Zika Virus InfectionPhase 1MV-ZIKA-RSPNCT04033068
Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)
A Phase 1 study testing Two MV-ZIKA-RSP vaccinations (high dose) and Two MV-ZIKA-RSP vaccination (low dose) in people with Zika Virus Infection, run by Themis Bioscience GmbH at 1 site in Austria.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Zika Virus Infection
- What is being tested?
- Two MV-ZIKA-RSP vaccinations (high dose) and Two MV-ZIKA-RSP vaccination (low dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 2 Aug 2019to 10 Jun 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent obtained before any trial-related activities
- Healthy men or women aged 18 to 55 years on the day of consenting
- 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
- All female participants must have a negative urine pregnancy serum pregnancy test at screening
- 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
- Availability during the duration of the trial
- Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant
- Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)
Who cannot join
- 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)
- History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
- Strong anamnestic evidence for or confirmed the history of or current infection with Zika- or Dengue-virus
- History of drug addiction including alcohol dependence within the last 2 years
- 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)
- 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)
Show all 21Show fewer
- Prior receipt of any Zika or Chikungunya vaccine
- History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit
- Recent infection within 1 week prior to Screening Visit (possibility of deferral)
- 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)
- 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
- 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
- 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
- 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
- History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer
- Abnormal laboratory values which, at the discretion of the investigator should lead to the exclusion of the subject
- 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)
- 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)
- Pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
- Unreliable contraception methods (for details please refer to protocol section 8.11.4)
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Institute of Specific Prophylaxis and Tropical Medicine
Vienna, 1090
About this study
Official title: Observer Blinded, Randomized Trial to Evaluate Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP
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
Read the detailed description
This is an observer-blinded, block-randomized, dose-finding, phase I trial, comparing different dose levels of MV-ZIKA-RSP to evaluate the safety, tolerability, and immunogenicity, of this novel ZIKA-RSP vaccine. Placebo (physiological saline solution) will be applied to blind the different treatment schedules.
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
- Zika Virus Infection
- Being tested
- 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
- Keywords
- Zika virus, mosquito-borne pathogen, Zika fever
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two MV-ZIKA-RSP vaccinations (high dose)Biological
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)
Two MV-ZIKA-RSP vaccination (low dose)Biological
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)
One MV-ZIKA-RSP vaccination (high dose) and one placeboBiological
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
Two placebo injectionOther
Also called Placebo arm
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
| Study group | Role | What they receive |
|---|---|---|
| Two MV-ZIKA-RSP vaccinations (high dose) | Experimental | 14 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and day 28 Receives: Biological: Two MV-ZIKA-RSP vaccinations (high dose) |
| Two MV-ZIKA-RSP vaccination (low dose) | Experimental | 14 Participants will receive MV-ZIKA-RSP 2,5 x10E4 /dose on day 0 and day 28 Receives: Biological: Two MV-ZIKA-RSP vaccination (low dose) |
| One MV-ZIKA-RSP vaccination (high dose) and one placebo | Experimental | 12 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and placebo on day 28 Receives: Biological: One MV-ZIKA-RSP vaccination (high dose) and one placebo |
| Two placebo injection | Placebo comparator | 8 Participants will receive placebo on day 0 and placebo on day 28 Receives: Other: Two placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56
An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. As specified by the protocol, the percentage of participants who experience an AE up to study Day 56 was presented.
Measured: Up to Day 56
Secondary outcomes (18)
Percentage of Participants Who Experienced a Solicited AE up to Day 182
An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Solicited AEs include local solicited AEs (e.g. injection site pain, tenderness, erythema/redness, swelling, itching and induration) and systemic solicited AEs (e.g. nausea, vomiting, arthralgia, headache, fatigue, myalgia, fever, pain in limb, rash and flu-like symptoms). Solicited AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experience a solicited AE up to study Day 182 was presented.
Measured: Up to Day 182
Percentage of Participants Who Experienced an Unsolicited AE up to Day 182
An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. Unsolicited or spontaneous AEs were recorded in a diary by the participant and verified by the investigator. As specified by the protocol, the percentage of participants who experienced an unsolicited AE up to study Day 182 was presented.
Measured: Up to Day 182
Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect or is another important medical event deemed as much by medical or scientific judgement. As specified by the protocol, the percentage of participants who experience an SAE up to study Day 182 was presented.
Measured: Up to Day 182
Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56
The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of a VNT, an immunoassay that detects and quantifies antibodies in serum samples that can neutralize infectious Zika virions. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by the VNT on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the lower limit of quantification (LLOQ) were set to the half of the true LLOQ value and values above the upper limit of quantification (ULOQ) were set to the true ULOQ value for calculations.
Measured: Day 0, Day 28 and Day 56
GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56
The induction of functional anti-ZIKA-RSP antibodies by V187 was investigated in sera from participants by means of Immunoglobulin G (IgG) ELISA, an immunoassay that quantifies anti-ZIKA-RSP IgG. As specified by the protocol, the GMT of anti-ZIKA-RSP antibodies by ELISA on Day 0 (first dose), Day 28 (second dose) and Day 56 (follow-up assessment) was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.
Measured: Day 0, Day 28 and Day 56
T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56
Immune response mediated by functional T-cells was investigated using an IFNγ enzyme-linked immune adsorbent spot (ELISpot) assay. This is an immunoassay that quantifies IFNγ producing cells by assessing the number of SFCs per 10^6 PBMCs stimulated with a peptide pool containing the viral protein prM*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IFNγ SFCs per 10^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.
Measured: Day 56
T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56
Immune response mediated by functional T-cells was investigated using an IL-2 ELISpot assay. This is an immunoassay that quantifies IL-2 producing cells by assessing the number of SFCs per 10^6 PBMCs stimulated with a peptide pool containing the viral protein prM*; a precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual cytokine-secreting cell. As specified by the protocol, median of the number of IL-2 SFCs per 10^6 PBMCs on Day 56 was presented. Values below the LLOQ were set to the half of the true LLOQ value and values above the ULOQ were set to the true ULOQ value for calculations.
Measured: Day 56
Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56
Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56
Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of erythrocytes on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56
Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hematocrit on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56
Hematological parameters were investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of hemoglobin on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56
Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56
Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of sodium, calcium and potassium on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56
Clinical chemistry parameters were investigated in sera from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the concentration of bilirubin and creatinine on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameter (Urinalysis): pH on Days 28 and 56
Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the pH on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56
Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. As specified by the protocol, the specific gravity on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56
Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein levels were defined as negative by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants negative for bilirubin, erythrocytes, ketones, leukocytes, nitrite and protein on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56
Urinalysis parameters were investigated in urine samples from participants by means of clinical laboratory assays and evaluated by the investigator. Glucose and urobilinogen were defined as normal by the local laboratory and reported at the study site. As specified by the protocol, the percentage of participants normal for glucose and urobilinogen on Day 28 (second dose) and Day 56 (follow-up assessment) was presented.
Measured: Day 28 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start2 Aug 2019
- Primary completion30 Jan 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zika Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Themis Bioscience GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033068
- Sponsor's protocol ID
- V187-001
- Other IDs
- 2019-000840-93, MV-ZIKA-RSP, 2019
- Acronym
- MV-ZIKA-RSP
- Status last verified
- Oct 2021
- First submitted
- 8 Jul 2019
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 31053842
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observer Blinded, Randomized Trial to Evaluate Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP
- ClinicalTrials.gov ID
- NCT04033068
- Acronym / sponsor ID
- MV-ZIKA-RSP / V187-001
- Conditions
- Zika Virus Infection
- Keywords
- Zika virus, mosquito-borne pathogen, Zika fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Themis Bioscience GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Posted 6 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an observer-blinded, block-randomized, dose-finding, phase I trial, comparing different dose levels of MV-ZIKA-RSP to evaluate the safety, tolerability, and immunogenicity, of this novel ZIKA-RSP vaccine. Placebo (physiological saline solution) will be applied to blind the different treatment schedules.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Two MV-ZIKA-RSP vaccinations (high dose) | Experimental | Biological: 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 vaccination (low dose) | Experimental | Biological: Two MV-ZIKA-RSP vaccination (low dose)14 Participants will receive MV-ZIKA-RSP 2,5 x10E4 /dose on day 0 and day 28 |
| One MV-ZIKA-RSP vaccination (high dose) and one placebo | Experimental | Biological: One MV-ZIKA-RSP vaccination (high dose) and one placebo12 Participants will receive MV-ZIKA-RSP 1 x10E5/dose on day 0 and placebo on day 28 |
| Two placebo injection | Placebo comparator | Other: Two placebo injection8 Participants will receive placebo on day 0 and placebo on day 28 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent obtained before any trial-related activities
- Healthy men or women aged 18 to 55 years on the day of consenting
- 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
- All female participants must have a negative urine pregnancy serum pregnancy test at screening
- 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
Key exclusion criteria (21 listed)
- 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)
- History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
- Strong anamnestic evidence for or confirmed the history of or current infection with Zika- or Dengue-virus
- History of drug addiction including alcohol dependence within the last 2 years
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Biological | Two MV-ZIKA-RSP vaccinations (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) | Biological | Two MV-ZIKA-RSP vaccination (low dose) |
| One MV-ZIKA-RSP vaccination (high dose) and one placeboIn 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 | Biological | One MV-ZIKA-RSP vaccination (high dose) and one placebo |
| Two placebo injectionAlso: Placebo armIn 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 | Two placebo injection |
Primary outcome
Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56
Time frame: Up to Day 56
An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. As specified by the protocol, the percentage of participants who experience an AE up to study Day 56 was presented.
18 secondary outcomes
Percentage of Participants Who Experienced a Solicited AE up to Day 182
Time frame: Up to Day 182
Percentage of Participants Who Experienced an Unsolicited AE up to Day 182
Time frame: Up to Day 182
Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182
Time frame: Up to Day 182
Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56
Time frame: Day 0, Day 28 and Day 56
GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56
Time frame: Day 0, Day 28 and Day 56
T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56
Time frame: Day 56
T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56
Time frame: Day 56
Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameter (Urinalysis): pH on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56
Time frame: Day 28 and Day 56
Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56
Time frame: Day 28 and Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31053842Rossi 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.
- Sponsor Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Two MV-ZIKA-RSP vaccinations (high dose) and Two MV-ZIKA-RSP vaccination (low dose) in people with Zika Virus Infection, run by Themis Bioscience GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56 (time frame: Up to Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.