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| Name | Class |
|---|---|
| Emergent BioSolutions | INDUSTRY |
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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:
Secondary Objectives:
1. To assess safety of a single adjuvanted dose of PXVX0317 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PXVX0317 (CHIKV VLP, alum-adjuvanted) vaccine | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHIKV VLP, adjuvanted | Biological | Adjuvanted formulation includes aluminum hydroxide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 21 days post vaccination |
| CHIKV SNA GMT (Geometric Mean Titer) at Day 22 | CHIKV SNA GMT and Associated 95% CI at Day 22 | 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 | 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 | 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 | 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 | 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 | 56 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Solicited Adverse Events (AE) Through Day 8 | Incidence of Solicited AEs Through Day 8 | 7 days post vaccination |
| Incidence of Unsolicited AEs Through Day 29 | Incidence of Unsolicited AEs Through Day 29 |
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Inclusion Criteria:
Able and willing to provide informed consent voluntarily signed by participant.
Any gender, 18 to 45 years of age (inclusive).
Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, and screening laboratory assessments.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Ajiboye | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County ClinTrials | Lenexa | Kansas | 66219 | United States |
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Participants were recruited at 1 U.S. site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | mITT | Posted | Number | 95% Confidence Interval | Percentage of participants | 21 days post vaccination |
|
|
AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sufia Muhammad | Emergent BioSolutions | 346-732-7331 | muhammads@ebsi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2021 | Jan 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2021 | Jan 11, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 26, 2021 | Jan 11, 2023 | ICF_002.pdf |
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Open Label Safety and Immunogenicity
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Open Label
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| 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 | 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 | 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 | 56 days post vaccination |
| 28 days post vaccination |
| Incidence of Adverse Events of Special Interest (AESI) Through Day 183 | Incidence of AESIs Through Day 183 | 182 days post vaccination |
| Incidence of Serious Adverse Events (SAEs) Through Day 183 | Incidence of SAEs Through Day 183 | 182 days post vaccination |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Day 1 predose (baseline) geometric mean anti-chikungunya luciferase neutralizing antibody titer. | Day 1 predose (baseline) geometric mean anti-chikungunya luciferase neutralizing antibody titer. Values below the lower limit of quantitation of 15 were imputed as half the lower limit of quantitation or 7.5. | Geometric Mean | Full Range | Titer |
|
| Participants |
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| Primary | CHIKV SNA GMT (Geometric Mean Titer) at Day 22 | CHIKV SNA GMT and Associated 95% CI at Day 22 | mITT | Posted | Geometric Mean | 95% Confidence Interval | Titer | 21 days post vaccination |
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| 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 | mITT | Posted | Number | 95% Confidence Interval | Percentage of participants | 56 days post vaccination |
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| Primary | CHIKV SNA GMTs at Days 8, 15, and 57 | CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57 | mITT | Posted | Geometric Mean | 95% Confidence Interval | Titer | 56 days post vaccination |
|
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| 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 | mITT | Posted | Geometric Mean | 95% Confidence Interval | Titer | 56 days post vaccination |
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| 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 | mITT | Posted | Geometric Mean | 95% Confidence Interval | Titer | 56 days post vaccination |
|
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| 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 | mITT | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | 56 days post vaccination |
|
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| 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 | mITT | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | 56 days post vaccination |
|
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| 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 | mITT | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | 56 days post vaccination |
|
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| 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 | mITT | Posted | Number | 95% Confidence Interval | Percentage of participants | 56 days post vaccination |
|
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| Secondary | Incidence of Solicited Adverse Events (AE) Through Day 8 | Incidence of Solicited AEs Through Day 8 | Safety population | Posted | Count of Participants | Participants | 7 days post vaccination |
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| Secondary | Incidence of Unsolicited AEs Through Day 29 | Incidence of Unsolicited AEs Through Day 29 | Safety population | Posted | Count of Participants | Participants | 28 days post vaccination |
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| Secondary | Incidence of Adverse Events of Special Interest (AESI) Through Day 183 | Incidence of AESIs Through Day 183 | Safety population | Posted | Count of Participants | Participants | 182 days post vaccination |
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| Secondary | Incidence of Serious Adverse Events (SAEs) Through Day 183 | Incidence of SAEs Through Day 183 | Safety population | Posted | Count of Participants | Participants | 182 days post vaccination |
|
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|
| 0 |
| 25 |
| 0 |
| 25 |
| 17 |
| 25 |
| Injection site pain | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Chills | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA (24.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
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PI may publish or release study data after the earlier of (a) the date of publication of a multi-center publication coordinated by Sponsor on the study data, or (b) the date of submission of the study data by Sponsor to regulatory authorities for regulatory approval; provided that PI furnishes Sponsor with a copy of any proposed publication or release at least ninety days in advance of the proposed submission or presentation date for review. PI must acknowledge Sponsor on any publication.
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| Day 57 titer at or above 40 |
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| Day 57 |
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| Day 22 |
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| Day 57 |
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| Day 22 |
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| Day 57 |
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| Day 22 |
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| Day 57 |
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| Day 22 |
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| Day 57 |
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| Day 22 |
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| Day 57 |
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| Day 8 : Titer at or above 60 |
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| Day 8 : Titer at or above 80 |
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| Day 8 : Titer at or above 100 |
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| Day 8 : Titer at or above 160 |
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| Day 8 : Titer at or above 640 |
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| Day 8 : Titer at or above 4-fold rise over baseline |
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| Day 15 : Titer at or above 15 |
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| Day 15 : Titer at or above 40 |
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| Day 15 : Titer at or above 60 |
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| Day 15 : Titer at or above 80 |
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| Day 15 : Titer at or above 100 |
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| Day 15 : Titer at or above 160 |
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| Day 15 : Titer at or above 640 |
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| Day 15 : Titer at or above 4-fold rise over baseline |
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| Day 22 : Titer at or above 15 |
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| Day 22 : Titer at or above 40 |
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| Day 22 : Titer at or above 60 |
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| Day 22 : Titer at or above 80 |
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| Day 22 : Titer at or above 100 |
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| Day 22 : Titer at or above 160 |
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| Day 22 : Titer at or above 640 |
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| Day 22 : Titer at or above 4-fold rise over baseline |
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| Day 57 : Titer at or above 15 |
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| Day 57 : Titer at or above 40 |
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| Day 57 : Titer at or above 60 |
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| Day 57 : Titer at or above 80 |
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| Day 57 : Titer at or above 100 |
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| Day 57 : Titer at or above 160 |
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| Day 57 : Titer at or above 640 |
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| Day 57 : Titer at or above 4-fold rise over baseline |
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| Title | Measurements |
|---|
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| Chills |
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| Fatigue |
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| Headache |
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| Myalgia |
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| Arthralgia |
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| Nausea |
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| Any local solicited AE |
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| Injection site pain |
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| Injection site redness |
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| Injection site swelling |
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| Title | Measurements |
|---|---|
|
| Immune system disorders |
|
| Anaphylactic reaction |
|
| Infections and infestations |
|
| Sinusitis |
|
| Musculoskeletal and connective tissue disorders |
|
| Myalgia |
|
| Nervous system disorders |
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| Dizziness |
|
| Presyncope |
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| Headache |
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| Psychiatric disorders |
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| Anxiety |
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| Respiratory, thoracic and mediastinal disorders |
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| Rhinorrhoea |
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| Oropharyngeal pain |
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| Vascular disorders |
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| Hot flush |
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