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Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03101111
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
Themis Bioscience GmbH

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE August 9, 2017
Actual Primary Completion Date April 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
Incidence of AEs and abnormal lab values, vital signs, and PE findings [ Time Frame: Throughout the whole study period (until day 392 after first dose) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
Safety [ Time Frame: Throughout the whole study period (until day 392 after first dose) ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
Immunogenicity [ Time Frame: Days 0, 28, 56, 168, 290, and 392 ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 29, 2017)
Viremia [ Time Frame: Days 0, 3, 28, 31, and 56 ]
Measles virus genome equivalents per milliliter of serum.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area
Official Title  ICMJE Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in a Previously Epidemic Area
Brief Summary

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.

Detailed Description

The clinical study to be conducted under this IND will assess the safety of MV-CHIK in a previously epidemic area (Puerto Rico).

A total of 100 healthy volunteers, 50 of whom are seropositive to Chikungunya at baseline and 50 of whom are seronegative, will be randomized in a 4:1 ratio to receive either MV-CHIK or the commercially available MMR vaccine in a double blinded fashion. Memory aids, to be completed by the volunteer at home, and the investigator at scheduled follow-up visits, will solicit symptoms of injection site reactions, fever, headache, malaise, joint and muscle pain. Acute phase reactants (C-reactive protein and ferritin) will be checked routinely throughout the study and at the discretion of the investigator in order to help determine if symptoms, particularly those referred to the joints, have an immunological basis.

This study will also evaluate the immune response in Chikungunya-exposed versus unexposed individuals by comparing neutralizing antibody titers at specific time points. Measles viremia will also be measured and compared between MV-CHIK and MMR recipients, and at three days after the second versus after the first dose. The relationship between measles viremia and the immune response to MV-CHIK will be explored.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, comparator controled, randomized, double-blinded, interventional, safety study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

All subjects will receive two intramuscular injections on day 0 and 28 and one subcutaneous injection on day 0.

Subjects randomized to verum will receive MV-CHIK intramuscularely on days 0 and 28 and placebo subcutaneously in the contralateral arm on day 0.

Subjects randomized to the comparator will receive MMR-vaccine subcutaneously on day 0 and placebo (dummy injection) intramuscularely on days 0 and 28 in the contralateral arm.

Primary Purpose: Prevention
Condition  ICMJE Chikungunya
Intervention  ICMJE
  • Biological: MV-CHIK
    Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose
    Other Names:
    • MV-CHIK vaccine
    • MV-CHIK/DP
  • 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
Study Arms  ICMJE
  • Experimental: 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.

    Intervention: Biological: MV-CHIK
  • Active Comparator: 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.

    Intervention: Biological: MMR-vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2019)
34
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2017)
100
Actual Study Completion Date  ICMJE April 2, 2019
Actual Primary Completion Date April 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03101111
Other Study ID Numbers  ICMJE MV-CHIK-204
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Themis Bioscience GmbH
Study Sponsor  ICMJE Themis Bioscience GmbH
Collaborators  ICMJE Walter Reed Army Institute of Research (WRAIR)
Investigators  ICMJE
Principal Investigator: Clemente Diaz, MD University of Puerto Rico
PRS Account Themis Bioscience GmbH
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP