This was a phase 2 parallel-group age- and gender-matched open label study in healthy adults 18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine) in prior recipients of other alphavirus vaccines versus alphavirus naïve controls.
It is currently unknown whether prior exposure to heterologous alphaviruses will enhance or interfere with immune responses to chikungunya virus (CHIKV) exposure or vaccination. The objective of this study was to evaluate the safety and immunogenicity of the chikungunya vaccine candidate PXVX0317 when administered to prior recipients of experimental alphavirus vaccines versus alphavirus naïve gender- and age-matched controls.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Virus Like Particle
United States Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response
Seroconversion, defined as a 4-fold or greater rise in neutralizing antibody against chikungunya virus, as determined by luciferase-based assay (NT80), induced by PXVX0317. PXVX0317 was administered to prior alphavirus vaccine recipients versus gender- and age-matched controls.
Time frame: Day 22 (21 days after vaccination)
Geometric Mean Titer of Anti-CHIKV Neutralizing Antibody Response
Evaluation of Geometric Mean Titer of Anti-CHIKV neutralizing antibodies, determined by luciferase-based assay (NT80), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.
Time frame: Day 1, 8, 22, 29, 57, 182
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response
Evaluation of seroconversion rate of Anti-CHIKV neutralizing antibodies, determined by luciferase-based assay (NT80), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.
Time frame: Day 8, 29, 57, 182
Percentage of Participants With Anti-CHIKV Neutralizing Antibody at or Above Selected Thresholds
Evaluation of Anti-CHIKV neutralizing antibody response, as determined by luciferase-based assay (NT80), via proportion of participants with titers of at least 40, 160 or 640 on Days 1, 8, 22, 29, 57 and 182.
Time frame: Day 1, 8, 22, 29, 57, 182
Geometric Mean Titer of Anti-CHIKV Total Antibody Response
Evaluation of Geometric Mean Titer of Anti-CHIKV total antibodies, determined by immunoassay (ELISA), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.
Time frame: Day 1, 22, 29
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Percentage of Participants With 4-fold Rise in Anti-CHIKV Total Antibody Response
Evaluation of seroconversion rate of Anti-CHIKV total antibodies, determined by immunoassay, on Days 22 and 29, where seroconversion was a 4-fold rise in titer over baseline.
Time frame: Day 22, 29
Geometric Mean Titer of Anti-VEEV Neutralizing Antibody Response
Evaluation of Geometric Mean Titer of Anti-VEEV neutralizing antibodies, determined by Plaque-Reduction Neutralization Test (PRNT80), in prior alphavirus vaccine recipients versus alphavirus-naïve controls
Time frame: Day 1, 22, 29
Number of Participants With Anti-CHIKV Total Antibody Titers of at Least 40,160 or 640
Evaluation of Anti-CHIKV total antibody titer, as determined by immunoassay (ELISA), via proportion of participants with titers of at least 40, 160 or 640 on Days 1, 22, and 29.
Time frame: Days 1, 22, and 29
Percentage of Participants With 4-fold Rise in Anti-VEEV Neutralizing Antibody Response
Evaluation of seroconversion rate of anti-VEEV neutralizing antibodies on Days 22 and 29 as determined by Plaque-Reduction Neutralization Test (PRNT80), where seroconversion is a 4-fold rise in titer over baseline.
Time frame: Day 22 and 29
Percentage of Participants With Anti-VEEV PRNT Neutralizing Activity at or Above Selected Thresholds
Evaluation of Anti-VEEV neutralizing antibody response, as determined by Plaque-Reduction Neutralization Test (PRNT80), via proportion of participants with titers of at least 40, 160 or 640 on Days 1, 22 and 29.
Time frame: Day 1, 22, 29
Geometric Mean Titer of Anti-VEEV Total Antibody Response
Evaluation of Geometric Mean Titer of Anti-VEEV total antibody as determined by an immunoassay (ELISA) in prior alphavirus vaccine recipients versus alphavirus-naïve controls.
Time frame: Day 1, 22, 29
Percentage of Participants With 4-fold Rise in Total ELISA IgG Antibody Against VEEV
Evaluation of seroconversion rate of Anti-VEEV total antibody, as determined by immunoassay (ELISA), on Days 22 and 29, where seroconversion is a 4-fold rise in titer over baseline.
Time frame: Day 22, 29
Number of Participants With Anti-VEEV Total Antibody Titers of at Least 40,160 or 640
Evaluation of Anti-VEEV total antibody titer, as determined by immunoassay (ELISA), via proportion of participants with titers of at least 40, 160, or 640 on Days 1, 22, and 29.
Time frame: Days 1, 22, and 29