Chikungunya Virus Infection
Conditions
Interventions
Placebo
Sponsors
VALNEVA AUSTRIA GMBH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged 12 years of age or above. (around 1,000 participants 12 to < 18 years of age will be enrolled.) 2. Participants must be able to provide signed informed consent/assent (and LAR must provide informed consent, if applicable), 3. Participants who are willing and able to comply with laboratory tests and health care visits, lifestyle considerations and other trial procedures. 4. Participants residing in the selected areas of the selected country where the trial will be conducted. 5. Participants without evidence of CHIKV-specific IgM and IgG antibodies at recruitment. 6. If participant is of childbearing potential: a. Participants have practiced an adequate method of contraception during the 30 days before Day 1; b. Participant has a negative urine pregnancy test at Day 1; c. Participant agrees to employ adequate birth control measures for the first three months post IP administration (i.e. until Day 85).
Exclusion criteria
Exclusion criteria: 1.Participant is pregnant, lactating or intends to become pregnant within three months post IP administration. Male participant who intends to father a child within 3 months following vaccination or does not agree to employ adequate birth control measures during the first 3 months after vaccination. 2.Participants have any known medical or psychiatric conditions, or laboratory abnormalities within the past year, or current presence of an acute or progressive, unstable or uncontrolled clinical condition that could elevate the risks associated with trial participation. 3.Febrile illness (temperature = 38.0°C/100.4°F) or moderate or severe acute illness/infection within 72 hours prior to IP administration. 4.Individuals with a known history of severe allergic reaction to any component of the VLA1553 vaccine. 5.Immunodeficient or immunosuppressed individuals due to disease or medical therapy or participants with known HIV infection with a known CD4+ lymphocyte count =200/µL or CD4+ percentage <14% and/or a known viral load of =50 copies/mL). 6.Individuals with a self-reported history of immune-mediated or clinically relevant arthritis/arthralgia, autoimmune diseases requiring therapeutic intervention or history of malignancy in the past 5 years. 7.Individuals with a history of underlying cardiac arrhythmias. 8.Current alcohol abuse or drug addiction. 9.Receipt of monoclonal antibodies with potential immunomodulatory effects or blood-derived products (immunoglobulins, hyperimmune globulins, plasma, whole blood, or platelet transfusions) within 12 weeks prior to IP administration, or planned receipt within 30 days post-IP administration. 10.Individuals having previously received an investigational or licensed vaccine against chikungunya. 11.Individuals employed at trial centre or by Investigator, who have direct involvement in this, or other trials led by the same Investigator or centre. Immediate family members of such employees or the Investigator are also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of acute symptomatic virologically confirmed CHIKV infection (starting at Day 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of acute symptomatic virologically confirmed CHIKV infection (starting at Day 1);Occurence of chronic chikungunya as per definition;Occurrence of severe chikungunya-like adverse reactions (ARs) within 30 days after vaccination.;Occurrence of solicited adverse events (AEs) which constitute safety concerns during specific time-collection windows post-vaccination.;Occurrence of unsolicited AEs throughout the trial.;Occurrence of SAEs throughout the trial. | — |
Countries
Kenya
Contacts
Public ContactVALNEVA Austria GmbH
Public enquiries
Outcome results
None listed