Chikungunya virus infection MedDRA version: 20.1 Level: PT Classification code 10067256 Term: Chikungunya virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: VIMKUNYA
Product Name: CHIKV VLP
Product Code: CHIKV VLP
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of
Sponsors
Bavarian Nordic A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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: a. 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 b. 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. Are the trial subjects under 18? yes Number of subjects for this age range: 308 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5530 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 308
Exclusion criteria
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 °C [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 |
|---|---|
| Main Objective: 1. To evaluate the safety, immunogenicity, and efficacy of CHIKV VLP vaccine versus placebo in nonpregnant participants aged 12 and older at risk of CHIKV infection. ;Secondary Objective: 1. To evaluate the vaccine efficacy of CHIKV VLP in the prevention of chronic CHIKV disease. 2. To evaluate the CHIKV VLP vaccine for prevention of severe CHIKV disease. 3. To evaluate the immunogenicity of CHIKV VLP vaccine.;Primary end point(s): 1. Incidence of laboratory-confirmed acute CHIKV disease: 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. ;Timepoint(s) of evaluation of this end point: 1. From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of laboratory-confirmed chronic CHIKV disease: 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. 2. Incidence of laboratory-confirmed severe CHIKV disease: 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. 3. Number of participants with Solicited or Local Adverse Events: In the Safety Subset, the number and percentage of participants with local and systemic reactogenicity events through 7 days postvaccination. 4. Number of participants with Unsolicited Adverse Events: In the Safety Subset, the number and percentage of participants with unsolicited adverse events through 28 days postvaccination. 5. Number of Participants with Serious Adverse Events: 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. 6. Number of Participants with Adverse Events of Special Interest: 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. 7. Number of Participants with Medically Attended Adverse Events: Medically attended adverse events (MAAEs) are defined as adverse events requiring a visit to the hos | — |
Countries
Philippines, Thailand
Contacts
Public ContactMedical Information
Bavarian Nordic A/S
Outcome results
None listed