Clinical Trial: Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Themis Bioscience GmbH

Current Primary Outcome: 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: 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.


Current Secondary Outcome: 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: Same as current

Information By: Themis Bioscience GmbH

Dates:
Date Received: March 29, 2017
Date Started: May 24, 2017
Date Completion: March 28, 2019
Last Updated: April 5, 2017
Last Verified: April 2017