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 Half Dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
Product Code: VLA1553
Pharmaceutical Form: Lyophilisate for solution for injection
Product Name: CHIKV vaccine
Sponsors
Valneva Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female healthy children aged 7 to 11 years for Stratum A, 3 to 6 years for Stratum B and 1 to 2 years for Stratum C at the time of vaccination; 2. Written informed consent by the participant’s parent(s)/Legally Acceptable Representative(s) ((LAR(s)), according to local requirements, and written informed assent of the participant, if applicable; 3. Participant was seropositive for previous CHIKV exposure (i.e., IgM+/IgG+ or IgM-/IgG+) or seronegative (i.e., IgM-/IgG-); or participants with any borderline IgM or IgG element (IgM borderline/IgG-, IgM-/IgG borderline, or IgM borderline/IgG borderline were mapped to seronegative group; participants with enzyme-linked immunosorbent assay (ELISA) result IgM borderline/IgG+ were mapped to seropositive group) Are the trial subjects under 18? yes Number of subjects for this age range: 300 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: 1. Participant who was anti-CHIKV IgM+/IgG- or IgM+/IgG borderline did not qualify for participation in this trial. 2. Participant was taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or had participated in a clinical trial involving an investigational CHIKV vaccine; 3. Participant had an acute or recent infection (and was not symptom-free in the week prior to the Screening Visit (Visit 0) 4. Participant had received another live virus vaccine within 28 days or inactivated vaccine (includes messenger ribonucleic acid [mRNA] vaccines) within 14 days prior to vaccination in this trial or planned to receive a live virus vaccine within 28 days or inactivated vaccine within 14 days after vaccination; 5. Participant had abnormal findings in any required trial investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which posed a risk for participation in the trial based on his/her judgment; 6. Participant had an ongoing medical history of or currently had acute or progressive, unstable or uncontrolled clinical conditions (e.g., cardiovascular, respiratory, neurologic, psychiatric, or rheumatologic conditions) that posed a risk for participation in the trial, based on Investigator’s clinical judgment. Examples included individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment, or presence of high-risk comorbidities (e.g., significant cardiopulmonary disease); 7. Participant had a history of immune-mediated or clinically relevant arthritis/arthralgia; 8. Participant had a known or suspected defect of the immune system that could be expected to influence the immune response to the vaccine, such as Participants with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno- suppressive therapy within 4 weeks prior to Visit 1. Immunosuppressive therapy was defined as administration of chronic (longer than 14 days) prednisone or equivalent =0.05 mg/kg/day within 4 weeks prior to trial entry, radiation therapy or immunosuppressive cytotoxic drugs/ monoclonal antibodies in the previous 3 years; topical and inhaled steroids were allowed. 9. Participant had a history of any vaccine-related contraindicating event (e.g., anaphylaxis, allergy to components of the vaccine or the control vaccine, other known contraindications including febrile convulsions); 10. Participant presented with clinical conditions representing severe bleeding disorders and medications interfering with blood clotting; 11. Participant received blood-derived products (e.g. plasma) within 180 days prior to vaccination in this trial; 12. Participant had participated in another clinical trial involving an investigational medicinal product (IMP) or device within 30 days prior to vaccination or was scheduled to participate in another clinical trial involving an IMP, or device during the course of this trial; 13. Participant had any condition that, in the opinion of the Investigator, could compromise the participant’s well-being, might interfere with evaluation of trial endpoints, or would limit the participant’s ability to complete the trial; 14. Participant/ Participant’s parent(s)/LAR(s) was/were a member of the team conducting the trial or in a dependent relationship with one of the trial team mem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the tolerability of the full dose and half dose formulation of the live-attenuated CHIKV vaccine (VLA1553) following vaccination in healthy children aged 1 to 11 years after a single immunization.;Secondary Objective: 1. To assess the safety of the full dose and half dose formulation of VLA1553 in healthy children aged 1 to 11 years after a single immunization 2. To identify the optimal dose level(s) of VLA1553 in healthy children aged 1 to 11 years. 3. To assess the immunogenicity of the full dose and half dose formulation of VLA1553 in healthy children aged 1 to 11 years after a single immunization ;Primary end point(s): The primary endpoint is to assess tolerability through the frequency and severity of solicited injection site and systemic reactions within 14 days post-vaccination.;Timepoint(s) of evaluation of this end point: within 14 days post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety S1. Frequency and severity of any adverse event (AE); S2. Frequency and severity of unsolicited AE; S3. Frequency and severity of any serious adverse event (SAE); S4. Frequency and severity of any early onset adverse event of special interest (AESI); S5. Frequency and severity of any late onset adverse event of special interest (AESI); S6. Assessment of viremia; Immunogenicity I1. Immune response in baseline seronegative participants as measured by CHIKV-specific neutralizing antibody titers as determined by µPRNT assay; I2. Proportion of participants with seroconversion as compared to baseline as determined by µPRNT assay; I3. Proportion of participants with a seroresponse (defined as µPRNT50 =150 for baseline negative participants) as determined by µPRNT assay; I4. Fold increase of CHIKV-specific neutralizing antibody titers determined by µPRNT assay as compared to baseline; I5. Proportion of participants reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titers compared to baseline as measured by µPRNT assay; I6. Antibody titers, seroresponse, seroconversion and fold increases for CHIKV-specific neutralizing antibodies, determined by µPRNT assay stratified by baseline serostatus (based on µPRNT), age stratum and dose.;Timepoint(s) of evaluation of this end point: Safety S1. within 28 days post-vaccination S2. until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination S3. until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination S4. starting within 2 to 21 days post-vaccination (i.e. Day 3 – Day 22) S5. during the entire trial starting 22 days post-vaccination (i.e. Day 23 – trial end) S6. on Days 1, 4, 8, and 15 and beyond as applicable Immunogenicity I1. on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination I2. at Day 15, Day 29, Day 85, Day 180 and Month 12 I3. on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination I4. at Days 15, 29, | — |
Countries
Dominican Republic, Honduras
Contacts
Public ContactStudy Director
Valneva Austria GmbH
Outcome results
None listed