Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization. 120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of 20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a blinded, randomized manner in the three study arms. A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from CHIKV viremia. Study participants will be followed up until 13 months after initial vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate
Optimal Research, LLC
Huntsville, Alabama, United States
Optimal Research, LLC
Peoria, Illinois, United States
Frequency of solicited injection site reactions
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.
Time frame: up to Day 14 after single vaccination
Severity of solicited injection site reactions
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling. They will be rated according to the Severity Grading Scale of Injection Site Reactions (FDA Guidance on Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007)
Time frame: up to Day 14 after single vaccination
Frequency of solicited systemic reactions
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner
Time frame: up to Day 14 after single vaccination
Severity of solicited systemic reactions
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner. They will be rated according to the FDA Guidance on Toxicity Grading Scales
Time frame: up to Day 14 after single vaccination
Frequency of any adverse event (AE)
Time frame: until Day 14, Day 28 and throughout the study period
Severity of any adverse event (AE)
The investigator will assess the severity of AEs using his/her clinical expertise and judgment based on the most appropriate description (mild, moderate, severe) as per study protocol
Time frame: until Day 14, Day 28 and throughout the study period
Frequency of solicited injection site reactions
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.
Time frame: until Day 14, Day 28 and throughout the study period
Severity of solicited injection site reactions
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling. They will be rated according to the Severity Grading Scale of Injection Site Reactions (FDA Guidance on Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007)
Time frame: until Day 14, Day 28 and throughout the study period
Frequency of solicited systemic reactions
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner
Time frame: until Day 14, Day 28 and throughout the study period
Severity of solicited systemic reactions
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner. They will be rated according to the FDA Guidance on Toxicity Grading Scales
Time frame: until Day 14, Day 28 and throughout the study period
Assessment of viremia after each vaccination
Assessment of CHIKV viremia will be done by RT (real-time)-qPCR (quantitative polymerase chain reaction) in blood and urine
Time frame: on Days 3, 7, 14 and beyond Day 14 after re-vaccination
Immune response as measured by CHIKV-specific neutralizing antibody titer as determined by micro-neutralization (μNT) assay.
Time frame: Day 28, Day 84, Month 6, Month 12, and 28 days after re-vaccination
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