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A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine (CHIKV VLP)

Primary Purpose

Chikungunya Virus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CHIKV VLP, adjuvanted
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chikungunya Virus

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Able and willing to provide informed consent voluntarily signed by subject.
  2. Any gender, 18 to 45 years of age (inclusive).
  3. Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, and screening laboratory assessments.
  4. Women who are either:

    (i). Not of childbearing potential (CBP): pre-menarche, anatomically sterile, or post-menopausal (defined as ≥12 months without menses) or (ii). Meeting all the following criteria: Negative urine pregnancy test at screening visit; and Negative urine pregnancy test immediately prior to dosing at Day 1; and using an acceptable method of contraception (if female of childbearing potential) for the duration of participation, such as: Hormonal contraceptives (e.g., implants, pills, patches) initiated ≥ 30 days prior to dosing or; Intrauterine device (IUD) inserted ≥30 days prior to dosing or; double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap).

Exclusion Criteria:

  1. Currently pregnant, breastfeeding, or planning to become pregnant during the study.
  2. Body Mass Index (BMI) ≥35 kg/m2.
  3. Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).
  4. History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP).
  5. History of known congenital or acquired immunodeficiency that could impact response to vaccination (e.g., leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis).
  6. Prior or anticipated receipt of immunomodulatory or immunosuppressive therapy from six months prior to screening through Day 64.
  7. Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 64.
  8. Acute disease within the last 14 days (subjects 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).
  9. Clinically significant cardiac, pulmonary, respiratory, rheumatologic, or other chronic disease, in the opinion of the Investigator. This may include chronic illness requiring hospitalization in the last one month prior to screening.
  10. Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation.
  11. Receipt or anticipated receipt of any vaccine from 30 days prior to screening through Day 64.
  12. Prior receipt of an investigational CHIKV vaccine/product.
  13. Detectable baseline anti-CHIKV IgG antibody as determined by ELISA.
  14. Any other condition that, in the opinion of the Investigator, could adversely impact the subject's participation or the conduct of the study, creates an unacceptable risk to the subject, or may interfere with the conduct of the study or validity of the data.
  15. Restricted venous access that would prevent the collection of plasma and serum necessary for participation.
  16. Weight <110 pounds.

Sites / Locations

  • Johnson County ClinTrials

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PXVX0317 (CHIKV VLP, alum-adjuvanted) vaccine

Arm Description

All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).

Outcomes

Primary Outcome Measures

CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22
CHIKV SNA Seroresponse Rate (Titer >=40) and Associated 95% Confidence Interval (CI) at Day 22
CHIKV SNA GMT (Geometric Mean Titer) at Day 22
CHIKV SNA GMT and Associated 95% CI at Day 22
CHIKV SNA Seroresponse Rates at Days 8, 15, and 57
CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57
CHIKV SNA GMTs at Days 8, 15, and 57
CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Number and Percentage of Participants with a CHIKV SNA Titer ≥15, 40, 60, 80, 100, 160, 640, and 4-fold Rise Over Baseline Thresholds at Days 8, 15, 22, and 57

Secondary Outcome Measures

Incidence of Solicited Adverse Events (AE) Through Day 8
Incidence of Solicited AEs Through Day 8
Incidence of Unsolicited AEs Through Day 29
Incidence of Unsolicited AEs Through Day 29
Incidence of Adverse Events of Special Interest (AESI) Through Day 183
Incidence of AESIs Through Day 183
Incidence of Serious Adverse Events (SAEs) Through Day 183
Incidence of SAEs Through Day 183

Full Information

First Posted
September 23, 2021
Last Updated
June 29, 2023
Sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions
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1. Study Identification

Unique Protocol Identification Number
NCT05065983
Brief Title
A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine
Acronym
CHIKV VLP
Official Title
A Phase 2 Open-Label Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], Aluminum Hydroxide Adjuvanted)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
May 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to assess the safety and immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], aluminum hydroxide adjuvanted).
Detailed Description
Primary Objectives: To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 (40 µg CHIKV VLP, alum-adjuvanted) as measured 21 days (Day 22) after vaccination. To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 as measured 7 days (Day 8), 14 days (Day 15), and 56 days (Day 57) after vaccination. Secondary Objectives: 1. To assess safety of a single adjuvanted dose of PXVX0317 in healthy adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open Label Safety and Immunogenicity
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PXVX0317 (CHIKV VLP, alum-adjuvanted) vaccine
Arm Type
Experimental
Arm Description
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
Intervention Type
Biological
Intervention Name(s)
CHIKV VLP, adjuvanted
Intervention Description
Adjuvanted formulation includes aluminum hydroxide
Primary Outcome Measure Information:
Title
CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22
Description
CHIKV SNA Seroresponse Rate (Titer >=40) and Associated 95% Confidence Interval (CI) at Day 22
Time Frame
21 days post vaccination
Title
CHIKV SNA GMT (Geometric Mean Titer) at Day 22
Description
CHIKV SNA GMT and Associated 95% CI at Day 22
Time Frame
21 days post vaccination
Title
CHIKV SNA Seroresponse Rates at Days 8, 15, and 57
Description
CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57
Time Frame
56 days post vaccination
Title
CHIKV SNA GMTs at Days 8, 15, and 57
Description
CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57
Time Frame
56 days post vaccination
Title
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
Description
CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
Time Frame
56 days post vaccination
Title
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
Description
CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
Time Frame
56 days post vaccination
Title
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
Description
GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57
Time Frame
56 days post vaccination
Title
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
Description
GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57
Time Frame
56 days post vaccination
Title
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
Description
GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57
Time Frame
56 days post vaccination
Title
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Description
Number and Percentage of Participants with a CHIKV SNA Titer ≥15, 40, 60, 80, 100, 160, 640, and 4-fold Rise Over Baseline Thresholds at Days 8, 15, 22, and 57
Time Frame
56 days post vaccination
Secondary Outcome Measure Information:
Title
Incidence of Solicited Adverse Events (AE) Through Day 8
Description
Incidence of Solicited AEs Through Day 8
Time Frame
7 days post vaccination
Title
Incidence of Unsolicited AEs Through Day 29
Description
Incidence of Unsolicited AEs Through Day 29
Time Frame
28 days post vaccination
Title
Incidence of Adverse Events of Special Interest (AESI) Through Day 183
Description
Incidence of AESIs Through Day 183
Time Frame
182 days post vaccination
Title
Incidence of Serious Adverse Events (SAEs) Through Day 183
Description
Incidence of SAEs Through Day 183
Time Frame
182 days post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able and willing to provide informed consent voluntarily signed by participant. Any gender, 18 to 45 years of age (inclusive). 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, anatomically sterile, or post-menopausal (defined as ≥12 months without menses) or (ii). Meeting all the following criteria: Negative urine pregnancy test at screening visit; and Negative urine pregnancy test immediately prior to dosing at Day 1; and using an acceptable method of contraception (if female of childbearing potential) for the duration of participation, such as: Hormonal contraceptives (e.g., implants, pills, patches) initiated ≥ 30 days prior to dosing or; Intrauterine device (IUD) inserted ≥30 days prior to dosing or; double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap). 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 investigational product (IP). History of known congenital or acquired immunodeficiency that could impact response to vaccination (e.g., leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Prior or anticipated receipt of immunomodulatory or immunosuppressive therapy from six months prior to screening through Day 64. Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 64. 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, respiratory, rheumatologic, or other chronic disease, in the opinion of the Investigator. This may include chronic illness requiring hospitalization in the last one month 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 screening through Day 64. Prior receipt of an investigational CHIKV vaccine/product. Detectable baseline anti-CHIKV IgG antibody as determined by ELISA. Any other condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study, creates an unacceptable risk to the participant, or may interfere with the conduct of the study or validity of the data. Restricted venous access that would prevent the collection of plasma and serum necessary for participation. Weight <110 pounds.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Ajiboye
Organizational Affiliation
Emergent BioSolutions
Official's Role
Study Director
Facility Information:
Facility Name
Johnson County ClinTrials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine

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