Dose Escalation Approved and Dosing Commenced in Second Cohort of GPN Vaccines’ Phase 1 Clinical Trial in Older Adults
The Phase 1 clinical trial is assessing the safety, tolerability and immunogenicity of Gamma-PN. One hundred and five healthy volunteers aged 70 and over are being recruited into the trial, of which ninety will be vaccinated with two doses of Gamma-PN at three different dose levels. The remainder of volunteers will be given the licensed pneumococcal vaccine Prevnar13®.
Cohort one, involving administration of 500 μg of Gamma-PN to thirty participants, was recently completed. The Safety Review Committee met subsequently to review the available safety data, and approved progression to cohort two in which a further thirty participants will receive 1000 μg of Gamma-PN vaccine.
Importantly, the committee noted there were no safety issues of concern related to the vaccine. The clinical trial is being conducted at CMAX in Adelaide, one of Australia’s largest and most experienced clinical trials centres.
GPN Vaccines' Chief Medical Officer Professor Paul Rolan, said "We are delighted to be building a comprehensive data package that suggests we have a safe vaccine and thus far supports dose escalation in the second cohort of participants.”
Cohort two is expected to be completed by the end of Q4, with Cohort 3 commencing early in the new year.
About GPN Vaccines
GPN Vaccines is a clinical stage, public (unlisted) biotechnology company focussed on creating innovative vaccines that offer robust protection against the world’s most important bacterial pathogens. Our lead product, Gamma-PN, targets Streptococcus pneumoniae which is responsible for causing life-threatening pneumonia, bacteraemia and meningitis, as well as otitis media (middle ear infections). There are over 100 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 20 of them. Gamma-PN is being developed to protect children and adults against all S. pneumoniae strains, regardless of strain serotype. Additional vaccines are also in development that target other bacterial respiratory infections and are designed to offer similar broader spectrum immunity.
Paul Rolan
GPN Vaccines
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