Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02861586
• Date of registration: 28/07/2016
• Prospective Registration: Yes
• Primary sponsor: Themis Bioscience GmbH
• Public title: Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine MV-CHIK-202
• Scientific title: Double Blinded, Randomized, Priorix®- and Placebo-controlled, Trial to Evaluate the Optimal Dose of MV-CHIK Vaccine (Against Chikungunya Virus) in Regard to Immunogenicity, Safety and Tolerability in Healthy Volunteers
• Date of first enrolment: August 17, 2016
• Target sample size: 263
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02861586
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Austria, Germany

Contacts

• Name: Thomas Jelinek, MD
• Affiliation: Berliner Centrum für Reise- und Tropenmedizin

• Name: Fritz Pinl, MD
• Affiliation: Hansa Sanatorium GmbH, Graz

• Name: Emil Reisinger, MD
• Affiliation: Medical University Rostock

• Name: Christa Firbas, MD
• Affiliation: Medicinal University Vienna

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed informed consent obtained before any trial-related activities.

2. 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

3. Available for the duration of the trial

4. Healthy men or women aged >18 and <55 years

5. In female subjects either childbearing potential terminated by surgery or one year
post-menopausal, or a negative urine pregnancy test during screening and the
willingness not to become pregnant during the entire study period by practicing
reliable methods of contraception as specified in protocol

6. Normal findings in medical history and physical examination or the investigator
considers all abnormalities to be clinically irrelevant

7. Normal laboratory values or the investigator considers all abnormalities to be
clinically irrelevant (unless otherwise specified in exclusion criteria)

Exclusion Criteria:

1. Participation in another clinical study within the past month in which the subject has
been exposed to an investigational product (pharmaceutical product or placebo or
device) or planned concurrent participation in another clinical study during the study
period

2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection,
current hepatitis B/C infection,

3. Drug addiction including alcohol dependence

4. Inability or unwillingness to avoid more than the usual intake of alcohol during the
48 hours after vaccination (not more than 20g alcohol per day, which equals 0.5 L beer
or 0.25 L of wine)

5. Persons who are accommodated in an institution on court or official order.

6. Persons in direct relationship with the sponsor, an Investigator or other study site
staff. Direct relationship includes relatives or close dependents (children,
spouse/partner, siblings or parents), as well as employees (site or sponsor).

7. Non-study licensed vaccines: vaccination within 4 weeks prior to first vaccination or
planning to receive any non-study vaccine during the study period.

8. Measles vaccination or booster within the last 5 years or during the clinical study

9. Prior receipt of any Chikungunya vaccine

10. Blood donations during 1 month prior to Screening Visit and throughout the study

11. Recent infection (within 1 week prior to Screening Visit) (If non-serious, can be
basis for temporary deferral)

12. Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory,
skin, hematological, endocrine, inflammatory or neurological diseases, that in the
opinion of the investigator may interfere with the aim of the study

13. History of neoplastic disease (excluding non-melanoma skin cancer that was
successfully treated) within the past 5 years or a history of any hematological
malignancy.

14. History of autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus
(SLE), autoimmune thyroid disease).

15. History of moderate or severe arthritis or arthralgia within the past 3 months prior
to Screening Visit.

16. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator
affects the ability of the participant to understand and cooperate with the study
protocol.

17. 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.

18. History of anaphylaxis to drugs or major allergic reactions in general, which the
investigator considers may compromise the safety of the volunteers

19. Clinically relevant abnormal laboratory values indicative of physical illness

- Hematology: hemoglobin, hematocrit, erythrocyte count, differential white blood
count, platelets

- Chemistry: creatinine (=1.7 mg/dL), potassium, sodium, calcium, aspartate
transaminase/alanine aminotransferase (AST/ALT) = 2.6 upper limit of normal
(ULN), alkaline phosphatase, bilirubin

- Coagulation parameter: prothrombin time (PT), activated partial thromboplastin
time (aPTT), fibrinogen according to the evaluation of the principle investigator

- Urinalysis according to the evaluation of the principle investigator

20. Use of medication during 2 weeks before the first vaccination and throughout the
study, which the investigator considers may affect the validity of the study except
hormonal contraception in female subjects; prior to taking any medication during 72 h
prior to the first vaccination, the study center should be consulted.

21. Immunosuppressive drugs: use of corticosteroids (excluding topical preparations) or
immunosuppressive drugs within 30 days prior to vaccination, or anticipated use during
the trial.

22. Receipt of blood products or immunoglobulins within 120 days prior to Screening Visit
or anticipated receipt of any blood products or immunoglobulin during the trial.

23. Pregnancy (positive pregnancy test at screening or during study phase), lactation or
unreliable contraception in female subjects with child-bearing potential (for details
please refer to section 8.3.6)

24. Subjects with any condition which in the opinion of the investigator makes the subject
unsuitable for inclusion

25. Individuals who are living and/or working with severely immunocompromised people,
children under 15 months old or pregnant women.

26. Inability or unwillingness to provide informed consent and to abide by the
requirements of the study

27. Refusal to allow storage of specimens for future research.

28. Regular blood plasma donations



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chikungunya Virus Infection

Intervention(s)

Biological: physiological saline solution

Biological: Priorix®

Biological: MV-CHIK low dose

Biological: MV-CHIK high dose

Primary Outcome(s)

Immunogenicity on day 56 confirmed by plaque reduction neutralization test (PRNT50) [Time Frame: Study day 56 (e.g. 28 days after one or two vaccinations depending on treatment group).]

Secondary Outcome(s)

Serious adverse events [Time Frame: Randomization until study day 224]

Shedding of live recombinant virus until day 196 [Time Frame: Baseline until study day 196]

Immunogenicity confirmed by the presence of functional anti-chikungunya antibodies, determined by the plaque reduction neutralization test (PRNT50) [Time Frame: Baseline until study day 224]

Immunogenicity confirmed by the presence of functional anti-chikungunya antibodies, determined by enzyme linked immunosorbent assay (ELISA) [Time Frame: Baseline until study day 224]

Number of subjects with clinically relevant, abnormal laboratory values [Time Frame: Screening until study day 224]

Pre-existing anti-vector immunity [Time Frame: Baseline until study day 224]

Chikungunya virus specific T cell responses [Time Frame: Baseline until study day 224]

Rate of adverse events during the 28 day post-vaccination period [Time Frame: 28 days after each vaccination]

Measurement of anti-measles antibodies [Time Frame: Baseline until study day 56]

Solicited local and systemic adverse events [Time Frame: Randomization until study day 56]

Secondary ID(s)

2015-004037-26

MV-CHIK-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors