NCT03101111

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

Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in a Previously Epidemic Area

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Themis Bioscience GmbH · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chikungunya

Interventions

Type	Name	Description
BIOLOGICAL	MV-CHIK	Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose
BIOLOGICAL	MMR-vaccine	Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose

Timeline

• Start date: 2017-08-09
• Primary completion: 2019-04-02
• Completion: 2019-04-02
• First posted: 2017-04-04
• Last updated: 2021-07-19
• Results posted: 2021-07-19

Locations

1 site across 1 country: Puerto Rico

Regulatory

• FDA-regulated drug study