The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels.
The study will enroll five cohorts. Ascending doses of MVX01 will be evaluated in cohorts 1-4, in participants 18-50 years of age. The highest tolerated dose from cohorts 1-4 will be evaluated in cohort 5, in participants 60-75 years of age. Cohort 1 will be open-label. Cohorts 2-5 will enroll two open-label sentinel participants followed by the remainder of the cohort which will be randomized and double-blind. Each participant will be administered two doses of study intervention via intramuscular injection, approximately 1 month apart. Immunogenicity will be evaluated up to approximately 6 months following administration of the second dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
75
Pneumococcal Vaccine Candidate
Placebo
Velocity (Meridian) Clinical Research
Savannah, Georgia, United States
Alliance for Multispecialty Research (AMR)
Knoxville, Tennessee, United States
Incidence of immediate reactogenicity adverse events
Number and percentage of immediate reactogenicity events by severity. Including: * Local expected at injection site: erythema/redness; induration/hardening; pain; pruritus/itching; tenderness. * Systemic expected: fatigue; fever; flu-like symptoms; headache; myalgia/muscle pain; nausea; rash; vomiting.
Time frame: Up to 30 minutes after each dose
Incidence of solicited reactogenicity events
Number and percentage of solicited reactogenicity adverse events by severity. Including: * Local expected at injection site: erythema/redness; induration/hardening; pain; pruritus/itching; tenderness. * Systemic expected: fatigue; fever; flu-like symptoms; headache; myalgia/muscle pain; nausea; rash; vomiting
Time frame: Up to 7 days after each dose
Incidence of adverse events (AEs)
Number and percentage of adverse events reported spontaneously by the participant. The following summaries are planned: * Overview of TEAEs. * All TEAEs.events. * All TEAEs by relationship to study intervention. * All TEAEs leading to discontinuation. * All TEAEs leading to death. * All TEAEs by severity.
Time frame: Up to study day 61
Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI)
Number and percentage of serious adverse events and new-onset chronic illnesses as determined by discretion of the investigator. The following summaries are planned: * SAEs/NOCIs throughout study). * All SAEs considered at least possibly related to study intervention.
Time frame: Up to study day 224
Changes in safety laboratory results compared to baseline
Assessment of adverse changes from baseline in safety laboratory results (standard panels for hematology, blood chemistry and urinalysis) that meet criteria as an adverse event as described in "Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, FDA 2007".
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Time frame: Up to study day 61
Changes in vital signs compared to baseline
Assessment of changes in vital signs (SBP, DBP, HR, RR, oral body temp) that meet criteria as an adverse event as described in "Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, FDA 2007".
Time frame: Up to study day 61
Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA)
Anti-pneumolysin and anti-choline binding protein A serum immunoglobulin G antibody geometric mean titer as measured by enzyme-linked immunosorbent assay (ELISA) compared baseline. The anti-PLY and anti-CbpA antibody titers will be measured as \>=2- and \>=4-fold above baseline to determine GMTs and rates of seroconversion.
Time frame: Up to study day 224