Prevention against Lyme borreliosis MedDRA version: 20.0 Level: PT Classification code 10025169 Term: Lyme disease System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10025170 Term: Lyme's disease System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10067559 Term: Lyme borreliosis System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Valneva Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is aged 18 to 65 years at the day of screening (Visit 0); 2. Subject is of good general health, including subjects with pharmacologically controlled chronic conditions; 3. Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures; 4. If subject is of childbearing potential: a) Subject has a negative serum pregnancy test at screening (Visit 0); b) Subject agrees to employ adequate birth control measures for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to Visit 0; 2. Subject received previous vaccination against LB; 3. Subject had a tick bite within 4 weeks prior to Visit 1; 4. Subject has a medical history of or currently has a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible; 5. Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome; 6. Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to first vaccination or until Day 57 (Visit 3), contraindicating I.M. vaccination as judged by the investigator; 7. Subject has received an active or passive immunization within 28 days before first vaccination at Visit 1 and until Day 85; except for influenza (seasonal or pandemic) and pneumococcal vaccines which may be administered outside a 7-days interval before or after any trial vaccination; 8. Subject has received any other non-registered medicinal product in another clinical trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and throughout the entire study period or has received a registered medicinal product in another clinical trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and up to Day 85; 9. Subject has a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), status post organ transplantation or immuno-suppressive therapy within 30 days prior to Visit 1. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent greater or equal 0.05 mg/kg/day. Topical and inhaled steroids are allowed; 10. Subject has a history of anaphylaxis or severe allergic reactions or a known hypersensitivity or allergic reactions to one of the components of the vaccine; 11. Subject had any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled; 12. Subject had acute febrile infections within 10 days prior to first vaccination; 13. Subject is pregnant (positive serum pregnancy test at screening), has plans to become pregnant during the course of the study or is lactating at the time of enrollment. Women of childbearing potential that are unwilling or unable to employ an adequate birth control measure for the duration of the study. 14. Subject has donated blood or blood-derived products (e.g. plasma) within 30 days or received blood or blood-derived products (e.g. plasma) within 90 days prior to first vaccination in this study or plans to donate or use blood or blood products during the course of the study; 15. Subject has any condition that, in the opinion of the investigator, may compromise the subject’s well-being, might interfe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the optimal dose of VLA15 in healthy adults aged 18 - 65 years up to Day 85.;Secondary Objective: To assess the immune response of VLA15 in healthy adults aged 18 - 65 years up to Month 12 (i.e. 10 months after the primary vaccination series) To assess the safety profile of VLA15 in healthy adults aged 18 - 65 years up to Month 12.;Primary end point(s): GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6, determined by ELISA ;Timepoint(s) of evaluation of this end point: at Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity: 1.GMTs for IgG against each OspA serotype (ST1 to ST6), determined by ELISA 2.SCRs (Seroconversion Rate, defined as four-fold increase in IgG titer compared to baseline) for each OspA serotype specific IgG (ST1 to ST6), determined by ELISA 3.GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6), determined by ELISA 4. GMTs, SCRs and GMFRs for IgG against each OspA serotype (ST1 to ST6), determined by ELISA Safety: 1. Frequency of SAEs 2. Frequency of related SAEs 3. Frequency of AESIs 4. Frequency of related AESIs 5. Frequency of unsolicited AEs 6. Frequency of related unsolicited AEs 7. Frequency of solicited local and solicited systemic AEs 8. Frequency of SAEs, AESIs, solicited and unsolicited AEs stratified by age group;Timepoint(s) of evaluation of this end point: Immunogenicity: 1. at Day 1, 29, 57, 180, 236, and Month 12 2. at Day 29, 57, 85, 180, 236, and Month 12 3. at Day 29, 57, 85, 180, 236, and Month 12 4. at Day 1, 29, 57, 85, 180, 236, and Month 12 Safety: 1. to 6. during the entire study 7. within 7 days after each and after any vaccination 8. during the entire study | — |
Countries
Austria, Belgium, Germany, United States
Contacts
Public ContactValneva Clinical Operations
Valneva Austria GmbH
Outcome results
None listed