The objective of this study is to assess the safety and immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine \[CHIKV VLP\], aluminum hydroxide adjuvanted).
Primary Objectives: 1. To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 (40 µg CHIKV VLP, alum-adjuvanted) as measured 21 days (Day 22) after vaccination. 2. To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 as measured 7 days (Day 8), 14 days (Day 15), and 56 days (Day 57) after vaccination. Secondary Objectives: 1\. To assess safety of a single adjuvanted dose of PXVX0317 in healthy adults.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
25
Adjuvanted formulation includes aluminum hydroxide
Johnson County ClinTrials
Lenexa, Kansas, United States
CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22
CHIKV SNA Seroresponse Rate (Titer \>=40) and Associated 95% Confidence Interval (CI) at Day 22
Time frame: 21 days post vaccination
CHIKV SNA GMT (Geometric Mean Titer) at Day 22
CHIKV SNA GMT and Associated 95% CI at Day 22
Time frame: 21 days post vaccination
CHIKV SNA Seroresponse Rates at Days 8, 15, and 57
CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57
Time frame: 56 days post vaccination
CHIKV SNA GMTs at Days 8, 15, and 57
CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57
Time frame: 56 days post vaccination
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
Time frame: 56 days post vaccination
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
Time frame: 56 days post vaccination
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57
Time frame: 56 days post vaccination
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57
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Time frame: 56 days post vaccination
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57
Time frame: 56 days post vaccination
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Number and Percentage of Participants with a CHIKV SNA Titer ≥15, 40, 60, 80, 100, 160, 640, and 4-fold Rise Over Baseline Thresholds at Days 8, 15, 22, and 57
Time frame: 56 days post vaccination
Incidence of Solicited Adverse Events (AE) Through Day 8
Incidence of Solicited AEs Through Day 8
Time frame: 7 days post vaccination
Incidence of Unsolicited AEs Through Day 29
Incidence of Unsolicited AEs Through Day 29
Time frame: 28 days post vaccination
Incidence of Adverse Events of Special Interest (AESI) Through Day 183
Incidence of AESIs Through Day 183
Time frame: 182 days post vaccination
Incidence of Serious Adverse Events (SAEs) Through Day 183
Incidence of SAEs Through Day 183
Time frame: 182 days post vaccination