healthy volunteers active immunization for the prevention of Chikungunya virus infection MedDRA version: 20.1 Level: PT Classification code 10067256 Term: Chikungunya virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: CHIKV vaccine
Product Code: VLA1553
Pharmaceutical Form: Lyophilisate for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the
Sponsors
Instituto Butantan (Principal Sponsor in Brazil)
Valneva Austria GmbH (Development lead and Co-Sponsor)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female adolescents from the 12th birthday to the last day before the 18th birthday at the time of vaccination; - written informed consent by the subject’s legal representatives, and written informed assent of the subject; - generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests; - seropositive for previous CHIKV exposure (i.e. IgM+/IgG+ or IgM-/IgG+) or seronegative (i.e. IgM-/IgG-) as screened by CHIKV-specific ELISA. - for women of childbearing potential: - negative serum or urine pregnancy test at screening and on Day 1. - practiced an adequate method of contraception during 30 days before screening - agreed to employ adequate birth control measures for the first three months post-vaccination (i.e. until Day 85). Are the trial subjects under 18? yes Number of subjects for this age range: 750 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - was taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or had participated in a clinical study involving an investigational CHIKV vaccine; - acute or recent infection; - tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); - abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which pose a risk for participation in the study; - medical history of or currently had acute or progressive, unstable or uncontrolled clinical conditions that posed a risk for participation in the study; - history of immune-mediated or clinically relevant arthritis / arthralgia; - history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there had been surgical excision or treatment more than 5 years ago that was considered to have achieved a cure, the subject could be enrolled;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate immunogenicity and safety of the full dose of the live-attenuated CHIKV vaccine candidate (VLA1553) 28 days following vaccination in adolescents aged 12 years to <18 years after a single immunization.;Secondary Objective: To assess the immunogenicity and safety of the full dose of VLA1553 following vaccination in adolescents aged 12 years to <18 years after a single immunization up to Month 12. To assess the immunogenicity and safety of VLA1553 in subjects previously exposed to chikungunya virus.;Primary end point(s): Proportion of subjects with a seroprotective CHIKV antibody level defined as µPRNT50 = 150 for µPRNT baseline negative subjects 28 days post-vaccination.;Timepoint(s) of evaluation of this end point: 28 days after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity: I1. Immune response as measured by CHIKV-specific neutralizing antibody titers on Day 8, Day 29, Day 85, Day 180, and Month 12 post-vaccination as determined by µPRNT assay; I2. Proportion of subjects with seroprotective levels (defined as µPRNT50 = 150 for µPRNT baseline negative subjects) on Day 8, Day 85, Day 180 and Month 12 post-vaccination as determined by µPRNT assay; I3. Proportion of subjects with seroconversion (defined as >4-fold increase of µPRNT50 compared to baseline) at Day 29, Day 180 and Month 12 post-vaccination as determined by µPRNT assay; I4. Fold increase of CHIKV-specific neutralizing antibody titers determined by µPRNT assay at Days 8, 29, 85, 180 and at Month 12 post-vaccination as compared to baseline; I5. Proportion of subjects reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline as measured by µPRNT assay; I6. Antibody titers, seroprotection and fold increases for CHIKV-specific neutralizing antibodies, determined by µPRNT assay at Days 1, 8, 29, 85, 180, and Month 12 post-vaccination stratified by µPRNT baseline serostatus. Safety: S1. Frequency and severity of unsolicited AEs until Day 29 and Month 6 post-vaccination; S2. Frequency and severity of solicited injection site and systemic reactions within ten days post-vaccination; S3. Frequency and relatedness of any serious adverse event (SAE) during the entire study period; S4. Frequency and severity of any early onset adverse event of special interest (AESI) starting within 2 to 21 days post-vaccination (i.e. Day 3 – Day 22); S5. Frequency and severity of any late onset adverse event of special interest (AESI) during the entire study starting 22 days post-vaccination (i.e. Day 23 – study end); S6. Assessment of viremia on Days 1 and 8 (and Day 29, if applicable) after vaccination.;Timepoint(s) of evaluation of this end point: Immunogenicity: I1. on Day 8, Day 29, Day | — |
Countries
Brazil
Contacts
Public ContactStudy Director
Valneva Austria GmbH
Outcome results
None listed