Clinical trial MV-CHIK-205 is designed to investigate the safety, tolerability, and long-term immunogenicity of a novel vaccine designed to protect against chikungunya virus, a mosquito-borne pathogen causing chikungunya fever throughout tropical areas worldwide.
- Conditions
- The study is being conducted in healthy volunteers for the prophylaxis of chikungunya virus (CHIKV) infection.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-000211-25-GB
- Lead Sponsor
- Themis Bioscience GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate immunogenicity and safety of MV-CHIK in different dose regimens, 28 days<br>after one or two vaccinations;Secondary Objective: • To compare immunogenicity, safety and tolerability between different doses and<br>formulations of MV-CHIK during the treatment period up to day 56<br>• To investigate the immunogenicity and safety of a novel liquid vaccine formulation<br>• To evaluate cellular responses induced by one or two immunisations<br>• To evaluate the long-term immunogenicity of MV-CHIK up to one year after the first<br>MV-CHIK treatment.<br>• To collect human sera for future efficacy evaluation, by passive transfer of<br>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 Outcome Measures
Name Time Method Secondary end point(s): • Rate of solicited and unsolicited adverse events during the treatment period until day 56<br>• Serious adverse events during the treatment period until study day 56<br>• Immunogenicity on days 0, 28 (group A, B, C, and D), days 0, 56 (group E) and long-term<br>immunogenicity on day 182 (6 Mo) and 365 (12 Mo), confirmed by the presence of<br>functional antibodies as determined by the plaque reduction neutralisation test (PRNT50).<br>• Measurement of anti-Chikungunya antibodies on days 0, 28, 56, 182 and 365 determined<br>by enzyme linked immunosorbent assay (ELISA)<br>• Measurement of anti-Measles antibodies on days 0, 28, 56 determined by enzyme linked<br>immunosorbent assay (ELISA)<br>• Induction of Chikungunya specific immune responses on days 0, 14, 28, 42 and 56<br>determined by T-cell assay.;Timepoint(s) of evaluation of this end point: Please see E.5.2.