Zika VirusPhase 1NCT02996890
Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)
A Phase 1 study testing MV-ZIKA in people with Zika Virus, run by Themis Bioscience GmbH at 2 sites in Austria.
Trial summary
Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects. After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0… 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
- What is being tested?
- MV-ZIKA
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesAustria
- Study dates
- 3 May 2017to 17 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- healthy volunteers aged 18 to 55
- subjects of child bearing potential must perform reliable method of contraception
Who cannot join
- immune deficiency, history of HIV, HBV, HCV
- drug addiction
- vaccination within 4 weeks prior to study or planned vaccination during study
- prior receipt of any Zika vaccine
- recent infection 1 week prior to screening
- relevant medical history interfering with aim of study
Show all 17Show fewer
- neoplastic disease, hematological malignancy
- history of autoimmune disease
- psychological condition that affects ability to participate in the study
- history of severe adverse reactions to vaccine administration
- history of anaphylaxis
- allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator
- use of immunosuppressive drugs within 30 days before screening or planned use during study
- receipt of blood products within 120 days before screening or planned use during study
- pregnancy, unreliable contraception method
- decision of the investigator
- regular blood plasma donor
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University of Vienna, Center for Pathophysiology, Infectiology and Immunology
Vienna, 1090
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, 1090
About this study
Official title: Double Blinded, Randomized, Placebo Controlled, Dose Finding Trial to Evaluate the Optimal Dose of MV-ZIKA, a New Vaccine Against Zika Virus, in Regard to Immunogenicity, Safety, and Tolerability in Healthy Volunteers
Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects.
After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28.
Subjects will return on day 56 for the final visit.
- Conditions
- Zika Virus
- Being tested
- MV-ZIKA, Placebo
- 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.
MV-ZIKABiological
MV-Zika vaccine
PlaceboOther
physiological saline
| Study group | Role | What they receive |
|---|---|---|
| High dose - single shot | Experimental | MV-ZIKA, high dose, one vaccination, day 0 Receives: Biological: MV-ZIKA; Other: Placebo |
| Low dose | Experimental | MV-ZIKA, low dose, two vaccinations, day 0 and day 28 Receives: Biological: MV-ZIKA |
| High dose | Experimental | MV-ZIKA, high dose, two vaccinations, day 0 and day 28 Receives: Biological: MV-ZIKA |
| Placebo | Placebo comparator | Physiological saline, two treatments Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
Functional anti-Zika antibodies as measured by PRNT.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start3 May 2017
- Primary completion4 Jan 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zika VirusStudies 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
- NCT02996890
- Sponsor's protocol ID
- V186-001
- Other IDs
- 2016-004212-34, MV-ZIKA-101, 2016
- Status last verified
- Aug 2022
- First submitted
- 15 Dec 2016
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized, Placebo Controlled, Dose Finding Trial to Evaluate the Optimal Dose of MV-ZIKA, a New Vaccine Against Zika Virus, in Regard to Immunogenicity, Safety, and Tolerability in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02996890
- Acronym / sponsor ID
- V186-001
- Conditions
- Zika Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Themis Bioscience GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 May 2017 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects.
After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28.
Subjects will return on day 56 for the final visit.
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 |
|---|---|---|
| High dose - single shot | Experimental | Biological: MV-ZIKA, Other: PlaceboMV-ZIKA, high dose, one vaccination, day 0 |
| Low dose | Experimental | Biological: MV-ZIKAMV-ZIKA, low dose, two vaccinations, day 0 and day 28 |
| High dose | Experimental | Biological: MV-ZIKAMV-ZIKA, high dose, two vaccinations, day 0 and day 28 |
| Placebo | Placebo comparator | Other: PlaceboPhysiological saline, two treatments |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteers aged 18 to 55
- subjects of child bearing potential must perform reliable method of contraception
Key exclusion criteria (17 listed)
- immune deficiency, history of HIV, HBV, HCV
- drug addiction
- vaccination within 4 weeks prior to study or planned vaccination during study
- prior receipt of any Zika vaccine
- recent infection 1 week prior to screening
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 |
|---|---|---|
| MV-ZIKAMV-Zika vaccine | Biological | High dose, High dose - single shot, Low dose |
| Placebophysiological saline | Other | High dose - single shot, Placebo |
Primary outcome
Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
Time frame: 56 days
Functional anti-Zika antibodies as measured by PRNT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MV-ZIKA in people with Zika Virus, run by Themis Bioscience GmbH at 2 sites 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 2 inclusion and 17 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunogenicity: Functional anti-Zika antibodies as measured by PRNT (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2022.