Healthy Volunteers (Chikungunya disease. Prevention of Chikungunya disease by use of a vaccine) MedDRA version: 20.1 Level: PT Classification code 10067256 Term: Chikungunya virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
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). 2. Males or females, 12 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 vaccine. 5. History of any known congenital or acquired immunodeficiency that could impact response to vaccination (eg, leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis). 6. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to screening through Day 22. Note: For systemic corticosteroids, use at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within three months of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, ocular, or intraocular steroids is allowed. 7. Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22. 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, rheumatologic, or other chronic disease, in the opinion of the investigator. This may include chronic illness requiring hospitalization in the last 30 days 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 Day 1 through Day 22. 12. Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study. 13. Prior receipt of an investigational CHIKV vaccine/product. 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: Coprimary Objectives: 1. To evaluate the safety of PXVX0317 in healthy adult and adolescent participants 12 to =15 and 4-fold rise over baseline, both at Day 8, 15, 22, and 183.;Primary end point(s): 1. Incidence of solicited AEs through Day 8 for PXVX0317 and placebo for all age strata combined (safety population). 2. Incidence of unsolicited AEs through Day 29 for PXVX0317 and placebo for all age strata combined (safety population). 3. Incidence of AESIs, through Day 183 for PXVX0317 and placebo for all age strata combined (safety population). 4. Incidence of MAAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population). 5. Incidence of SAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population). 6. Anti-CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% confidence interval (CI) at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined. 7. Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 and placebo for the IEP, all age strata combined. 8. Anti-CHIKV SNA GMT ratios and associated 95% CIs between all three pairs of PXVX0317 lots (A:B, A:C, B:C) in adults 18 to <46 years of age in the IEP at Day 22.;Timepoint(s) of evaluation of this end point: Days 8, 22, 29, and 183 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Anti-CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% CIs at Day 15, Day 183, and Day 8, in that order, for the IEP, all age strata combined. 2. Anti-CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 and placebo for the IEP, all age strata combined. 3. Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined. 4. Number and percentage of participants with anti-CHIKV SNA titers =15 at Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined. 5. Number and percentage of participants with anti-CHIKV SNA titers having a 4-fold rise over baseline at Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined. ;Timepoint(s) of evaluation of this end point: Days 8, 15, 22, and 183 | — |
Countries
United States
Contacts
Public ContactMedical Information
Bavarian Nordic
Outcome results
None listed