE: GSK) are moving forward
Sanofi and GSK
today announced today the initiation of a new Phase II study with 720
volunteers aged 18 and over to select the most appropriate antigen dosage for
Phase III evaluation of their adjuvanted recombinant protein COVID-19 vaccine
“Over the past
few weeks, our teams have worked to refine the antigen formulation of our
recombinant-protein vaccine, based on learnings from our initial Phase I/II
study,” said Thomas Triomphe, executive vice president and head of Sanofi
Pasteur. “We are confident that our vaccine candidate has strong potential and
we are very encouraged by the latest pre-clinical data. This new Phase II study
will enable us to identify the final vaccine formulation for adults of all
ages. We have demonstrated our commitment to focusing efforts and capabilities
towards the global fight against the pandemic, and this new study takes us a
step closer to achieving our primary goal of developing a COVID-19 vaccine with
a good efficacy and safety profile,” he added.
president of GSK Vaccines, added: “We are pleased to be starting this new Phase
II study. The world needs multiple vaccines and we are confident that combining
our proven pandemic adjuvant system with this improved antigen formulation will
have significant potential as the pandemic evolves. We look forward to further
progressing this vaccine candidate to Phase III in Q2 2021, if this Phase II
study is successful.”
parallel to the new Phase II study and recognizing the global emergence of new
SARS-CoV-2 variants and their potential impact on vaccine efficacy, Sanofi has
commenced development work against new variants, which will be used to inform
next stages of the Sanofi/GSK development program.
The new Phase
II trial is a randomized, double-blind, multicenter dose finding study
conducted in adults aged 18 years of age and older to evaluate the safety,
reactogenicity, and immunogenicity of two injections given 21 days apart. The
trial will include equal numbers of adults 18 to 59 years and those 60 years
different antigen doses with a fixed dose of adjuvant will be tested in a total
study population of 720 volunteers, in the USA, Honduras and Panama. Results of
the Phase II trial will inform the Phase III protocol.
2020, the Sanofi/GSK
vaccine program was delayed after trial participants were mistakenly given a less concentrated dose, resulting in data that showed a weaker immune response in older people.
partnership between the two companies, Sanofi provides its recombinant antigen
and GSK contributes its pandemic adjuvant, both established vaccine platforms
that have proven successful against influenza. The recombinant technology
combined with GSK’s adjuvant offers the advantages of stability at temperatures
used for routine vaccines, the ability to generate high and sustained immune
responses, and the potential to prevent virus transmission.
Sanofi is also
developing a messenger RNA COVID-19 vaccine in partnership with
Translate Bio (Nasdaq: TBIO). Encouraging pre-clinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi and Translate Bio are planning to start a Phase I/II study in first-quarter 2021.