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

Chikungunya Virus Clinical Trial

Official title:

A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072080
• Other study ID #: EBSI-CV-317-004
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2021
• Est. completion date: April 3, 2023

Study information

• Verified date: December 2023
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Coprimary Objectives:

1. To evaluate the safety of PXVX0317 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 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate.

3. To demonstrate the consistency of the anti-CHIKV SNA response across three lots of PXVX0317 at Day 22.

Secondary Objectives:

1. To compare the anti-CHIKV SNA response to PXVX0317 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3258
• Est. completion date: April 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chikungunya Fever
• Chikungunya Virus

Intervention

Biological:
• CHIKV VLP/adjuvant
PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
• Placebo
Placebo is comprised of formulation buffer

Locations

Country	Name	City	State
United States	Synexus Clinical Research US, Inc.	Anderson	South Carolina
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Velocity Clinical Research, Banning	Banning	California
United States	Velocity Clinical Research, Austin	Cedar Park	Texas
United States	Synexus Clinical Research US, Inc.	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center	Cincinnati	Ohio
United States	Velocity Clinical Rsearch, Inc.	Cleveland	Ohio
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Aventiv Research Inc.	Columbus	Ohio
United States	Velocity Clinical Research-Providence	East Greenwich	Rhode Island
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Optimal Research, LLC	Huntsville	Alabama
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Alliance for Multispecialty Research - Kansas City	Kansas City	Missouri
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Accel Research Sites-DeLand Clinical Research Unit	Lake Mary	Florida
United States	Alliance for Multispecialty Research, LLC.	Las Vegas	Nevada
United States	Wr-Crcn, Llc	Las Vegas	Nevada
United States	Johnson County ClinTrials	Lenexa	Kansas
United States	Alliance for Multispecialty Research, LLC	Lexington	Kentucky
United States	Velocity Clinical Research, Medford	Medford	Oregon
United States	Optimal Research, LLC	Melbourne	Florida
United States	Velocity Clinical Research, Boise	Meridian	Idaho
United States	Suncoast Research Associates, LLC	Miami	Florida
United States	Alliance for Multispecialty Research - Mobile	Mobile	Alabama
United States	Alliance for Multispecialty Research, LLC	New Orleans	Louisiana
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Alliance for Multispecialty Research, LLC	Norfolk	Virginia
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Optimal Research LLC	Peoria	Illinois
United States	Synexus Clinical Research US, Inc.	Pinellas Park	Florida
United States	Research Your Health	Plano	Texas
United States	M3 Wake Research, Inc	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Optimal Research, LLC	Rockville	Maryland
United States	Saint Louis University	Saint Louis	Missouri
United States	Synexus Clinical Research US, Inc.	Saint Louis	Missouri
United States	BFHC Research	San Antonio	Texas
United States	Optimal Research, LLC	San Diego	California
United States	Alliance for Multispecialty Research, LLC	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Advanced Clinical Research	West Jordan	Utah
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Alliance for Multispecialty Research - Wichita East	Wichita	Kansas
United States	Trial Management Associates, LLC	Wilmington	North Carolina

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	Incidence of solicited Adverse Events (AE)	Incidence of solicited AEs through Day 8 for PXVX0317 and placebo for all age strata combined (safety population).	8 days
Primary	Incidence of unsolicited AEs	Incidence of unsolicited AEs through Day 29 for PXVX0317 and placebo for all age strata combined (safety population).	29 days
Primary	Incidence of Adverse Events of Special Interest (AESI)	Incidence of AESIs, through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).	183 days
Primary	Incidence of Medically Attended Adverse Event (MAAE)	Incidence of MAAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).	183 days
Primary	Incidence of Serious Adverse Event (SAE)	Incidence of SAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).	183 days
Primary	Anti-CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 22	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.	22 days
Primary	Anti-CHIKV SNA geometric mean titers (GMT) at Day 22	Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 and placebo for the IEP, all age strata combined.	22 days
Primary	Anti-CHIKV SNA GMT ratios between pairs of PXVX0317 lots at Day 22	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.	22 days
Secondary	Anti-CHIKV SNA seroresponse rates at Days 15, 183, and 8	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.	183 days
Secondary	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 and placebo for the IEP, all age strata combined.	183 days
Secondary	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.	183 days
Secondary	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.	183 days