The study is being conducted in healthy volunteers for the prophylaxis of chikungunya virus (CHIKV) infection.
Conditions
Interventions
Product Name: MV-CHIK
Pharmaceutical Form: Lyophilisate and suspension for suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: I
Sponsors
Themis Bioscience GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent obtained before any trial-related activities 2. Healthy men or women aged 18 to 55 years on the day of consenting 3. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study 4. All female subjects must have a negative serum pregnancy test at screening 5. Willingness not to become pregnant or to father a child during the entire study period by practicing reliable methods of contraception as specified in protocol section 8.11.4 6. Availability during the duration of the trial 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical study (including exposure to an investigational medicinal product ore device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period (day 56) 2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection 3. History of drug addiction including alcohol dependence within the last 2 years 4. Inability or unwillingness to avoid intake of more than around 20g alcohol per day during 48 hours after each vaccination (equals roughly 0.5 L beer or 0.25 L of wine) 5. Vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until end of treatment period (day 56) 6. Prior receipt of any Chikungunya vaccine 7. History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit 8. Recent infection within 1 week prior to Screening Visit (possibility of deferral) 9. Blood donations including plasma donations, 90 days prior to Screening Visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until end of treatment period (day 56) 10. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study 11. History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any haematological malignancy 12. Behavioural, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol 13. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine 14. History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer 15. Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female subjects. (Prior to taking any medication within 72 h before study vaccination, the subject should consult the investigator) 16. Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to the first vaccination or anticipated use before completion of the treatment period (day 56) 17. Receipt of blood products or immunoglobulins within 120 days prior to the Screening Visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period (day 56) 18. Pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period 19. Unreliable contraception methods (for details please refer to protocol section 8.11.4) 20. Persons in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate immunogenicity and safety of MV-CHIK in different dose regimens, 28 days after one or two vaccinations;Secondary Objective: • To compare immunogenicity, safety and tolerability between different doses and formulations of MV-CHIK during the treatment period up to day 56 • To investigate the immunogenicity and safety of a novel liquid vaccine formulation • To evaluate cellular responses induced by one or two immunisations • To evaluate the long-term immunogenicity of MV-CHIK up to one year after the first MV-CHIK treatment. • To collect human sera for future efficacy evaluation, by passive transfer of anti-Chikungunya antibodies to virus susceptible non-human primates;Primary end point(s): Immunogenicity 28 days after the last MV-CHIK vaccination confirmed by the presence of functional antibodies as determined by the plaque reduction neutralisation test (PRNT50).;Timepoint(s) of evaluation of this end point: Please see E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Rate of solicited and unsolicited adverse events during the treatment period until day 56 • Serious adverse events during the treatment period until study day 56 • Immunogenicity on days 0, 28 (group A, B, C, and D), days 0, 56 (group E) and long-term immunogenicity on day 182 (6 Mo) and 365 (12 Mo), confirmed by the presence of functional antibodies as determined by the plaque reduction neutralisation test (PRNT50). • Measurement of anti-Chikungunya antibodies on days 0, 28, 56, 182 and 365 determined by enzyme linked immunosorbent assay (ELISA) • Measurement of anti-Measles antibodies on days 0, 28, 56 determined by enzyme linked immunosorbent assay (ELISA) • Induction of Chikungunya specific immune responses on days 0, 14, 28, 42 and 56 determined by T-cell assay.;Timepoint(s) of evaluation of this end point: Please see E.5.2. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Study Manager
Themis Bioscience GmbH
Outcome results
None listed