| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
healthy volunteers
active immunization for the prevention of Chikungunya virus infection |
|
| E.1.1.1 | Medical condition in easily understood language |
| A vaccine that helps protect people from getting sick from the chikungunya virus. Chikungunya is a virus infection that people can get from mosquito bites. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10067256 |
| E.1.2 | Term | Chikungunya virus infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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. |
|
| E.2.2 | Secondary objectives of the trial |
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
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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) |
|
| E.4 | Principal 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 members. Dependent relationships included close relatives (i.e., children, partner/spouse, siblings, parent(s)/LAR[s]) as well as employees of the Investigator or site personnel conducting the trial. |
|
| E.5 End points |
| E.5.1 | 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. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| within 14 days post-vaccination |
|
| E.5.2 | 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. |
|
| E.5.2.1 | 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, 85, 180 and at Month 12 post-vaccination
I5. at Day 15, Day 29, Day 85, Day 180 and Month 12
I6. at Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| observer blind, with sentinel enrollment in open-label fashion |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
| Dominican Republic |
| Honduras |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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