UC Davis Health in the US and Pfizer are set to collaborate for analysing a Covid-19 booster vaccine in two clinical trials in healthy adult subjects.
Currently, UC Davis is enrolling subjects who have received two doses of the Pfizer Covid-19 vaccine at the Sacramento clinic.
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A second vaccine should be taken a minimum of five months before taking part in the trials.
The trials will evaluate the efficacy of various dose levels of a booster shot and the heart muscle protein levels following administration of a booster.
The first trial will analyse whether varying doses of booster vaccine elicit similar immune responses.
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Subjects will be randomised to receive either the standard 30μg or a 10μg dose of the vaccine during the initial visit and have a total of five clinic visits in a year.
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By GlobalDataThe levels of heart muscle protein, troponin I, before and after inoculation with the booster vaccine will be assessed in the second trial.
UC Davis noted that increased troponin levels are associated with heart injury.
Subjects in this trial will receive both a booster vaccine and a placebo injection at a gap of four weeks.
They will be randomised to receive either of these during the initial visit and have a total of five visits in over two months.
Professional patient care and research services for both trials will be offered by the CTSC Clinical Research Center (CCRC) at the Cypress Building.
UC Davis Department of Internal Medicine professor and chair Timothy Albertson said: “The development and approval of an effective Covid-19 vaccine was an important milestone in our fight against Covid-19.
“But there is still a lot to understand about the virus and the immune response the vaccine creates. This includes studying the continued efficacy and possible side effects of the Covid-19 vaccine.”
In January, Pfizer and BioNTech started a trial of an Omicron-based Covid-19 vaccine candidate in healthy adults aged between 18 and 55 years.
