Prevention of Chikungunya Virus Infection
Conditions
Keywords
Chikungunya fever, Alphavirus infections, Togavirus, Viral diseases
Brief summary
This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects. Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.
Interventions
BIOLOGICALmRNA-1944
mRNA encoding Chikungunya antibody
OTHERPlacebo
Saline
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female ≥ 18 and ≤ 50 years of age * Weight of 50 to 100 kg, inclusive * In good general health as determined by medical history, clinical laboratory assessments, ECG results, vital sign measurements, and physical examination findings at screening * Has access to consistent and reliable means of contact and agrees to stay in contact with the study site for the duration of the study
Exclusion criteria
* Any acute or chronic clinically significant disease, as determined by physical examination or laboratory screening tests * Elevated liver function tests or safety laboratory test results * Positive screening test for the presence of anti-CHIKV IgG * Administration of another investigational study involving any investigational product within 60 days or 5 half-lives, whichever is longer * Has received any live attenuated or inactive vaccines within 4 weeks prior to check-in, or plans to receive any vaccine during the study * Known or suspected immune-mediated disease or immunosuppressive condition (including lymphoproliferative disorders) * Any neurologic disorder * History of idiopathic urticaria * Any bleeding disorder that is considered a contraindication to study drug infusion or blood collection * Receipt of immunoglobulins, a monoclonal antibody or any blood products within the preceding 6 months * Any acute illness at the time of enrollment * A positive test result for drugs of abuse * A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies * A history of active cancer (malignancy) in the last 3 years * Donation of ≥ 450 mL blood or blood products within 30 days of study drug infusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities | Through 13 months of study participation |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration (Cmax) after administration of mRNA-1944 | Baseline through 28 days post dose |
| Time of Cmax (tmax) | Baseline through 28 days post dose |
| Terminal elimination half-life (t1/2) | Baseline through 28 days post dose |
| Area under the concentration versus time curve (AUC) | Baseline through 28 days post dose |
| Time to maximum observed effect for (TEmax) for chikungunya virus IgG | Baseline through 13 months |
| Area under the effect curve (AUEC) for chikungunya virus IgG | Baseline through 13 months |
| Maximum observed effect (Emax) for chikungunya virus IgG | Baseline through 13 months |
Countries
United States
Outcome results
None listed