Study design and participants
dengue, hypersensitivity, CHUV, flavivirus infection
SARS-COV-2 INFECTION, DENGUE, JAPANESE ENCEPHALITIS, WEST NILE VIRUS, TICK-BORNE ENCEPHALITIS, YELLOW FEVER, HYPERSENSITIVITY
naNO-DENGUE was a single-centre, vehicle-controlled, randomized, double-blind, dose-finding phase 1 trial to assess the safety and immunogenicity of PepGNP-Dengue (low dose [LD] and high dose [HD]), administered in two doses 21 days apart.The study took place in a non-dengue endemic setting, at the Centre for primary care and public health and Clinical Trial Unit of the Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland. Participants were recruited through advertisements posted in communication networks of local academic and hospital institutions. Eligible participants were healthy men and women aged 18–45 years residing in Switzerland, with normal clinical and laboratory findings at the screening visit. Exclusion criteria included: history of flavivirus infection or previous vaccination against Japanese encephalitis, yellow fever, or dengue; past residence or planned trip during the trial to a highly endemic region for flavivirus (excepting tick-borne encephalitis [TBE] and West Nile virus); hypersensitivity to gold; pregnant or lactating women, or those with childbearing potential. Since the study took place at a time of high prevalence of SARS-CoV-2 infections, if there was a clinical suspicion of COVID-19 on the days of vaccination, the participant was required to undergo a SARS-CoV-2 PCR or rapid antigen test, with vaccination delayed until a negative result was confirmed. The comprehensive list of inclusion and exclusion criteria is detailed in 