Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years

Chikungunya Virus Clinical Trial

Official title:

A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349617
• Other study ID #: EBSI-CV-317-005
• Status: Completed
• Phase: Phase 3
• Start date: May 12, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: June 2024
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: August 8, 2023
• Est. primary completion date: June 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chikungunya Fever
• Chikungunya Virus

Intervention

Biological:
• CHIKV VLP/adjuvant
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
• Placebo
Placebo is comprised of formulation buffer

Locations

Country	Name	City	State
United States	DM Clinical Research CyFair	Houston	Texas
United States	AMR Kansas City	Kansas City	Missouri
United States	Suncoast Research Associates, LLC	Miami	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Global Clinical Research Professionals (GCP)	Saint Petersburg	Florida
United States	BHFC Research	San Antonio	Texas
United States	DM Clinical Research Tomball	Tomball	Texas
United States	Spaulding Clinical	West Bend	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Bavarian Nordic	Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-CHIKV SNA seroresponse rates at Day 22 in baseline seronegative participants	Difference in anti-CHIKV SNA seroresponse rate (PXVX0317 minus placebo) and associated 95% confidence interval (CI) at Day 22.	21 days post vaccination
Primary	Anti-CHIKV SNA GMTs at Day 22	Anti-CHIKV SNA GMT and associated 95% CIs at Day 22 for PXVX0317 and placebo.	21 days post vaccination
Primary	Incidence of solicited adverse events (AE)	Incidence of solicited AEs through Day 8	7 days post vaccination
Primary	Incidence of unsolicited AEs	Incidence of unsolicited AEs through Day 29	28 days post vaccination
Primary	Incidence of Serious Adverse Events (SAE)	Incidence of SAEs through Day 183	182 days post vaccination
Primary	Incidence of Medically Attended Adverse Events (MAAE)	Incidence of MAAEs through Day 183	182 days post vaccination
Primary	Incidence of Adverse Events of Special Interest (AESI)	Incidence of AESI through Day 183	182 days post vaccination
Secondary	Anti-CHIKV SNA seroresponse rates at Days 15 and 183	Difference in anti-CHIKV SNA seroresponse rate (PXVX0317 minus placebo) with associated 95% CIs at Day 15 and Day 183.	182 days post vaccination
Secondary	Anti-CHIKV SNA GMTs at Days 15 and 183	Anti-CHIKV SNA GMTs by study arm with associated 95% CIs at Day 15 and Day 183.	182 days post vaccination
Secondary	Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)	Geometric mean fold increase (GMFI) from Day 1 to subsequent collection time points.	182 days post vaccination
Secondary	Subjects with anti-CHIKV SNA titer =15 and 4-fold rise over baseline	Number and percentage of participants with an anti-CHIKV SNA titer =15 and 4-fold rise over baseline.	182 days post vaccination