Chikungunya Virus
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALCHIKV VLP, adjuvanted
Adjuvanted formulation includes aluminum hydroxide
Sponsors
Emergent BioSolutions
Bavarian Nordic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open Label
Intervention model description
Open Label Safety and Immunogenicity
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to provide informed consent voluntarily signed by participant. 2. Any gender, 18 to 45 years of age (inclusive). 3. Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, and screening laboratory assessments. 4. Women who are either: (i). Not of childbearing potential (CBP): pre-menarche, anatomically sterile, or post-menopausal (defined as ≥12 months without menses) or (ii). Meeting all the following criteria: Negative urine pregnancy test at screening visit; and Negative urine pregnancy test immediately prior to dosing at Day 1; and using an acceptable method of contraception (if female of childbearing potential) for the duration of participation, such as: Hormonal contraceptives (e.g., implants, pills, patches) initiated ≥ 30 days prior to dosing or; Intrauterine device (IUD) inserted ≥30 days prior to dosing or; double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap).
Exclusion criteria
1. Currently pregnant, breastfeeding, or planning to become pregnant during the study. 2. Body Mass Index (BMI) ≥35 kg/m2. 3. Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV). 4. History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP). 5. History of known congenital or acquired immunodeficiency that could impact response to vaccination (e.g., leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis). 6. Prior or anticipated receipt of immunomodulatory or immunosuppressive therapy from six months prior to screening through Day 64. 7. Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 64. 8. Acute disease within the last 14 days (participants with an acute mild febrile illness can be considered for a deferral of vaccination two weeks after the illness has resolved and treatment has been completed). 9. Clinically significant cardiac, pulmonary, respiratory, rheumatologic, or other chronic disease, in the opinion of the Investigator. This may include chronic illness requiring hospitalization in the last one month prior to screening. 10. Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation. 11. Receipt or anticipated receipt of any vaccine from 30 days prior to screening through Day 64. 12. Prior receipt of an investigational CHIKV vaccine/product. 13. Detectable baseline anti-CHIKV IgG antibody as determined by ELISA. 14. Any other condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study, creates an unacceptable risk to the participant, or may interfere with the conduct of the study or validity of the data. 15. Restricted venous access that would prevent the collection of plasma and serum necessary for participation. 16. Weight \<110 pounds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | 56 days post vaccination | 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 |
| CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57 | 56 days post vaccination | CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57 |
| Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57 | 56 days post vaccination | GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57 |
| GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57 | 56 days post vaccination | GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57 |
| GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57 | 56 days post vaccination | GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57 |
| CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22 | 21 days post vaccination | CHIKV SNA Seroresponse Rate (Titer \>=40) and Associated 95% Confidence Interval (CI) at Day 22 |
| CHIKV SNA GMT (Geometric Mean Titer) at Day 22 | 21 days post vaccination | CHIKV SNA GMT and Associated 95% CI at Day 22 |
| CHIKV SNA Seroresponse Rates at Days 8, 15, and 57 | 56 days post vaccination | CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57 |
| CHIKV SNA GMTs at Days 8, 15, and 57 | 56 days post vaccination | CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57 |
| CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57 | 56 days post vaccination | CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Unsolicited AEs Through Day 29 | 28 days post vaccination | Incidence of Unsolicited AEs Through Day 29 |
| Incidence of Adverse Events of Special Interest (AESI) Through Day 183 | 182 days post vaccination | Incidence of AESIs Through Day 183 |
| Incidence of Solicited Adverse Events (AE) Through Day 8 | 7 days post vaccination | Incidence of Solicited AEs Through Day 8 |
| Incidence of Serious Adverse Events (SAEs) Through Day 183 | 182 days post vaccination | Incidence of SAEs Through Day 183 |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 1 U.S. site.
Participants by arm
| Arm | Count |
|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 34.1 years STANDARD_DEVIATION 5.8 |
| Day 1 predose (baseline) geometric mean anti-chikungunya luciferase neutralizing antibody titer. | 7.5 Titer |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 17 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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
Population: mITT
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57 | Day 8 | 0.71 Titer |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57 | Day 15 | 1.1 Titer |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57 | Day 22 | 1.5 Titer |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57 | Day 57 | 1.2 Titer |
Primary
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
Population: mITT
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57 | Day 8 | 1.2 Titer |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57 | Day 15 | 5.0 Titer |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57 | Day 22 | 6.2 Titer |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57 | Day 57 | 2.9 Titer |
Primary
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
Population: mITT
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV SNA GMT (Geometric Mean Titer) at Day 22 | 2365.2 Titer |
Primary
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
Population: mITT
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV SNA GMTs at Days 8, 15, and 57 | Day 8 | 117.4 Titer |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV SNA GMTs at Days 8, 15, and 57 | Day 15 | 1397.1 Titer |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV SNA GMTs at Days 8, 15, and 57 | Day 57 | 1069.7 Titer |
Primary
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
Population: mITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV SNA Seroresponse Rates at Days 8, 15, and 57 | Day 8 titer at or above 40 | 76.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV SNA Seroresponse Rates at Days 8, 15, and 57 | Day 15 titer at or above 40 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV SNA Seroresponse Rates at Days 8, 15, and 57 | Day 57 titer at or above 40 | 100.0 Percentage of participants |
Primary
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
Population: mITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22 | 100.0 Percentage of participants |
Primary
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
Population: mITT
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57 | Day 8 | 15.6 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57 | Day 15 | 186.3 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57 | Day 22 | 315.4 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57 | Day 57 | 142.6 Fold increase |
Primary
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
Time frame: 56 days post vaccination
Population: mITT
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57 | Day 8 | 0.93 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57 | Day 15 | 1.4 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57 | Day 22 | 2.0 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57 | Day 57 | 1.7 Fold increase |
Primary
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
Population: mITT
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57 | Day 8 | 3.1 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57 | Day 15 | 12.6 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57 | Day 22 | 15.6 Fold increase |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57 | Day 57 | 7.2 Fold increase |
Primary
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
Population: mITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 8 : Titer at or above 15 | 96.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 8 : Titer at or above 40 | 76.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 8 : Titer at or above 60 | 68.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 8 : Titer at or above 80 | 56.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 8 : Titer at or above 100 | 52.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 8 : Titer at or above 160 | 48.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 8 : Titer at or above 640 | 12.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 8 : Titer at or above 4-fold rise over baseline | 88.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 15 : Titer at or above 15 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 15 : Titer at or above 40 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 15 : Titer at or above 60 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 15 : Titer at or above 80 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 15 : Titer at or above 100 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 15 : Titer at or above 160 | 96.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 15 : Titer at or above 640 | 76.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 15 : Titer at or above 4-fold rise over baseline | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 22 : Titer at or above 15 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 22 : Titer at or above 40 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 22 : Titer at or above 60 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 22 : Titer at or above 80 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 22 : Titer at or above 100 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 22 : Titer at or above 160 | 96.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 22 : Titer at or above 640 | 92.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 22 : Titer at or above 4-fold rise over baseline | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 57 : Titer at or above 15 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 57 : Titer at or above 40 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 57 : Titer at or above 60 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 57 : Titer at or above 80 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 57 : Titer at or above 100 | 100.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 57 : Titer at or above 160 | 95.8 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 57 : Titer at or above 640 | 75.0 Percentage of participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 | Day 57 : Titer at or above 4-fold rise over baseline | 100.0 Percentage of participants |
Secondary
Incidence of Adverse Events of Special Interest (AESI) Through Day 183
Incidence of AESIs Through Day 183
Time frame: 182 days post vaccination
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Adverse Events of Special Interest (AESI) Through Day 183 | 0 Participants |
Secondary
Incidence of Serious Adverse Events (SAEs) Through Day 183
Incidence of SAEs Through Day 183
Time frame: 182 days post vaccination
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Serious Adverse Events (SAEs) Through Day 183 | 0 Participants |
Secondary
Incidence of Solicited Adverse Events (AE) Through Day 8
Incidence of Solicited AEs Through Day 8
Time frame: 7 days post vaccination
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Any systemic solicited AE | 12 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Fever | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Chills | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Fatigue | 8 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Headache | 7 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Myalgia | 5 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Arthralgia | 2 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Nausea | 2 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Any local solicited AE | 14 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Injection site pain | 14 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Injection site redness | 0 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Injection site swelling | 0 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Solicited Adverse Events (AE) Through Day 8 | Any solicited AE | 17 Participants |
Secondary
Incidence of Unsolicited AEs Through Day 29
Incidence of Unsolicited AEs Through Day 29
Time frame: 28 days post vaccination
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Myalgia | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Participants with any unsolicited AEs | 8 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | General disorders and administration site conditions | 2 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Vessel puncture site bruise | 2 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Immune system disorders | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Anaphylactic reaction | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Infections and infestations | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Sinusitis | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Musculoskeletal and connective tissue disorders | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Nervous system disorders | 5 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Dizziness | 2 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Presyncope | 3 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Headache | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Psychiatric disorders | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Anxiety | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Respiratory, thoracic and mediastinal disorders | 2 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Rhinorrhoea | 2 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Oropharyngeal pain | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Vascular disorders | 1 Participants |
| PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine | Incidence of Unsolicited AEs Through Day 29 | Hot flush | 1 Participants |