Chikungunya Virus
Conditions
Keywords
Chikungunya, PXVX0317, CHIKV VLP, vaccine, immunogenicity, efficacy, safety, VIMKUNYA, adolescents, adults
Brief summary
Study EBSI-CV-317-007 is a field study to evaluate the efficacy, immunogenicity, and safety of CHIKV VLP vaccine. The study was designed using infectious disease models and advanced analytics to guide region and clinical site prioritization, define the timing of study activities, and optimize the study parameters to local epidemiological conditions for CHIKV disease to overcome the challenges of assessing efficacy for CHIKV VLP vaccine.
Interventions
BIOLOGICALCHIKV VLP vaccine
CHIKV VLP vaccine is comprised of 40 µg CHIKV VLP adsorbed on aluminum hydroxide (corresponding to approximately 300 µg of aluminum and stabilized with formulation buffer). CHIKV VLP vaccine is supplied as a single dose of 0.8 mL in a single use pre-filled syringe administered via IM injection in the deltoid muscle.
BIOLOGICALPlacebo
Placebo is comprised of formulation buffer supplied as a single dose of 0.8 mL in a single use pre-filled syringe administered via IM injection in the deltoid muscle.
Sponsors
Bavarian Nordic
Walter Reed Army Institute of Research (WRAIR)
Congressionally Directed Medical Research Programs
United States Department of Defense
Pharmaceutical Product Development, (PPD) LLC
Armed Forces Research Institute of Medical Services
Q-square Business Intelligence, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be stratified by age group by age group (12 to \<18, 18 to 64, and ≥65 years old) and site, and randomized in a 1:1 ratio to receive either a single intramuscular (IM) dose of 40 µg CHIKV VLP vaccine or placebo at Day 1.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). Must verbalize understanding of the reason for and the procedures needed for the study and be willing to stay in the study for its entire duration. 2. Male or nonpregnant female 12 years of age and older. 3. In stable health per the investigator, and no hospital admission or major surgical procedure in the last 30 days before investigational product administration. 4. Women who are either: 1. Not of CBP: premenarchal, surgically sterile (at least 6 weeks post bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment). or 2. Meeting all the below criteria: * Negative urine pregnancy test at screening visit * Negative urine pregnancy test immediately prior to dosing * Using an acceptable form of contraception per local standards and agree to use this for at least 8 weeks after investigational product administration Note: Contraception requirements do not apply for participants in exclusively same-sex relationships and these participants should have no plans to become pregnant by any other means for at least 8 weeks after investigational product administration.
Exclusion criteria
1. Currently pregnant or breastfeeding. 2. Participation or planned participation in an investigational clinical study within 30 days of Day 1 (investigational product administration) and for the duration of the study. Note: Participation in an observational trial/study or follow-up phase of a trial/study may be eligible; however, participation in any other study should be discussed with the MM prior to enrollment. 3. History of severe allergic reaction or anaphylaxis to any component of the investigational product. 4. Prior receipt of any CHIKV vaccine (or therapeutic) or participation in a prior interventional CHIKV trial/study. 5. Prior documented, laboratory confirmed CHIKV disease. 6. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to investigational product administration (eg, leukemia, lymphoma, malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Notes: i) history of basal cell and squamous cell carcinoma of the skin or carcinoma in situ of the cervix considered cured is not exclusionary; ii) history of malignancy considered cured from over 5 years from the date of screening with minimal risk of reoccurrence or relapse is not exclusionary; iii) documented controlled HIV infection (most recent tests show undetectable viral load and a CD4 cell count over 350 at the time of investigational product administration) is not exclusionary. 7. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications including hyperimmune products, monoclonal antibody therapies, systemic corticosteroids, and/or therapy with alkylating agents, antimetabolites, or radiation from 6 months prior to screening through Day 22 visit (21 days \[-3/+5\] after investigational product administration). Note: i) for systemic corticosteroid uses at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within 90 days of screening through Day 22 visit is exclusionary, and ii) use of inhaled, intranasal, topical, or ocular steroids is not exclusionary. 8. Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22 visit. 9. Unstable medical condition in the last 30 days prior to Day 1. 10. Acute illness with or without fever (oral temperatures ≥38.0 ºC \[100.4 °F\]) within 14 days prior to investigational product administration. 11. Medical or social condition (eg, substance abuse) that could have an impact on the participant's ability to be compliant with study procedures/visits, as determined by the investigator. 12. Plans to travel outside the study area or move away for more than 3 consecutive months and will not be available for follow up at the site. 13. Identified as an investigator or employee of an investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse) of the investigator or employee with direct involvement in the proposed study, or identified as an employee of Bavarian Nordic, their families, contractors, agents, business partners, or anyone with a financial interest in the outcome of the study. 14. Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of laboratory-confirmed acute CHIKV disease | From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination | Laboratory-confirmed acute CHIKV disease is defined by the presence of fever, one or more of arthralgia, myalgia or rash, and reverse transcription-quantitative polymerase chain reaction (RT-qPCR) confirmation of CHIKV ribonucleic acid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of laboratory-confirmed chronic CHIKV disease | 98 days postvaccination through end of study follow-up, up to 1095 days postvaccination | Laboratory-confirmed chronic CHIKV disease is defined as the persistence of at least one of the articular manifestations (continuous or recurrent pain, rigidity, edema) for \>12 weeks after the onset of laboratory confirmed acute CHIKV disease. |
| Incidence of laboratory-confirmed severe CHIKV disease. | 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination | Laboratory-confirmed severe CHIKV disease is defined as a laboratory confirmed acute CHIKV disease presenting with dysfunction of at least one organ or system that threatens life and requires hospitalization. |
| Number of participants with Solicited or Local Adverse Events | Within 7 days postvaccination | In the Safety Subset, the number and percentage of participants with local and systemic reactogenicity events through 7 days postvaccination. |
| Number of participants with Unsolicited Adverse Events | Within 28 days postvaccination | In the Safety Subset, the number and percentage of participants with unsolicited adverse events through 28 days postvaccination. |
| Number of Participants with Serious Adverse Events | Through end of study follow-up, up to 1095 days postvaccination | For all study participants who receive investigational product, number and percentage of participants with Serious Adverse Events (SAEs). Note: All participants will be followed for a minimum duration of 6 months following investigational product administration. |
| Number of Participants with Adverse Events of Special Interest | Through end of study follow-up, up to 1095 days postvaccination | Adverse events of special interest are defined as the occurrence of new onset or worsening arthralgia that is medically attended and are not associated with a febrile disease case. For all study participants who receive investigational product, number and percentage of participants with AESI for the duration of the study. Note: All participants will be followed for a minimum duration of 6 months following investigational product administration. |
| Number of Participants with Medically Attended Adverse Events | Through end of study follow-up, up to 1095 days postvaccination | Medically attended adverse events (MAAEs) are defined as adverse events requiring a visit to the hospital, emergency room, urgent care clinic, or other visits to or from medical personnel that are not part of routine scheduled study visits. For study participants in the Safety Subset, the number and percentage of participants with MAAEs for the duration of the study. Note: All participants will be followed for a minimum duration of 6 months following investigational product administration. |
| Anti-CHIKV Serum Neutralizing antibody titers | 3 weeks postvaccination | Geometric Mean Titers (GMTs) of anti-CHIKV serum neutralizing antibodies based on a validated luciferase based anti-CHIKV neutralization assay. |
| Anti-CHIKV Serum Neutralizing Antibody seroresponse rate | 3 weeks postvaccination | Seroresponse is defined as the presence of anti-CHIKV serum neutralizing antibody (SNA) titer meeting or exceeding 100. Seroresponse rate is defined as the percentage of participants with an Anti-CHIKV SNA titer meeting or exceeding a titer of 100 based on a validated luciferase based anti-CHIKV neutralization assay. |
Countries
Philippines, Thailand
Contacts
CONTACTAnjali Chudasama, MPH M.Sc.
CONTACTTiffany Brockington
STUDY_DIRECTORPatrick Ajiboye, MD
Bavarian Nordic A/S
Outcome results
None listed