Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)
Condition: Zika Virus Infection
MeSH terms: Zika Virus Infection
Intervention: Two MV-ZIKA-RSP vaccinations (high dose); Two MV-ZIKA-RSP vaccination (low dose); One MV-ZIKA-RSP vaccination (high dose) and one placebo; Two placebo injection
Intervention description: In this arm of the study, 14 participants will receive:
V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
V2= day 28; dose vaccination with MV-ZIKA-RSP (high dose).
Description:
Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (high dose); In this arm of the study, 14 participants will receive:
V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose).
V2= day 28; dose vaccination with MV-ZIKA-RSP (low dose).
Description:
Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (low dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (low dose); In this arm of the study, 12 participants will receive:
V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
V2= day 28; treatment with placebo
Description:
Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second treatment with placebo; In this arm of the study, 8 participants will receive:
V1= day 0; placebo treatment
V2= day 28; placebo treatment
Description:
Visit 1: Participants will receive their first treatment with placebo Visit 2: Participants will receive their second treatment with placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Zika virus; mosquito-borne pathogen; Zika fever

Summary:

      This study is designed to investigate, at first, safety and tolerability of a novel liquid
      vaccine formulation named MV-ZIKA-RSP, in healthy adults aged 18 to 55 years
    

Eligibility 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 participants must have a negative urine pregnancy serum pregnancy test at
             screening

          5. Willingness not to become pregnant or to father a child during the entire study period
             by practising reliable methods of contraception as specified in protocol section
             8.11.4

          6. Availability during the duration of the trial

          7. Normal findings in medical history and physical examination or the investigator
             considers all abnormalities to be clinically irrelevant

          8. 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 (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 (day 56)

          2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection or
             current hepatitis B/C infection

          3. Strong anamnestic evidence for or confirmed the history of or current infection with
             Zika- or Dengue-virus

          4. History of drug addiction including alcohol dependence within the last 2 years

          5. 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)

          6. Vaccination within 4 weeks prior to first vaccination or planning to receive any
             non-study vaccine until the end of the treatment period (day 56)

          7. Prior receipt of any Zika or Chikungunya vaccine

          8. History of moderate or severe arthritis or arthralgia within the past 3 months prior
             to Screening Visit

          9. Recent infection within 1 week prior to Screening Visit (possibility of deferral)

         10. Blood donations including plasma donations, 90 days prior to Screening Visit and
             anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until
             the end of the treatment period (day 56)

         11. 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

         12. 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

         13. 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

         14. 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

         15. History of anaphylaxis to drugs or other allergic reactions, which the investigator
             considers compromising the safety of the volunteer

         16. Abnormal laboratory values which, at the discretion of the investigator should lead to
             the exclusion of the subject

         17. 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. (Prior
             to taking any medication within 72 h before study vaccination, the subject should
             consult the investigator)

         18. Use of immunosuppressive drugs like corticosteroids (excluding topical preparations)
             within 30 days prior to first IMP administration, or anticipated use until completion
             of the end of treatment visit 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)

         19. Pregnancy (positive pregnancy test at screening or during the treatment period) or
             lactation at screening, or planning to become pregnant during the treatment period

         20. Unreliable contraception methods (for details please refer to protocol section 8.11.4)

         21. Persons 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