Chikungunya Clinical Trial
Official title:
A Randomized, Observer-Blinded, Dose-Escalation Phase 1 Study to Assess the Safety and Immunogenicity of Three Different Dose Levels of a Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers Aged 18 To 45 Years
Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study
investigating three dose levels of VLA1553 after a single immunization.
120 study participants will be enrolled into the study to receive three different doses (30
subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be
given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of
20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a
blinded, randomized manner in the three study arms.
A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination
will be sufficient to induce high titer neutralizing antibodies and protect subjects from
CHIKV viremia.
Study participants will be followed up until 13 months after initial vaccination.
n/a
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