A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine)

Phase 3CompletedNCT05072080

Bavarian Nordic3,258 enrolled

Overview

The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent subjects.

Coprimary Objectives: 1. To evaluate the safety of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent participants 12 to \<65 years of age. 2. To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo). 3. To demonstrate the consistency of the anti-CHIKV SNA response across three consecutively manufactured lots of PXVX0317 (CHIKV VLP vaccine) at Day 22 as measured by GMT. Secondary Objectives: 1. To compare the anti-CHIKV SNA response to PXVX0317 (CHIKV VLP vaccine) and placebo at Day 15, Day 183, and Day 8 as measured by GMT and seroresponse rate. 2. To compare the GMT fold increase in anti-CHIKV SNA response and number and percentage of participants with an anti-CHIKV SNA titer ≥15 and 4-fold rise over baseline, both at Day 8, 15, 22, and 183.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

3,258

Conditions

Chikungunya Virus

Interventions

CHIKV VLP/adjuvantBIOLOGICAL

CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%

PlaceboBIOLOGICAL

Placebo is comprised of formulation buffer

Eligibility

Sex: ALLMin age: 12 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). * Males or females, 12 to \<65 years of age. * Generally healthy, in the opinion of the investigator, based on medical history, physical examination, and screening laboratory assessments. * Women who are either: (i) Not of childbearing potential (CBP): pre-menarche, 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 sex-hormonal treatment) or (ii) Meeting all the below criteria: Negative serum pregnancy test at screening visit, Negative urine pregnancy test immediately prior to dosing at Day 1, Using an acceptable method of contraception (if women of CBP) for the duration of participation, such as hormonal contraceptives (eg, implants, pills, patches) initiated ≥30 days prior to dosing, intrauterine device (IUD) inserted ≥30 days prior to dosing, double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap), Abstinence is acceptable only for adolescents (12 to \<18 years old) who are not sexually active. Exclusion Criteria: * Currently pregnant, breastfeeding, or planning to become pregnant during the study. * Body Mass Index (BMI) ≥35 kg/m2. * Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV). * History of severe allergic reaction or anaphylaxis to any component of the vaccine. * 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). * 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. * Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22. * 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). * 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. * Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation. * Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22. * Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study. * Prior receipt of an investigational CHIKV vaccine/product. * Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.

Locations (47)

Outcomes

Primary Outcomes

Incidence of Solicited Adverse Events (AE)

Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

Time frame: 7 days post-vaccination

Incidence of Unsolicited AEs

Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

Time frame: 28 days post-vaccination

Incidence of Adverse Events of Special Interest (AESI)

Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

Time frame: 182 days post-vaccination

Incidence of Medically Attended Adverse Event (MAAE)

Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

Time frame: 182 days post-vaccination

Incidence of Serious Adverse Event (SAE)

Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

Time frame: 182 days post-vaccination

Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22

Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) 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.

Time frame: 21 days post-vaccination

Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22 (Data Reported Per Arm)

Data from ClinicalTrials.gov

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Optimal Research, LLC

Huntsville, Alabama, United States

Alliance for Multispecialty Research - Mobile

Mobile, Alabama, United States

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Tempe, Arizona, United States

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Banning, California, United States

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San Diego, California, United States

Lynn Institute of the Rockies

Colorado Springs, Colorado, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Accel Research Sites-DeLand Clinical Research Unit

Lake Mary, Florida, United States

Optimal Research, LLC

Melbourne, Florida, United States

Suncoast Research Associates, LLC

Miami, Florida, United States

...and 37 more locations

Secondary Outcomes

Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8

Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) 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. Number analyzed is number of participants with a sample result available at the indicated visit.

Time frame: Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)

Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8 (Data Reported Per Arm)

Anti-CHIKV SNA seroresponse rates and associated 95% CIs for PXVX0317 (CHIKV VLP vaccine) and placebo at Day 15, Day 183, and Day 8, in that order, for the IEP, all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit.

Time frame: Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)

Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183

Anti-CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit.

Time frame: Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)

Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 (Data Reported Per Arm)

Time frame: Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)

Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183

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. Fold rise in geometric mean titer is the ratio of the post-baseline value to the baseline value (e.g. number of 2 represents a post-baseline doubling of geometric mean titer). Number analyzed is number of participants with a sample result available at both Day 1 and the indicated visit.

Time frame: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)

Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183 (Data Reported Per Arm)

Time frame: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)

Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183

Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit.

Time frame: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)

Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)

Time frame: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)