June 2021 • PharmaTimes Magazine • 12
// COVID-19 //
A clinical trial has launched in the UK to test the safety and effectiveness of administering a third dose of seven different COVID-19 vaccines.
The Cov-Boost study, led by University Hospital Southampton NHS Foundation Trust and backed by £19.3 million of government funding through the Vaccines Taskforce, will be the first in the world to provide data on the impact of a third dose on patients’ immune responses.
The study will take place at 16 NIHR (National Institute for Health Research) supported sites across England, and also within Health and Care Research Wales and NHS Research Scotland sites.
A total of 2,886 patients and participants are to begin receiving one of seven vaccinations as part of the study from early June, at least ten to 12 weeks after a second dose was received as part of the ongoing vaccination programme.
Vaccines being trialled include Oxford/AstraZeneca, Pfizer/BioNTech, Moderna, Novavax, Valneva, Janssen and Curevac, as well as a control group.
Initial findings are expected in September and will help inform decisions by the Joint Committee on Vaccination and Immunisation (JCVI) on plans for a booster programme from autumn this year.
“We will do everything we can to future-proof this country from pandemics and other threats to our health security, and the data from this world-first clinical trial will help shape the plans for our booster programme later this year,” commented health secretary Matt Hancock.
Medicago and GlaxoSmithKline’s (GSK) plant-derived COVID-19 vaccine has generated some promising mid-stage trial results, the companies revealed today.
Interim results from a Phase II trial evaluating the vaccine candidate, which is being tested in combination with GSK’s pandemic adjuvant, found that neutralising antibody responses were ten times higher in vaccinated participants compared to people recovering from COVID-19. In addition, similar antibody responses were observed in both adults (aged 18-64 years) and the elderly (aged 65 and older) after two doses.
The companies also reported that no related severe adverse events were seen in the trial and that reactogenicity was generally mild-to-moderate and short in duration.
Elsewhere, an experimental vaccine being developed by Sanofi and GSK generated “strong immune responses across all adult age groups” in a Phase II trial.
In the study, the jab achieved high rates of neutralising antibody responses, similar to those measured in people who have recovered from COVID-19, in all adult age groups. The results showed 95% to 100% seroconversion following second injections in all age groups – 18 to 95 years old – and across all doses tested.
Sanofi/GSK added that high neutralising antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection after a single injection, suggesting a ‘strong’ potential for its development as a booster jab.