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

Primary Purpose

Chikungunya

Status
Completed
Phase
Phase 2
Locations
Puerto Rico
Study Type
Interventional
Intervention
MV-CHIK
MMR-vaccine
Sponsored by
Themis Bioscience GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chikungunya

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Puerto Rico - Medical Sciences Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MV-CHIK and Placebo

MMR-vaccine and Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings
Number of solicited and unsolicited adverse events and number 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.

Secondary Outcome Measures

Immunogenicity
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.

Full Information

First Posted
March 29, 2017
Last Updated
June 28, 2021
Sponsor
Themis Bioscience GmbH
Collaborators
Walter Reed Army Institute of Research (WRAIR)
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1. Study Identification

Unique Protocol Identification Number
NCT03101111
Brief Title
Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area
Official Title
Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in a Previously Epidemic Area
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Themis Bioscience GmbH
Collaborators
Walter Reed Army Institute of Research (WRAIR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, comparator controled, randomized, double-blinded, interventional, safety study
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MV-CHIK and Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
MMR-vaccine and Placebo
Arm Type
Active Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
MV-CHIK
Other Intervention Name(s)
MV-CHIK vaccine, MV-CHIK/DP
Intervention Description
Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose
Intervention Type
Biological
Intervention Name(s)
MMR-vaccine
Other Intervention Name(s)
MPR vaccine
Intervention Description
Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose
Primary Outcome Measure Information:
Title
Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings
Description
Number of solicited and unsolicited adverse events and number 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)
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged ≥21 to ≤50 years on the day of enrollment. 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 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. Medical history and physical examination findings are considered normal or not clinically significant in the opinion of the Investigator. Laboratory values are considered normal or not clinically significant in the opinion of the Investigator. History of previous measles vaccination, either in childhood or as an adult if more than three months before participation in this study. Exclusion Criteria: Taking medication or other treatment for unresolved symptoms attributed to a previous chikungunya virus infection. Prior receipt of any chikungunya or other alphavirus vaccine. Recent infection, including suspected chikungunya (within 1 week prior to Screening Visit). History of an allergic or anaphylactic reaction to any vaccine. 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. 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. 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). Measles vaccination or booster within the last 3 months or planned during the clinical study. 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 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. 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. 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 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemente Diaz, MD
Organizational Affiliation
University of Puerto Rico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Puerto Rico - Medical Sciences Campus
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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