The National Institutes of Health (NIH) has launched a pilot Phase II clinical trial to analyse antibody response to a third dose of an authorised mRNA Covid-19 vaccine in kidney transplant recipients who had no response to two Moderna or Pfizer-BioNTech vaccine doses. The CPAT trial will recruit up to 200 adult participants aged 18 years and above. The trial expects to report initial data next month, and will inform a subsequent larger trial of increased risk strategies to trigger an immune response against SARS-CoV-2 in solid organ transplant recipients not responding to a third mRNA vaccine dose.
Merck has received provisional determination from Australia’s Therapeutic Goods Administration (TGA) for molnupiravir, an oral antiviral single agent, to treat adults with Covid-19. The provisional determination makes Merck eligible to file for provisional registration of the drug in the country. Molnupiravir targets SARS-CoV-2 replication and is thought to possess broad-spectrum activity against various RNA viruses.
South Korea-based SK bioscience has announced plans to conduct a Phase III clinical trial of its Covid-19 vaccine, GBP510, which was developed in alliance with the University of Washington’s Institute for Protein Design and adjuvanted with GlaxoSmithKline’s pandemic adjuvant system. The Phase III trial comes after favourable interim results from a Phase I/II trial, which showed neutralising antibodies against SARS-CoV-2 in all subjects who received the adjuvanted vaccine.