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

NCT03101111 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MV-CHIK-204
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chikungunya

Outcome Measures

Primary Outcomes (1)

• 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.

  Throughout the whole study period (until day 392 after first dose)

Secondary Outcomes (1)

• Immunogenicity

  Days 0, 28, 56, 168, 280, and 392

Study Arms (2)

MV-CHIK and Placebo

EXPERIMENTAL

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

MMR-vaccine and Placebo

ACTIVE COMPARATOR

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

Interventions

MV-CHIK BIOLOGICAL

Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose

Also known as: MV-CHIK vaccine, MV-CHIK/DP

MV-CHIK and Placebo

MMR-vaccine BIOLOGICAL

Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose

Also known as: MPR vaccine

MMR-vaccine and Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Themis Bioscience GmbH: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

University of Puerto Rico - Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

MeSH Terms

Conditions

Chikungunya Fever

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Results Point of Contact

• Title: Christiane Thomasser
• Organization: Themis Bioscience

christiane.thomasser@themisbio.com

01 236 7151

Study Officials

• Clemente Diaz, MD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, comparator controled, randomized, double-blinded, interventional, safety study

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: August 9, 2017
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: July 19, 2021
• Results First Posted: July 19, 2021

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)