Chikungunya Vaccine Study in Previously Exposed Adults

• ClinicalTrials.gov Identifier: NCT03807843
• Recruitment Status: Recruiting
• First Posted: January 17, 2019
• Last Update Posted: July 26, 2019
• Sponsor: Themis Bioscience GmbH
• Collaborator: Walter Reed Army Institute of Research (WRAIR)
• Information provided by (Responsible Party): Themis Bioscience GmbH

Study Description

Brief Summary:

Safety and immunogenicity of an investigational chikungunya vaccine will be tested in subjects with history of chikungunya infection. Initially 21 to 50 year old subjects will be enrolled; after favorable review of safety data, subjects aged 51 to 65 will be enrolled.

Condition or disease	Intervention/treatment	Phase
Chikungunya Virus Infection	Biological: MV-CHIK; Other: Placebo	Phase 2

Detailed Description:

This will be a prospective randomized double-blind interventional clinical study. This study proposes to evaluate the safety and immunogenicity of an investigational live recombinant measles-vectored chikungunya vaccine (MV-CHIK) 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 MV-CHIK or saline placebo in a 1:1 ratio. This study will be conducted in two Steps, first in up to 30 individuals ages 21 to 50. Then, pending a favorable review of the available vaccine safety data, in up to 30 individuals ages 51 to 65.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, placebo controled, randomized, double-blinded, interventional, safety study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Study medication is available as liquid frozen vaccine product or saline for injection (placebo).

The actual study injections will be prepared by an unblinded team member (e.g. pharmacy personnel) and will be forwarded to the investigator (injector) in a blinded fashion (injection ready syringes containing either verum or placebo). The injector, study subjects, or other site personnel are not informed about the study treatment until unblinding may occur.

• Primary Purpose: Prevention
• Official Title: Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in Previously Exposed Adults
• Actual Study Start Date: July 16, 2019
• Estimated Primary Completion Date: March 4, 2021
• Estimated Study Completion Date: March 4, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Arm; Subjects randomized to the treatment arm will receive two vaccinations with MV-CHIK, a recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins. The vaccinations will be provided on days 0 and 28 after enrollment.	Biological: MV-CHIK; Liquid frozen, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose.; Other Names: MV-CHIK vaccine; MV-CHIK/DP (drug product)
Placebo Comparator: Placebo Arm; Subjects randomized to the placebo arm will receive two injections of sterile physiological saline. The injections will be provided on days 0 and 28 after enrollment.	Other: Placebo; Sterile physiological saline for injection

Outcome Measures

Primary Outcome Measures :

1. Frequency of Adverse Events [ Time Frame: 28 weeks ]
   Incidence of solicited and unsolicited adverse events from enrollment until end of study.

Secondary Outcome Measures :

1. Chikungunya Antibody Titer [ Time Frame: 28 weeks ]
   Geometric mean titer (GMT) of neutralizing antibodies to chikungunya evaluated on days 0, 28, 56, and at the end of the study.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Previous infection with chikungunya as verified by a serum immunoassay.

• Age appropriate for the Step being conducted:

  1. ≥21 to ≤50 years on the day of enrollment for Step 1.
  2. ≥51 to ≤65 years on the day of enrollment for Step 2.
• 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].

Exclusion Criteria:

• 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.
• History of an acute allergic or anaphylactic reaction to any vaccine.
• History of an immunosuppressive disorder (such as 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 subject 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 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 subject 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 subject 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).

Contacts and Locations

Contacts

Contact: Raimund M. Vielnascher, MSc; +43 676 84 34 96 ext 421; raimund.vielnascher@themisbio.com

Contact: Souyet Chang-Rodriguez, PhD; +43 676 84 34 96 ext 763; souyet.chang-rodriguez@themisbio.com

Locations

Puerto Rico

San Juan Hospital, Research Unit; Recruiting

San Juan, Puerto Rico, 00935

Contact: Nicolas Rosario-Matos, MD, MSc +1 787 764 ext 3083 nrosario@sanjuanciudadpatria.com

Contact: Lizbet Fabregas-Troche, MSc +1 787 764 ext 3083 lfabregas@sanjuanciudadpatria.com

Sponsors and Collaborators

Themis Bioscience GmbH

Walter Reed Army Institute of Research (WRAIR)

More Information

• Responsible Party: Themis Bioscience GmbH
• ClinicalTrials.gov Identifier: NCT03807843 History of Changes
• Other Study ID Numbers: MV-CHIK-206
• First Posted: January 17, 2019
• Last Update Posted: July 26, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chikungunya Fever; Virus Diseases; Alphavirus Infections; Togaviridae Infections; RNA Virus Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs