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| Name | Class |
|---|---|
| Emergent BioSolutions | INDUSTRY |
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The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.
Co-primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - PXVX0317 | Experimental | PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant. |
|
| Group 2 - Placebo | Placebo Comparator | Placebo is comprised of formulation buffer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHIKV VLP/adjuvant | Biological | PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants | Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22. | 21 days postvaccination |
| Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22 | Anti-CHIKV SNA titer (NT80) GMT and associated 95 percent CIs at Day 22 for PXVX0317 and placebo. | 21 days postvaccination |
| Incidence of Solicited Adverse Events (AE) | Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | 7 days postvaccination |
| Incidence of Unsolicited AEs | Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | 28 days postvaccination |
| Incidence of Serious Adverse Events (SAE) | Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | 182 days postvaccination |
| Incidence of Medically Attended Adverse Events (MAAE) | Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | 182 days postvaccination |
| Incidence of Adverse Events of Special Interest (AESI) |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183 | Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) with associated 95 percent CIs at Day 15 and Day 183. | Day 15 and 183 (14 and 182 days postvaccination, respectively) |
| Anti-CHIKV SNA GMTs at Days 15 and 183 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Ajiboye, MD | Bavarian Nordic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suncoast Research Associates, LLC | Miami | Florida | 33173 | United States | ||
| Panax Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40158524 | Derived | Tindale LC, Richardson JS, Anderson DM, Mendy J, Muhammad S, Loreth T, Tredo SR, Ramanathan R, Jenkins VA, Bedell L, Ajiboye P; EBSI-CV-317-005 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1353-1361. doi: 10.1016/S0140-6736(25)00372-1. Epub 2025 Mar 27. | |
| 35709798 |
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This was a multicenter study conducted in the United States, using 10 sites. Healthy adult participants ≥65 year of age were enrolled in this study. Recruitment Period was from May 12, 2022 to December 02, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - PXVX0317 | PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant |
| FG001 | Group 2 - Placebo | Placebo is comprised of formulation buffer |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - PXVX0317 | PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant |
| BG001 | Group 2 - Placebo | Placebo is comprised of formulation buffer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants | Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22. | Immunogenicity Evaluable Population (IEP): All participants in the modified intent-to-treat (mITT) population who provide evaluable serum sample results for Day 22 within the required time frame of Day 19 through Day 27, inclusive; have no measurable anti-CHIKV SNA at Day 1; and have no important protocol deviation or other reason to be excluded as defined prior to unblinding. IEP is the primary population for all immunogenicity analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | 21 days postvaccination |
|
Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment)
An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
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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 | Group 1 - PXVX0317 | PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (24.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (24.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Bavarian Nordic A/S | 1-844-422-8274 | medical.information_na@bavarian-nordic.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 | Mar 31, 2023 | Oct 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2023 | Oct 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
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Participants will be randomized in a 1:1 ratio to receive PXVX0317 or placebo within each age stratum. Participants will be stratified in two age subgroups (≥65 to <75 and ≥75 years of age). This study will be conducted in the US, using up to 10 sites.
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| Placebo | Biological | Placebo is comprised of formulation buffer |
|
Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). |
| 182 days postvaccination |
Anti-CHIKV SNA GMTs with associated 95 percent CIs at Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined. |
| Day 15, and 183 (14 and 182 days postvaccination, respectively) |
| Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI) | Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 15, Day 22, and Day 183 for the IEP for all age strata combined. | Day 15, 22, and 183 (14, 21 and 182 days postvaccination, respectively) |
| Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline | Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 15, Day 22, and Day 183 for the IEP for all age strata combined. | Day 15, 22 and 183 (14, 21 and 182 days postvaccination, respectively) |
| Miami Lakes |
| Florida |
| 33014 |
| United States |
| Global Clinical Research Professionals (GCP) | St. Petersburg | Florida | 33705 | United States |
| AMR Kansas City | Kansas City | Missouri | 64114 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| DM Clinical Research CyFair | Houston | Texas | 77065 | United States |
| BHFC Research | San Antonio | Texas | 78249 | United States |
| DM Clinical Research Tomball | Tomball | Texas | 77375 | United States |
| Spaulding Clinical | West Bend | Wisconsin | 53095 | United States |
| Derived |
| Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13. |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Baseline Anti-CHIKV SNA Serostatus | Count of Participants | Participants |
|
| OG001 | Group 2 - Placebo | Placebo is comprised of formulation buffer |
|
|
|
| Primary | Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22 | Anti-CHIKV SNA titer (NT80) GMT and associated 95 percent CIs at Day 22 for PXVX0317 and placebo. | Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window (Day 19 through 27, inclusive), had no measurable anti-CHIKV human SNA assay titer at Day 1 (i.e., seronegative at baseline; participants missing a Day 1 titer were excluded from IEP), and had no important exclusionary protocol deviation or other reason for exclusion as defined prior to unblinding). | Posted | Geometric Mean | 95% Confidence Interval | Titer | 21 days postvaccination |
|
|
|
|
| Primary | Incidence of Solicited Adverse Events (AE) | Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | Posted | Count of Participants | Participants | 7 days postvaccination |
|
|
|
| Primary | Incidence of Unsolicited AEs | Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | Safety population (vaccinated participants who provided safety assessment data), All ages pooled. | Posted | Count of Participants | Participants | 28 days postvaccination |
|
|
|
| Primary | Incidence of Serious Adverse Events (SAE) | Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | Safety population (vaccinated participants who provided safety assessment data), All ages pooled. | Posted | Count of Participants | Participants | 182 days postvaccination |
|
|
|
| Primary | Incidence of Medically Attended Adverse Events (MAAE) | Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | Safety population (vaccinated participants who provided safety assessment data), All ages pooled. | Posted | Count of Participants | Participants | 182 days postvaccination |
|
|
|
| Primary | Incidence of Adverse Events of Special Interest (AESI) | Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population). | Safety population (vaccinated participants who provided safety assessment data), All ages pooled. | Posted | Count of Participants | Participants | 182 days postvaccination |
|
|
|
| Secondary | Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183 | Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) with associated 95 percent CIs at Day 15 and Day 183. | Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window, had no measurable anti-CHIKV human SNA assay titer at Day 1, and had no important protocol deviation deemed exclusionary or other reason to be excluded as defined prior to unblinding). Number analyzed is number of participants with a sample result available at the indicated visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 15 and 183 (14 and 182 days postvaccination, respectively) |
|
|
|
|
| Secondary | Anti-CHIKV SNA GMTs at Days 15 and 183 | Anti-CHIKV SNA GMTs with associated 95 percent CIs at Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined. | Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window, had no measurable anti-CHIKV human SNA assay titer at Day 1, and had no important protocol deviation deemed exclusionary or other reason to be excluded as defined prior to unblinding). Number analyzed is number of participants with a sample result available at the indicated visit. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 15, and 183 (14 and 182 days postvaccination, respectively) |
|
|
|
|
| Secondary | Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI) | Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 15, Day 22, and Day 183 for the IEP for all age strata combined. | Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window, had no measurable anti-CHIKV human SNA assay titer at Day 1, and had no important protocol deviation deemed exclusionary or other reason to be excluded as defined prior to unblinding). Number analyzed is number of participants with a sample result available at both Day 1 and the indicated visit. | Posted | Geometric Mean | 95% Confidence Interval | Fold increase in Anti-CHIKV SNA titre | Day 15, 22, and 183 (14, 21 and 182 days postvaccination, respectively) |
|
|
|
|
| Secondary | Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline | Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 15, Day 22, and Day 183 for the IEP for all age strata combined. | Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window, had no measurable anti-CHIKV human SNA assay titer at Day 1, and had no important protocol deviation deemed exclusionary or other reason to be excluded as defined prior to unblinding). Number analyzed is number of participants with a sample result available at the indicated visit. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 15, 22 and 183 (14, 21 and 182 days postvaccination, respectively) |
|
|
|
|
| 1 |
| 206 |
| 4 |
| 206 |
| 46 |
| 206 |
| EG001 | Group 2 - Placebo | Placebo is comprised of formulation buffer | 1 | 207 | 3 | 207 | 44 | 207 |
| Glaucoma | Eye disorders | MedDRA (24.1) | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA (24.1) | Non-systematic Assessment |
|
This is a multi-center study and agreement with investigators depends on the individual site contact.
| D000096724 |
| Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| Day 183 |
|
|
| Day 183 | Chi-squared | p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. | <0.0001 | Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed | Percent Difference | 74.4 | 2-Sided | 95 | 67.1 | 80.1 | Seroresponse rate difference is (PXVX0317 minus placebo). | Superiority |
| Day 183 |
|
|
Day 183 |
| ANOVA |
ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups. |
| <0.0001 |
| [GMT Ratio] |
| 28 |
| 2-Sided |
| 95 |
| 22 |
| 35 |
Ratio of GMTs is (PXVX0317:placebo) |
| Superiority |
| Day 22 |
|
|
| Day 183 |
|
|
Day 22
| t-test, 2 sided |
| <0.0001 |
GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups. |
| Superiority |
| Day 183 | t-test, 2 sided | <0.0001 | GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups. | Superiority |
| SNA titers ≥ 15 at Day 22 |
|
|
| SNA titers ≥ 15 at Day 183 |
|
|
| ≥4-fold rise over baseline at Day 15 |
|
|
| ≥4-fold rise over baseline at Day 22 |
|
|
| ≥4-fold rise over baseline at Day 183 |
|
|
SNA titers ≥15 at Day 22 |
| Chi-squared |
p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. |
| <0.0001 |
| Percent Difference |
| 94.1 |
| 2-Sided |
| 95 |
| 89.2 |
| 96.5 |
Seroresponse rate difference is (PXVX0317 minus placebo). |
| Superiority |
| SNA titers ≥15 at Day 183 | Chi-squared | p-value is from a two-sided chi-square test of equality of SNA response percentages between groups. | <0.0001 | Percent Difference | 91.8 | 2-Sided | 95 | 86.3 | 94.8 | SNA response rate difference is (PXVX0317 minus placebo). | Superiority |
| ≥4-fold rise over baseline at Day 15 | Chi-squared | <0.0001 | p-value is from a two-sided chi-square test of equality of SNA response percentages between groups. | Percent Difference | 82.8 | 2-Sided | 95 | 75.9 | 87.5 | SNA response rate difference is (PXVX0317 minus placebo). | Superiority |
| ≥4-fold rise over baseline at Day 22 | Chi-squared | p-value is from a two-sided chi-square test of equality of SNA response percentages between groups. | <0.0001 | Percent Difference | 88.3 | 2-Sided | 95 | 82.4 | 92.0 | SNA response rate difference is (PXVX0317 minus placebo). | Superiority |
| ≥4-fold rise over baseline at Day 183 | Chi-squared | p-value is from a two-sided chi-square test of equality of SNA response percentages between groups. | <0.0001 | Percent Difference | 82.0 | 2-Sided | 95 | 75.2 | 86.8 | SNA response rate difference is (PXVX0317 minus placebo). | Superiority |