Saturday, 12 September 2020
The American pharmaceuticals giant Merck has announced it will begin a clinical trial in Belgium of its vaccine against Covid-19.
The trial will involve 260 subjects and be run by SGS Life Sciences, based in Antwerp. The majority of subjects should be aged 18 to 55, but part of the trial will concentrate on subjects aged 60 or over.
Subjects in the 18-55 group will receive two ascending doses (in other words, the second dose is stronger than the first) of the vaccine or placebo in phase one on day one and day 57 of the trial. In phase two they will receive either one dose on day one or two doses on day one and day 169.
In the 60+ age group, the procedure is the same.
Both vaccine and placebo (0.9% saline) are administered by intra-muscular injection.
The criteria for being accepted include overall good, health, BMI less than 30, not infected with Covid and practising social distancing, not pregnant or breast-feeding, and women must take a pregnancy test.
The inclusion criteria also state: “Male participants are eligible to participate if they agree to refrain from donating sperm, be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or agree to use contraception during the intervention period and for at least 6 months after the last dose of study intervention.”
The trial will run until April 2022, although it could be finished sooner, Merck said. Anyone wishing to volunteer to take part should have their GP contact the study coordinator at SGS, telephone +32 3 217 2560, citing NCT identifier NCT04498247.
The Brussels Times