The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.
Co-primary Objectives: * To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo) in adults ≥65 years of age. * To evaluate the safety of PXVX0317 in adults ≥65 years of age Secondary Objectives: * To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15 and Day 183, as measured by GMT and seroresponse rate. * To compare the anti-CHIKV SNA response to PXVX0317 and placebo in participants ≥65 to \<75 and ≥75 years of age as measured by GMT and seroresponse rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
413
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
Placebo is comprised of formulation buffer
Suncoast Research Associates, LLC
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Global Clinical Research Professionals (GCP)
St. Petersburg, Florida, United States
Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22.
Time frame: 21 days postvaccination
Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22
Anti-CHIKV SNA titer (NT80) GMT and associated 95 percent CIs at Day 22 for PXVX0317 and placebo.
Time frame: 21 days postvaccination
Incidence of Solicited Adverse Events (AE)
Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Time frame: 7 days postvaccination
Incidence of Unsolicited AEs
Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Time frame: 28 days postvaccination
Incidence of Serious Adverse Events (SAE)
Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Time frame: 182 days postvaccination
Incidence of Medically Attended Adverse Events (MAAE)
Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Time frame: 182 days postvaccination
Incidence of Adverse Events of Special Interest (AESI)
Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
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AMR Kansas City
Kansas City, Missouri, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
DM Clinical Research CyFair
Houston, Texas, United States
BHFC Research
San Antonio, Texas, United States
DM Clinical Research Tomball
Tomball, Texas, United States
Spaulding Clinical
West Bend, Wisconsin, United States
Time frame: 182 days postvaccination
Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) with associated 95 percent CIs at Day 15 and Day 183.
Time frame: Day 15 and 183 (14 and 182 days postvaccination, respectively)
Anti-CHIKV SNA GMTs at Days 15 and 183
Anti-CHIKV SNA GMTs with associated 95 percent CIs at Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Time frame: Day 15, and 183 (14 and 182 days postvaccination, respectively)
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)
Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
Time frame: Day 15, 22, and 183 (14, 21 and 182 days postvaccination, respectively)
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
Time frame: Day 15, 22 and 183 (14, 21 and 182 days postvaccination, respectively)