Gritstone Oncology has announced the dosing of the first subject in a Phase I study of its second-generation candidate Covid-19 vaccine, CORAL.
The multi-centre, open-label, dose- and age-escalation study will assess the immunogenicity and safety of Gritstone’s CORAL Covid-19 vaccine in healthy adult subjects.
The study has a parallel design to analyse both heterologous and homologous prime-boost vaccinations of the adenoviral vector and/or self-amplifying mRNA (SAM) vector expressing either SARS-CoV-2 Spike alone or Spike plus additional SARS-CoV-2 T cell epitopes.
Supported by the US National Institute of Allergy and Infectious Diseases (NIAID), the trial is being carried out through its Infectious Diseases Clinical Research Consortium (IDCRC).
Participants will be enrolled at one of at least three IDCRC sites into various groups depending on their age (18 to 60 and above 60).
Gritstone Oncology co-founder, president and CEO Andrew Allen said: “As we look to the future, we believe CORAL has the potential to address coronavirus immunity challenges that are likely to emerge, particularly around novel Spike variants of concern.
“Building on this NIAID/IDCRC first-in-human study, we are planning to examine the expected broad immunity elicited by our vaccine by delivering it as a boost for people who have received first-generation vaccines in a Phase II study starting later this year.
“We hope that strong CD8+ T cell immunity generated against key non-Spike gene fragments will provide protection against future Spike variants.”
The safety and tolerability of different doses of ChAd-S (or ChAd-S-TCE) and SAM-S (or SAM-S-TCE), when administered as prime and/or boost in healthy participants, will form the study’s primary objective.
Gritstone Oncology Covid-19 vaccine study lead principal investigator Daniel Hoft said: “We are also exploring the potential to use a lower dose of the self-amplifying mRNA vaccine, which could enable more patients to be treated with a given amount of manufactured vaccine.”