Clinical trial NCT05349617: Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years
Official title: A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chikungunya Virus
Keywords: chikungunya
virus like particle (VLP)
PXVX0317
vaccine
immunogenicity
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: Emergent BioSolutions
First posted: 2022-04-27
Enrollment: 413
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Co-primary Objectives:

* To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo) in adults ≥65 years of age.
* To evaluate the safety of PXVX0317 in adults ≥65 years of age

Secondary Objectives:

* To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15 and Day 183, as measured by GMT and seroresponse rate.
* To compare the anti-CHIKV SNA response to PXVX0317 and placebo in participants ≥65 to \<75 and ≥75 years of age as measured by GMT and seroresponse rate.

Eligibility criteria: Inclusion Criteria:

* Able and willing to provide informed consent voluntarily signed by participant. Must verbalize understanding of the general procedures of, and reason for the study.
* Males or females, ≥65 years of age.
* Able to complete all scheduled visits and comply with all study procedures.
* Women who are not of childbearing potential (CBP): surgically sterile (at least six weeks post bilateral tubal ligation, 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 post menopausal sex-hormonal treatment).
* Participants must be in stable health in the opinion of the investigator for at least 30 days prior to screening (eg, no hospital admission for acute illness in the last 30 days prior to screening).

Exclusion Criteria:

* Participation or planned participation in an investigational clinical trial (eg, vaccine, drug, medical device, or medical procedure) within 30 days of Day 1 and for the duration of the study. Note: Participation in an observational trial or follow-up phase of a trial may be allowed; however, these instances should be discussed with the sponsor's medical monitor (MM) prior to enrollment.
* Prior receipt of any CHIKV vaccine.
* Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
* Body mass index (BMI) ≥35 kg/m\^2
* History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product (IP).
* History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination (eg, leukemia, lymphoma, malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Note: History of basal cell and squamous cell carcinoma of the skin or carcinoma in situ of the cervix considered cured would not be exclusionary. History of a malignancy considered cured from over five years from the date of screening with minimal risk of recurrence is not exclusionary.
* Prior or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to screening through Day 22. Note: Systemic corticosteroid use 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 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed.
* Bleeding disorder or receipt of anticoagulants in the 21 days prior to screening, contraindicating intramuscular (IM) vaccination, as judged by the investigator.
* Moderate or severe acute illness with or without fever (oral temperature ≥100.4°F or 38.0°C).
* Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through Day 22.
* Medical condition (such as dementia) that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.
* Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.
* 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.
* Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22.
* Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22.
* Any planned elective surgery that may interfere with study participation or conduct.
* Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.

Primary outcomes:
measure: Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants
timeFrame: 21 days postvaccination
measure: Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22
timeFrame: 21 days postvaccination
measure: Incidence of Solicited Adverse Events (AE)
timeFrame: 7 days postvaccination
measure: Incidence of Unsolicited AEs
timeFrame: 28 days postvaccination
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: 182 days postvaccination
measure: Incidence of Medically Attended Adverse Events (MAAE)
timeFrame: 182 days postvaccination
measure: Incidence of Adverse Events of Special Interest (AESI)
timeFrame: 182 days postvaccination
Secondary outcomes:
measure: Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183
timeFrame: Day 15 and 183 (14 and 182 days postvaccination, respectively)
measure: Anti-CHIKV SNA GMTs at Days 15 and 183
timeFrame: Day 15, and 183 (14 and 182 days postvaccination, respectively)
measure: Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)
timeFrame: Day 15, 22, and 183 (14, 21 and 182 days postvaccination, respectively)
measure: Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
timeFrame: Day 15, 22 and 183 (14, 21 and 182 days postvaccination, respectively)
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Global Clinical Research Professionals (GCP)
state: Florida
city: Kansas City
country: United States
facility: AMR Kansas City
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Houston
country: United States
facility: DM Clinical Research CyFair
state: Texas
city: San Antonio
country: United States
facility: BHFC Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research Tomball
state: Texas
city: West Bend
country: United States
facility: Spaulding Clinical
state: Wisconsin
Study officials:
affiliation: Bavarian Nordic
name: Patrick Ajiboye, MD
role: STUDY_DIRECTOR
References:
citation: 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.