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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05072080
Recruitment Status : Active, not recruiting
First Posted : October 8, 2021
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Brief 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.

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

Detailed Description:

Primary Objectives:

  1. To evaluate the safety of PXVX0317 in healthy adult and adolescent subjects 12 to <65 years of age.
  2. To compare the chikungunya virus (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 8, Day 15, and Day 183.
  2. To compare the anti-CHIKV SNA response to PXVX0317 and placebo in subjects 12 to <18 years of age, subjects 18 to <46 years of age, and subjects 46 to <65 years of age.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized in a 2:2:2:1 ratio within each age stratum (12 to <18, 18 to <46, and 46 to <65). This study will be conducted in the US, using up to 50 sites.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents
Actual Study Start Date : September 29, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya Vaccines

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

Experimental: Group 2
Group 2 - PXVX0317 lot B
Biological: CHIKV VLP/adjuvant
PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on Alhydrogel® adjuvant 2%

Experimental: Group 3
Group 3 - PXVX0317 lot C
Biological: CHIKV VLP/adjuvant
PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on Alhydrogel® adjuvant 2%

Placebo Comparator: Group 4
Group 4 - Placebo
Biological: Placebo
Placebo is comprised of formulation buffer




Primary Outcome Measures :
  1. Incidence of solicited Adverse Events (AE) [ Time Frame: 8 days ]
    Incidence of solicited AEs through Day 8 for PXVX0317 and placebo for all age strata combined (safety population).

  2. Incidence of unsolicited AEs [ Time Frame: 29 days ]
    Incidence of unsolicited AEs through Day 29 for PXVX0317 and placebo for all age strata combined (safety population).

  3. Incidence of Adverse Events of Special Interest (AESI) [ Time Frame: 183 days ]
    Incidence of AESIs, through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).

  4. Incidence of Medically Attended Adverse Event (MAAE) [ Time Frame: 183 days ]
    Incidence of MAAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).

  5. Incidence of Serious Adverse Event (SAE) [ Time Frame: 183 days ]
    Incidence of SAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).

  6. CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 22 [ Time Frame: 22 days ]
    CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% confidence interval (CI) at Day 22 for the IEP population, all age strata combined.

  7. CHIKV SNA geometric mean titers (GMT) at Day 22 [ Time Frame: 22 days ]
    CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 and placebo for the IEP population, all age strata combined.

  8. CHIKV SNA GMT ratios between pairs of PXVX0317 lots at Day 22 [ Time Frame: 22 days ]
    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 population at Day 22.


Secondary Outcome Measures :
  1. CHIKV SNA seroresponse rates at Days 8, 15, and 183 [ Time Frame: 183 days ]
    CHIKV SNA seroresponse rates for PXVX0317 and placebo, difference (PXVX0317 minus placebo), and associated 95% CIs at Day 8, Day 15, and Day 183 for the IEP population, all age strata combined.

  2. CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 [ Time Frame: 183 days ]
    CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 and placebo for the IEP population, all age strata combined.

  3. Geometric Mean Fold Increase (GMFI) in CHIKV SNA titers from Day 1 to Days 8, 15, 22, and 183 [ Time Frame: 183 days ]
    Geometric mean fold increase (GMFI) in CHIKV SNA titers from Day 1 to Day 8, Day 15, Day 22, and Day 183 for the IEP population for all age strata combined.

  4. Number and percentage of subjects with CHIKV SNA titers at or above selected thresholds at Days 8, 15, 22, and 183 [ Time Frame: 183 days ]
    Number and percentage of subjects with CHIKV SNA titers ≥15, 60, 100, 160, 640, and 4-fold rise over baseline thresholds at Day 8, Day 15, Day 22, and Day 183 for the IEP population for all age strata combined.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by subject (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 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 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 (e.g., 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-<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 (e.g., 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 (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).
  • 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 subject'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 subject's participation or the 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): NCT05072080


Locations
Show Show 47 study locations
Sponsors and Collaborators
Emergent BioSolutions
Investigators
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Study Director: Patrick Ajiboye, MD Emergent BioSolutions
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT05072080    
Other Study ID Numbers: EBSI-CV-317-004
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
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