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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05349617
Recruitment Status : Not yet recruiting
First Posted : April 27, 2022
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
Catalyst Clinical Research
Information provided by (Responsible Party):
Emergent BioSolutions

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.

Condition or disease Intervention/treatment Phase
Chikungunya Virus Biological: CHIKV VLP/adjuvant Biological: Placebo Phase 3

Detailed Description:

Primary objectives:

  • To compare the anti-chikungunya virus (CHIKV) serum neutralizing antibodies (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 Days 15 and 183 as measured by difference in seroresponse rate (PXVX0317 minus placebo) and GMT in adults ≥65 years of age.
  • To evaluate the anti-CHIKV SNA response to PXVX0317 in adults ≥65 years of age at Day 15, Day 22, and Day 183.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 - PXVX0317 Biological: CHIKV VLP/adjuvant
PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on Alhydrogel adjuvant 2%

Placebo Comparator: Group 2 - Placebo Biological: Placebo
Placebo is comprised of formulation buffer




Primary Outcome Measures :
  1. Anti-CHIKV SNA seroresponse rates at Day 22 in baseline seronegative participants [ Time Frame: 22 days ]
    The difference in anti-CHIKV SNA seroresponse rate between PXVX0317 and placebo, and corresponding two-sided 95% confidence interval (CI), at Day 22 among baseline seronegative participants

  2. Anti-CHIKV SNA seroresponse rates at Day 22 [ Time Frame: 22 days ]
    Anti-CHIKV SNA seroresponse rates and associated two-sided 95% CIs at Day 22 for PXVX0317 and placebo groups and treatment group comparison

  3. Anti-CHIKV SNA GMTs at Day 22 [ Time Frame: 22 days ]
    Anti-CHIKV SNA GMTs and associated two-sided 95% CIs at Day 22 for PXVX0317 and placebo groups and treatment group comparison

  4. Incidence of solicited adverse events (AE) [ Time Frame: 8 days ]
    Incidence of solicited AEs through Day 8

  5. Incidence of unsolicited AEs [ Time Frame: 29 days ]
    Incidence of unsolicited AEs through Day 29

  6. Incidence of Serious Adverse Events (SAE) [ Time Frame: 183 days ]
    Incidence of SAEs through Day 183

  7. Incidence of Medically Attended Adverse Events (MAAE) [ Time Frame: 183 days ]
    Incidence of MAAEs through Day 183

  8. Incidence of Adverse Events of Special Interest (AESI) [ Time Frame: 183 days ]
    Incidence of AESI through Day 183


Secondary Outcome Measures :
  1. Anti-CHIKV SNA seroresponse rates at Days 15 and 183 [ Time Frame: 183 days ]
    Anti-CHIKV SNA seroresponse rates and associated two-sided 95% CIs at Day 15 and Day 183 for PXVX0317 and placebo groups and treatment group comparisons

  2. Anti-CHIKV SNA GMTs at Days 15 and 183 [ Time Frame: 183 days ]
    Anti-CHIKV SNA GMTs and associated two-sided 95% CIs at Day 15 and Day 183 for PXVX0317 and placebo groups and treatment group comparison

  3. Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI) [ Time Frame: 183 days ]
    Anti-CHIKV SNA GMFI from Day 1 to Day 15, Day 22, and Day 183 for PXVX0317 and placebo groups

  4. Subjects with anti-CHIKV SNA titers of at least 4-fold rise over baseline [ Time Frame: 183 days ]
    Number and percentage of subjects with anti-CHIKV SNA titers of at least 4-fold rise over baseline at Days 15, 22, and 183 for PXVX0317 and placebo groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 post-menopausal (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 (e.g., 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 (e.g., 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 (e.g., 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 (i.e., 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05349617


Contacts
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Contact: Patrick Ajiboye, MD 2408411378 ajiboyep@ebsi.com

Locations
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United States, Florida
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Contact: Robert Perry    305-698-4500    rperry@panaxcr.com   
Suncoast Research Associates, LLC
Miami, Florida, United States, 33173
Contact: Jorge Caso    786-623-3135    jcasomd@sratrials.com   
Global Clinical Research Professionals (GCP)
Saint Petersburg, Florida, United States, 33705
Contact: Lawrence Galitz    727-520-1427    lgalitz@researchgcp.com   
United States, Missouri
AMR Kansas City
Kansas City, Missouri, United States, 64114
Contact: Gregory Appenfeller    816-943-0770    gregory.appenfeller@amrllc.com   
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
Contact: Matthew Davis    585-288-0890    MDavis@rcrclinical.com   
United States, South Carolina
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Contact: Cayce Tangeman    843-352-6977    ctangeman@coastalcarolinaresearch.com   
United States, Texas
DM Clinical Research CyFair
Houston, Texas, United States, 77065
Contact: Muhammad Irfan    281-517-0550    drirfan@dmclinicalresearch.com   
BHFC Research
San Antonio, Texas, United States, 78249
Contact: Ramon Reyes    210-296-2445    drreYes@dmclinicalresearch.com   
DM Clinical Research Tomball
Tomball, Texas, United States, 77375
Contact: Vicki Miller    281-517-0550    vicki.miller@tcddresearch.com   
United States, Wisconsin
Spaulding Clinical
West Bend, Wisconsin, United States, 53095
Contact: Jennifer Boston    262-334-6020    jennifer.boston@spauldingclinical.com   
Sponsors and Collaborators
Emergent BioSolutions
Catalyst Clinical Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT05349617    
Other Study ID Numbers: EBSI-CV-317-005
First Posted: April 27, 2022    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emergent BioSolutions:
chikungunya
virus like particle (VLP)
PXVX0317
vaccine
immunogenicity
Additional relevant MeSH terms:
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Chikungunya Fever
Alphavirus Infections
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
Togaviridae Infections
RNA Virus Infections