Viral infection
Conditions
Interventions
Subjects will receive the VLA1553 vaccine by intramuscular administration. The VLA1553 vaccine is a registered vaccine, containing 1 x 10^4 50% Tissue Culture Infective Dose (TCID50) of live attenuate
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Signed informed consent prior to any study-mandated procedure Healthy male or female volunteers, 18 to 64years of age (inclusive) at screening A total body weight =50 kg and body mass index (BMI) =18.0 and =32.0 kg/m2 at screening; All women of childbearing potential must practice effective contraception during the course of the study and until the last study visit (Day 60); Subject is able to communicate well in Dutch with the investigator, has adequate understanding of the procedures of the study and is willing to comply with the study procedures and restrictions;
Exclusion criteria
Exclusion criteria: Any history or evidence of any clinically significant or currently active major disease, or condition that, in the opinion of the investigator, may interfere with a subject completing the study and the necessary investigations (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, and body temperature) and ECG). Minor deviations from the normal range may be accepted, if judged by the investigator to have no clinical relevance; Any confirmed or suspected disease or condition associated with immune system impairment, including auto-immune diseases, HIV, asplenia or recurrent severe infections; (History of) confirmed or suspected rheumatic disease or condition associated with joint inflammation or clinically significant arthritis/arthralgia. Suspected or confirmed history of infection with Chikungunya; Prior participation in another controlled human infection study with Chikungunya, Yellow Fever or Dengue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Infection rate: number of healthy volunteers developing viremia divided by the number of healthy volunteers receiving the vaccine - Sumptomatic rate: number of healthy volunteers developing vaccine related symptoms divides by the number of healthy volunteers receiving the vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Nature, frequency and severity of (serious) adverse events; - Vital signs; - Vaccine related symptoms; - Clinical laboratory tests including hematology and chemistry; - Physical examination, symptom directed and on indication; - Concomitant medication; - Local tolerability of injection site as assessed by a numeric rating scale (NRS). - Chikungunya viral load (in both blood and urine) over time as determined by qPCR. - Chikungunya viral culture titer, determined by plaque assay, over time. - Severity, duration and nature of solicited and unsolicited vaccine related symptoms. - Occurrence of leukopenia and lymphopenia after administration of the VLA1553 vaccine. - Seroconversion rate: number of healthy volunteers developing virus neutralizing antibodies divided by the number of healthy volunteers receiving the vaccine; - Titer of virus neutralizing antibodies. | — |
Countries
Netherlands
Contacts
Public ContactI.M.C. Visser-Kamerling
Centre for Human Drug Research
Outcome results
None listed