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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
34
Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose
Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose
University of Puerto Rico - Medical Sciences Campus
San Juan, Puerto Rico
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.
Time frame: Throughout the whole study period (until day 392 after first dose)
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.
Time frame: Days 0, 28, 56, 168, 280, and 392
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