Facemask, vaccine vial, and syringe

COVID-19 continues to dominate the infectious disease clinical trial landscape

We review recently announced late-stage clinical development plans in the infectious disease arena.

By Urtė Fultinavičiūtė, Clinical Trials Arena

Covid-19 is still a trending indication as per recently announced Phase III trials in infectious diseases. According to GlobalData’s Clinical Trial Database, six out of the 11 planned trials disclosed in the last two weeks will be investigating Covid-19 boosters and therapeutics. GlobalData is the parent company of Clinical Trials Arena. As for other indications, monkeypox, shingles, molluscum contagiosum, sepsis and gram-negative bacterial infections also appear in this recently announced Phase III trial pipeline.

mRNA boosters head-to-head

Everest Medicines is planning to investigate its PTX-COVID19-B as a booster shot with the trial starting in February 2023. The active-control study (NCT05534048) will recruit 3800 participants into efficacy and safety cohorts.

The efficacy cohort will include patients who previously received two doses of Pfizer-BioNTech’s Comirnaty vaccine three months prior. All subjects will receive a dose of either Comirnaty or PTX-COVID19-B.

The safety cohort will have subjects who received any primary doses of vaccines approved by WHO Emergency Use Authorisation three months prior, or already received authorised booster jabs and planned to receive PTX-COVID19-B as their fourth shot. All participants in the safety cohort will receive one dose of the investigational booster.

The trial will be about six months long for each participant, with estimated end date in July 2023. PTXCOVID-19B is an mRNA vaccine. The primary endpoints will evaluate the non-inferiority to Comirnaty and assess the safety profile. Read more …