Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)
NCT ID: NCT04033068
Last Updated: 2021-12-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2019-08-02
2020-06-10
Brief Summary
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Detailed Description
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After the screening procedures, 48 healthy male and female volunteers aged 18-55 years will be randomly assigned to one of four treatment groups (A, B, C or D). Participants will be assessed for immunogenicity on days 0, 28 and 56 (treatment period), as confirmed by the presence of functional anti-zika-rsp antibodies determined by (PRNT50) and by ELISA, at the same time safety will be also assessed. After the treatment period, participants will be called by phone (day 182) for evaluation of safety follow-up.
The investigator and site personnel assessing AEs, all participants, as well as one of the sponsor's representatives involved in the monitoring and conduct of the study will be blinded to which vaccine was administered. Only the unblinded monitor, site personnel performing randomization, preparation and administration of IMP will be unblinded.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Two MV-ZIKA-RSP vaccinations (high dose)
14 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and day 28
Two MV-ZIKA-RSP vaccinations (high dose)
In this arm of the study, 14 participants will receive:
1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
2. 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)
Two MV-ZIKA-RSP vaccination (low dose)
14 Participants will receive MV-ZIKA-RSP 2,5 x10E4 /dose on day 0 and day 28
Two MV-ZIKA-RSP vaccination (low dose)
In this arm of the study, 14 participants will receive:
1. V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose).
2. 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)
One MV-ZIKA-RSP vaccination (high dose) and one placebo
12 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and placebo on day 28
One MV-ZIKA-RSP vaccination (high dose) and one placebo
In this arm of the study, 12 participants will receive:
1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
2. 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
Two placebo injection
8 Participants will receive placebo on day 0 and placebo on day 28
Two placebo injection
In this arm of the study, 8 participants will receive:
1. V1= day 0; placebo treatment
2. 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
Interventions
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Two MV-ZIKA-RSP vaccinations (high dose)
In this arm of the study, 14 participants will receive:
1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
2. 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)
Two MV-ZIKA-RSP vaccination (low dose)
In this arm of the study, 14 participants will receive:
1. V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose).
2. 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)
One MV-ZIKA-RSP vaccination (high dose) and one placebo
In this arm of the study, 12 participants will receive:
1. V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
2. 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
Two placebo injection
In this arm of the study, 8 participants will receive:
1. V1= day 0; placebo treatment
2. 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
55 Years
ALL
Yes
Sponsors
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Themis Bioscience GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Institute of Specific Prophylaxis and Tropical Medicine
Vienna, , Austria
Countries
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References
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Rossi SL, Comer JE, Wang E, Azar SR, Lawrence WS, Plante JA, Ramsauer K, Schrauf S, Weaver SC. Immunogenicity and Efficacy of a Measles Virus-Vectored Chikungunya Vaccine in Nonhuman Primates. J Infect Dis. 2019 Jul 31;220(5):735-742. doi: 10.1093/infdis/jiz202.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Sponsor Web Page
Other Identifiers
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2019-000840-93
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MV-ZIKA-RSP
Identifier Type: OTHER
Identifier Source: secondary_id
V187-001
Identifier Type: -
Identifier Source: org_study_id