The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of CHIKV VLP vaccine in adult and adolescent participants and to evaluate CHIKV VLP booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial CHIKV VLP vaccination.
Primary Objectives: * To evaluate the long-term immunogenicity of CHIKV VLP vaccine in healthy adult and adolescent participants as measured by proportion of participants maintaining an anti-CHIKV serum neutralizing antibody (SNA) titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years postvaccination in feeder studies EBSI-CV-317-004 (NCT05072080) and EBSI-CV-317-005 (NCT05349617). * To assess the vaccine-induced SNA titers by a booster dose of CHIKV VLP vaccine at 3, 4, or 5 years post-initial vaccination in feeder studies EBSI-CV- 317-004 and EBSI-CV-317-005. * To evaluate the safety and tolerability of CHIKV VLP vaccine in all participants. * To evaluate the safety and tolerability of a booster vaccination and compare with safety and tolerability reported post-initial vaccination of CHIKV VLP vaccine under feeder studies EBSI-CV-317-004 and EBSI-CV-317-005 in healthy adults and adolescents. Secondary Objectives: * To evaluate the long-term immunogenicity of CHIKV VLP vaccine in healthy adult and adolescent participants as measured by anti-CHIKV SNA geometric mean titers (GMTs) at yearly intervals up to 5 years post-initial vaccination in feeder studies EBSI-CV-317-004 and EBSI-CV-317-005. * To evaluate the immune response to a booster vaccination and compare this response to that reported post-initial vaccination of CHIKV VLP vaccine under feeder studies EBSI-CV-317-004 and EBSI-CV-317-005 in healthy adults and adolescents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
800
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP) 40mg, aluminum hydroxide 2% adjuvant, and formulation buffer supplied as a single dose of 0.8 mL in a pre-filled syringe, to be administered via intramuscular (IM) injection in the deltoid muscle.
Placebo is comprised of formulation buffer supplied as a single dose of 0.8 mL in a pre-filled syringe administered via IM injection in the deltoid muscle.
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
Proportion of participants maintaining a preboost anti-CHIKV SNA titer ≥100 at yearly intervals up to 5 years post-initial vaccination
For all groups using the immunogenicity evaluable population (IEP) the proportion of participants maintaining a preboost anti-CHIKV SNA titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years post-initial vaccination in one of the feeder studies; only prebooster data will be summarized.
Time frame: 5 years post-initial vaccination in feeder study EBSI-CV-317-004 or EBSI-CV317-005 until booster
Proportion of vaccine boosted participants with composite booster response at 21 days after booster vaccination
For IEP participants who receive a CHIKV VLP vaccine booster (Groups 1a, 2a, and 3a), proportion of participants with a boost response is defined as a composite of: * ≥4-fold rise in anti-CHIKV SNA titer from prebooster to postbooster measured at 21 days after booster for participants with a prebooster titer ≥100 OR * Anti-CHIKV SNA titer ≥100 and ≥4-fold increase in anti-CHIKV SNA titer from prebooster to postbooster measured at 21 days after booster vaccination for participants with a prebooster titer \<100. Note: Prebooster is the last SNA sample prior to booster dose, ideally the sample on boost day prior to booster dose administration but can be the time point prior if the boost day sample is missed or incorrectly processed.
Time frame: 21 days after booster vaccination
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at yearly intervals
For all groups using the IEP, anti-CHIKV SNA GMTs preboost at yearly intervals up to 5 years post-initial CHIKV VLP vaccination in feeder study EBSI-CV-317-004 or EBSI-CV-317-005; only prebooster data will be summarized.
Time frame: 5 years post-initial vaccination in feeder study EBSI-CV-317-004 or EBSI-CV-317-005 until booster
Anti-CHIKV SNA GMTs at 21 days postboost
Anti-CHIKV SNA GMTs in Groups 1a, 2a, and 3a (PXVX0317 IEP booster population), at 21 days postboost.
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Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States
Optimal Research, LLC
Melbourne, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, United States
Optimal Research, LLC
Peoria, Illinois, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States
...and 14 more locations
Time frame: 21 days postboost for Groups 1a, 2a, and 3a
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI) Prebooster to Postbooster
For IEP participants who receive a CHIKV VLP vaccine booster (Groups 1a, 2a, and 3a) and have a 21-day postbooster SNA titer, GMFI from prebooster anti-CHIKV SNA titer to 21 days postbooster anti-CHIKV SNA titer and at yearly intervals up to 5 years post-initial vaccination in feeder study EBSI-CV-317-004 or EBSI-CV-317-005.
Time frame: 21 days after booster vaccination and 5 years post-initial vaccination in feeder study EBSI-CV-317-004 or EBSI-CV-317-005
Booster Response at 21 Days Relative to 21-day Response in Feeder Study EBSI-CV-317-004 or EBSI-CV-317-005
For IEP participants who receive a CHIKV VLP vaccine booster (Groups 1a, 2a, and 3a) and have a 21-day postboost SNA titer, GMFI from feeder study EBSI-CV-317-004 or EBSI-CV-317-005 Day 22 SNA titer to 21-day postbooster SNA titer in the rollover study.
Time frame: 21 days after booster vaccination