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Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in a Previously Epidemic Area

Trial Profile

Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in a Previously Epidemic Area

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Nov 2021

At a glance

  • Drugs Chikungunya virus vaccine (Primary) ; Measles mumps and rubella virus vaccine
  • Indications Chikungunya virus infections
  • Focus Adverse reactions
  • Sponsors Themis Bioscience
  • Most Recent Events

    • 29 Jul 2019 Status changed from active, no longer recruiting to completed.
    • 19 Jun 2018 Status changed from recruiting to active, no longer recruiting.
    • 17 Aug 2017 Status changed from not yet recruiting to recruiting.

Trial Overview

Purpose

The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will be assessed. MV-CHIK will be compared to the commercially available MMR vaccine. 80% of the subjects will receive MV-CHIK; 20% will receive MMR vaccine.

Primary Endpoints

Incidence of AEs and abnormal lab values, vital signs, and PE findings

description: Incidence of solicited and unsolicited adverse events and incidence of grade 2 and higher solicited and unsolicited adverse events including clinically significant abnormal safety laboratory results, vital signs, and physical examination findings in previously exposed versus unexposed individuals.
time_frame: Throughout the whole study period (until day 392 after first dose)

Other Endpoints

Immunogenicity

description: Immunogenicity on days 0, 28, 56, 168, 280, and at the end of the study measured as geometric mean titer (GMT) of neutralizing antibodies to chikungunya in previously exposed versus unexposed individuals. time_frame: Days 0, 28, 56, 168, 280, and 392 [1]

Diseases Treated

Indication Qualifiers Patient Segments
Chikungunya virus infections prevention -

Biomarker

NCT Number Biomarker Name Biomarker Function
NCT03101111 C-reactive protein (CRP) Detailed Description
Ferritin Detailed Description
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Subjects

  • Subject Type patients
  • Number

    Planned: 100

    Actual: 34

  • Sex male & female
  • Age Group 21-50 years; adult

Patient Inclusion Criteria

1. Aged ≥21 to ≤50 years on the day of enrollment. 2. Able to provide informed consent. 3. Available and accessible for the duration of the trial. 4. Able and willing to comply with all requirements of the study. 5. For female subjects, willing to practice a reliable form of contraception as specified in the protocol until five months after the second and final vaccination in accordance with recommendations following MMR vaccination. 6. Medical history and physical examination findings are considered normal or not clinically significant in the opinion of the Investigator. 7. Laboratory values are considered normal or not clinically significant in the opinion of the Investigator. 8. History of previous measles vaccination, either in childhood or as an adult if more than three months before participation in this study.

Patient Exclusion Criteria

1. Taking medication or other treatment for unresolved symptoms attributed to a previous chikungunya virus infection. 2. Prior receipt of any chikungunya or other alphavirus vaccine. 3. Recent infection, including suspected chikungunya (within 1 week prior to Screening Visit). 4. History of an allergic or anaphylactic reaction to any vaccine. 5. An allergic reaction other than allergic contact dermatitis to any component of either vaccine (i.e., neomycin, gelatin), or a current egg allergy. Volunteers with a childhood history of egg allergy who are able to tolerate egg in their diet now will not be excluded on this basis. 6. History of an immunosuppressive disorder (such as human immunodeficiency virus [HIV] infection, common variable immunodeficiency), 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. 7. History of moderate or severe non-traumatic arthritis or arthralgia within 3 months of the Screening Visit. 8. Recent (within 30 days), current or anticipated use of any immunosuppressive or immune modifying medication including corticosteroids (excluding nasal, ophthalmic, and other topical preparations). 9. Other vaccination or planned vaccination within 4 weeks of either study dose (seasonal influenza vaccine excepted). 10. Measles vaccination or booster within the last 3 months or planned during the clinical study. 11. Receipt or planned receipt of blood products including immunoglobulins within 120 days of the Screening Visit. 12. Pregnant or lactating or planning pregnancy during the trial. 13. 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. 14. Participation in another clinical study within the past 30 days in which the subject was exposed to an investigational product (pharmaceutical product or placebo or device) or planned concurrent participation in another clinical study during the study period. 15. Relevant history of any medical condition that, in the opinion of the Investigator, may interfere with the safety of the subject (volunteer) or aims of the study. 16. 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. 17. 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. 18. Non-consent to storage of blood specimens for future research. 19. Persons in direct relationship with the Sponsor or its contract service provider, the clinical research organization (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). Employees of the University of Puerto Rico not directly employed by the Clinical & Translational Research Center will not be excluded. 20. Any condition that would, in the opinion of the site Investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Trial Details

Identifiers

Identifier Owner
NCT03101111 ClinicalTrials.gov: US National Institutes of Health
MV-CHIK204 -

Organisations

  • Sponsors Themis Bioscience
  • Affiliations Themis Bioscience

Trial Dates

  • Initiation Dates

    Planned : 01 Aug 2017

    Actual : 09 Aug 2017

  • Primary Completion Dates

    Planned : 28 Mar 2019

    Actual : 02 Apr 2019

  • End Dates

    Planned : 28 Mar 2019

    Actual : 02 Apr 2019

Other Details

  • Design double-blind; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Puerto Rico
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
Chikungunya virus vaccinePrimary Drug Intramuscular Injection
Measles mumps and rubella virus vaccine Subcutaneous Injection

MV-CHIK and Placebo

Subjects will receive two injections on study day 0 and one injection on day 28.
On both days they will receive a 5E+05 (+/- 0.5 log) TCID50 intramuscularly in the deltoid muscle of one arm.
On day 0 they will receive a dummy injection of placebo (physiological saline) subcutaneously in the contralateral arm.
Biological: MV-CHIK (Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose) Other Name: MV-CHIK vaccine, MV-CHIK/DP

MMR-vaccine and Placebo

Subjects will receive two injections on study day 0 and one injection on day 28.
On both days they will receive dummy injections of placebo (physiological saline) in the deltoid muscle of one arm.
On day 0 they will receive MMR-vaccine subcutaneously in the contralateral arm.
Biological: MMR-vaccine (Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose) Other Name: MPR vaccine

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Andrea Pfeiffer, MSc
+43 676 84 34 96 Ext: 420
andrea.pfeiffer@themisbio.com
show details
-
Clemente Diaz, MD
+1 787 381 6246
show details
University of Puerto Rico - Medical Sciences Campus Puerto-Rico
Raimund M. Vielnascher, MSc
+43 676 84 34 96 Ext: 421
raimund.vielnascher@themisbio.com
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Themis Bioscience GmbH
-
-
University of Puerto Rico - Medical Sciences Campus San Juan Puerto-Rico
Walter Reed Army Institute of Research (WRAIR)
-
-

Trial History

Event Date Event Type Comment
20 Jul 2021 Other trial event Last checked against the ClinicalTrials.gov record. Updated 20 Jul 2021
19 Jul 2021 Biomarker Update Biomarkers information updated Updated 05 Nov 2021
29 Jul 2019 Status change - completed Status changed from active, no longer recruiting to completed. Updated 31 Jul 2019
19 Jun 2018 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 28 Jun 2018
17 Aug 2017 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 24 Aug 2017
01 Aug 2017 Other trial event Planned initiation date changed from 24 May 2017 to 1 Aug 2017. Updated 06 Aug 2017
10 Apr 2017 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 19 Feb 2018
10 Apr 2017 New trial record New trial record Updated 10 Apr 2017
05 May 2015 Other trial event According to a Themis Bioscience media release, company plans to initiate Phase II trials for Chikungunya fever vaccine. Updated 19 Feb 2018

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.

    Available from: URL: http://clinicaltrials.gov
  2. Themis Bioscience. Themis Bioscience's Raises up to EUR 10 Million in Series B. Media-Rel 2015;.

    Media Release
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