Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)

Themis Bioscience

Status and phase: Completed; Phase 2

Conditions: Chikungunya Virus Infection

Treatments: Other: Placebo; Biological: MV-CHIK liquid frozen formulation, high dose; Biological: MV-CHIK lyophilised formulation, low dose; Biological: MV-CHIK SPS® formulation, low dose; Biological: MV-CHIK liquid frozen formulation, low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03635086

2018-000211-25 (EudraCT Number)

V184-005

MV-CHIK-205 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is able 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
• Has a negative serum pregnancy test at screening (for female participants)
• Has a willingness not to become pregnant or to father a child during the entire study period by practicing reliable methods of contraception
• Has availability during the duration of the trial

Exclusion criteria

• Has participated in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period
• Has a history of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
• Has a history of drug addiction including alcohol dependence within the last 2 years
• Has an inability or unwillingness to avoid intake of more than around 20 grams alcohol per day during 48 hours after each vaccination (equals roughly 0.5 liter beer or 0.25 liter of wine)
• Has had a vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until end of treatment period
• Has had a prior receipt of any Chikungunya vaccine
• Has a history of moderate or severe arthritis or arthralgia within the past 3 months prior to screening
• Has had a recent infection within 1 week prior to screening
• Has made 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
• Has clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, 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
• Has a 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
• Has behavioral, 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
• Has a 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
• Has a history of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the participant.
• 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 participants.
• 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
• Has 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
• Has pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
• Has unreliable contraception methods
• Is a person in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 5 patient groups

Group A: Two MV-CHIK lyophilized low dose

Experimental group

Description:

Participants received two vaccinations with MV-CHIK lyophilized formulation, low dose, on day 0 and day 28.

Treatment:

Biological: MV-CHIK lyophilised formulation, low dose

Group B: Two MV-CHIK liquid frozen low dose

Experimental group

Description:

Participants received two vaccinations with MV-CHIK liquid frozen low dose formulation on day 0 and day 28.

Treatment:

Biological: MV-CHIK liquid frozen formulation, low dose

Group C: Two MV-CHIK liquid low dose stabilizing and protecting solution (SPS®)

Experimental group

Description:

Participants received two vaccinations with MV-CHIK liquid low dose SPS® formulation on day 0 and day 28.

Treatment:

Biological: MV-CHIK SPS® formulation, low dose

Group D: Two MV-CHIK liquid frozen high dose

Experimental group

Description:

Participants received two vaccinations with MV-CHIK liquid frozen high dose formulation on day 0 and day 28.

Treatment:

Biological: MV-CHIK liquid frozen formulation, high dose

Group E: One MV-CHIK liquid frozen high dose/placebo

Experimental group

Description:

Participants received one vaccination with MV-CHIK liquid frozen high dose formulation on day 0 and placebo on day 28.

Treatment:

Biological: MV-CHIK liquid frozen formulation, high dose

Other: Placebo