Chikungunya Virus InfectionPhase 2NCT03807843
Chikungunya Vaccine (V184) Study in Previously Exposed Adults (V184-006)
A Phase 2 study testing V184 in people with Chikungunya Virus Infection, run by Themis Bioscience GmbH at 1 site in Puerto Rico.
Trial summary
Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in participants with history of chikungunya infection. Initially 21 to 50 year old participants will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be enrolled. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Virus Infection
- What is being tested?
- V184
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 16 Jul 2019to 13 May 2021
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previous infection with chikungunya as verified by a serum immunoassay.
- Able to provide informed consent.
- Available and accessible for the duration of the trial.
- Able and willing to comply with all requirements of the study.
- For women of childbearing potential, willing to practice adequate contraception for the duration of the study.
- Medical history and physical examination findings are considered normal or not clinically significant in the opinion of the Investigator, which includes resolution of any arthralgias that may have occurred during prior chikungunya infection, as well as the absence of synovitis.
- Laboratory values are considered normal or not clinically significant in the opinion of the Investigator. If laboratory screening tests are out of the normal reference range and of potential clinical significance, the test(s) may be repeated up to 2 times (a total of 3 per screening evaluation) at the discretion of the Investigator, and the repeat values and their potential clinical significance will be used to determine eligibility.
- History of immunity to measles. For persons born after 1957, this will be established by a history of compliance with vaccination policies that included measles vaccination or known vaccination as an adult at least one month before they are randomized. Volunteers born before 1957 will be presumed to have immunity to measles based on natural exposure in accordance with US Centers for Disease Control and Prevention (CDC) guidelines [McLean 2013].
Who cannot join
- Taking medication or other treatment for unresolved symptoms attributed to a previous chikungunya virus infection.
- Prior receipt of any investigational chikungunya or other alphavirus vaccine. To date, no alphavirus vaccines have been commercially available in the United States.
- Recent infection:
- self-limited upper respiratory infections until afebrile without medication for >1 week;
- chikungunya unless/until asymptomatic (other than mild subjective symptoms not requiring treatment) for >3 months;
- non-recurrent upper respiratory or urinary tract infections successfully treated with antibiotics, until asymptomatic for 1 month after full antibiotic course has been completed.
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- History of an acute allergic or anaphylactic reaction to any vaccine.
- History of an immunosuppressive disorder (such as human immunodeficiency virus [HIV] infection, Common Variable Immune Deficiency), chronic infection (such as chronic hepatitis B or C), autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune thyroid disease), or any medical condition that, in the opinion of the Investigator, could lead to an atypical immune response to the vaccine.
- History of moderate or severe non-traumatic arthritis or arthralgia within 3 months of the Screening Visit.
- Recent (within 30 days), current or anticipated use of any immunosuppressive or immune modifying medication including corticosteroids (excluding nasal, ophthalmic, and other topical preparations).
- Other vaccination or planned vaccination within 4 weeks of either study dose (seasonal influenza vaccine excepted).
- Receipt or planned receipt of blood products including immunoglobulins within 120 days of the Screening Visit.
- Pregnant or lactating or planning pregnancy during the trial.
- Known alcohol or other substance abuse that in the opinion of the Investigator affects the ability or willingness of the participant to understand and comply with the study protocol.
- Participation in another clinical study within the past 30 days in which the participant was exposed to an investigational product (pharmaceutical product or placebo or device) or planned participation in another interventional clinical study while participating in this study.
- Relevant history of any medical condition that, in the opinion of the Investigator, may interfere with the safety of the participant or aims of the study.
- History of neoplastic disease (excluding successfully treated non-melanoma skin cancer or cervical intraepithelial neoplasia) within the past 5 years or a history of any hematological malignancy.
- Behavioral or psychiatric disease or cognitive impairment that in the opinion of the Investigator affects the ability or willingness of the participant to understand and comply with the study protocol.
- Non-consent to storage of blood specimens for future research.
- Persons in direct relationship with the Sponsor or its contracted service providers, the contract research organisation (CRO) or its subcontractors, the Investigator, or study site staff. Direct relationship includes first degree relatives or dependents (children, spouse/partner, siblings or parents), as well as employees (site or Sponsor).
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
San Juan Hospital, Research Unit
San Juan, Puert Rico, 00935
About this study
Official title: Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in Previously Exposed Adults
Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in participants with history of chikungunya infection. Initially 21 to 50 year old participants will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be enrolled.
Read the detailed description
This will be a randomized double-blind interventional clinical study. This study proposes to evaluate the safety and immunogenicity of the investigational V184 live recombinant measles-vectored chikungunya vaccine delivered in 2 vaccinations, 28 days apart compared with saline placebo. After providing informed consent, individuals will be screened for eligibility including verification of previous exposure to chikungunya virus. They will then be randomized in a double-blind fashion to receive either V184 or saline placebo in a 1:1 ratio.
- Conditions
- Chikungunya Virus Infection
- Being tested
- V184, Placebo
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V184Biological
Also called MV-CHIK, MV-CHIK vaccine, MV-CHIK/DP (drug product)
Recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. Liquid frozen, life attenuated, measles vectored V184 vaccine administered via IM injection at 5 × 10^5 TCID50 (+/- 0.5 log) per dose.
PlaceboOther
Sterile physiological saline for IM injection
| Study group | Role | What they receive |
|---|---|---|
| V184 | Experimental | Participants will receive 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28. Receives: Biological: V184 |
| Placebo | Placebo comparator | Participants will receive 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. The number of participants with solicited AEs following Vaccination 1 (Day 0) or Vaccination 2 (Day 28) were reported for each group.
Measured: Up to 7 days after vaccination (up to Day 35)
Number of Participants With Unsolicited AEs
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. The number of participants with unsolicited AEs were reported for each group.
Measured: Up to Day 196
Number of Participants With Solicited and Unsolicited AEs of Grade 2 or Higher According to the 2007 Toxicity Grading Scale for Healthy Adult Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007)
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. AEs were graded by the investigator for severity as per the FDA Toxicity Grading Scale for Healthy Adults Enrolled in Vaccine Clinical Trials (2007), where Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life threatening. A higher grade indicates increased severity of AE. The number of participants with solicited and unsolicited AEs of grade 2 (moderate) or higher were reported for each group.
Measured: Up to Day 196
Secondary outcomes (1)
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time
Serum samples were collected and the titers of serum neutralization antibodies were assessed. GMTs were calculated using a mixed effects model with treatment (V184 versus placebo), visit and age group, and treatment visit interaction as fixed factors and participant as a random effect. GMFR was defined as the geometric mean of the ratio of concentration at specified timepoints after vaccination divided by concentration at baseline (Day 0).
Measured: Days 0, 28, 56, and 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start16 Jul 2019
- Primary completion13 May 2021
- Study completion13 May 2021
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.
- Other trials for Chikungunya 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled, randomized, double-blinded, interventional, safety study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Themis Bioscience GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807843
- Sponsor's protocol ID
- V184-006
- Other IDs
- MV-CHIK-206
- Status last verified
- Sep 2022
- First submitted
- 15 Jan 2019
- Last updated
- 8 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in Previously Exposed Adults
- ClinicalTrials.gov ID
- NCT03807843
- Acronym / sponsor ID
- V184-006
- Conditions
- Chikungunya Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Themis Bioscience GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Posted 16 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in participants with history of chikungunya infection. Initially 21 to 50 year old participants will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be enrolled.
Detailed description
This will be a randomized double-blind interventional clinical study. This study proposes to evaluate the safety and immunogenicity of the investigational V184 live recombinant measles-vectored chikungunya vaccine delivered in 2 vaccinations, 28 days apart compared with saline placebo. After providing informed consent, individuals will be screened for eligibility including verification of previous exposure to chikungunya virus. They will then be randomized in a double-blind fashion to receive either V184 or saline placebo in a 1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled, randomized, double-blinded, interventional, safety study
| Arm | Type | Receives |
|---|---|---|
| V184 | Experimental | Biological: V184Participants will receive 2 vaccinations with V184 administered via intramuscular (IM) injection at 5 × 10^5 Tissue Culture Infectious Dose (TCID50) per dose on Days 0 and 28. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive 2 injections of sterile physiological saline administered via IM injection on Days 0 and 28. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Previous infection with chikungunya as verified by a serum immunoassay.
- Able to provide informed consent.
- Available and accessible for the duration of the trial.
- Able and willing to comply with all requirements of the study.
- For women of childbearing potential, willing to practice adequate contraception for the duration of the study.
Key exclusion criteria (20 listed)
- Taking medication or other treatment for unresolved symptoms attributed to a previous chikungunya virus infection.
- Prior receipt of any investigational chikungunya or other alphavirus vaccine. To date, no alphavirus vaccines have been commercially available in the United States.
- Recent infection:
- History of an acute allergic or anaphylactic reaction to any vaccine.
- History of an immunosuppressive disorder (such as human immunodeficiency virus [HIV] infection, Common Variable Immune Deficiency), chronic infection (such as chronic hepatitis B or C), autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune thyroid disease), or any medical condition that, in the opinion of the Investigator, could lead to an atypical immune response to the vaccine.
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 |
|---|---|---|
| V184Also: MV-CHIK, MV-CHIK vaccine, MV-CHIK/DP (drug product)Recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. Liquid frozen, life attenuated, measles vectored V184 vaccine administered via IM injection at 5 × 10^5 TCID50 (+/- 0.5 log) per dose. | Biological | V184 |
| PlaceboSterile physiological saline for IM injection | Other | Placebo |
Primary outcome
Number of Participants With Solicited Adverse Events (AEs)
Time frame: Up to 7 days after vaccination (up to Day 35)
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. The number of participants with solicited AEs following Vaccination 1 (Day 0) or Vaccination 2 (Day 28) were reported for each group.
Number of Participants With Unsolicited AEs
Time frame: Up to Day 196
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. The number of participants with unsolicited AEs were reported for each group.
Number of Participants With Solicited and Unsolicited AEs of Grade 2 or Higher According to the 2007 Toxicity Grading Scale for Healthy Adult Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007)
Time frame: Up to Day 196
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. AEs were graded by the investigator for severity as per the FDA Toxicity Grading Scale for Healthy Adults Enrolled in Vaccine Clinical Trials (2007), where Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life threatening. A higher grade indicates increased severity of AE. The number of participants with solicited and unsolicited AEs of grade 2 (moderate) or higher were reported for each group.
1 secondary outcome
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time
Time frame: Days 0, 28, 56, and 196
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 2 study testing V184 in people with Chikungunya Virus Infection, run by Themis Bioscience GmbH at 1 site in Puerto Rico.
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 20 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 8 Sep 2022. 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 Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 16 May 2022). 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?
Number of Participants With Solicited Adverse Events (AEs) (time frame: Up to 7 days after vaccination (up to Day 35)). The study lists 3 primary outcomes in all. 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 8 Sep 2022.