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

Primary Purpose

Chikungunya Virus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CHIKV VLP/adjuvant
Placebo
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chikungunya Virus focused on measuring Chikungunya, VLP, PXVX0317, vaccine, immunogenicity

Eligibility Criteria

12 Years - 64 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Optimal Research, LLC
  • Alliance for Multispecialty Research - Mobile
  • Alliance for Multispecialty Research, LLC
  • Velocity Clinical Research, Banning
  • Optimal Research, LLC
  • Lynn Institute of the Rockies
  • Jacksonville Center for Clinical Research
  • Accel Research Sites-DeLand Clinical Research Unit
  • Optimal Research, LLC
  • Suncoast Research Associates, LLC
  • Synexus Clinical Research US, Inc.
  • Palm Beach Research Center
  • Emory University School of Medicine
  • Velocity Clinical Research, Boise
  • Synexus Clinical Research US, Inc.
  • Optimal Research LLC
  • Johnson County ClinTrials
  • Alliance for Multispecialty Research, LLC
  • Alliance for Multispecialty Research - Wichita East
  • Alliance for Multispecialty Research, LLC
  • Alliance for Multispecialty Research, LLC
  • Optimal Research, LLC
  • Alliance for Multispecialty Research - Kansas City
  • Saint Louis University
  • Synexus Clinical Research US, Inc.
  • Wr-Crcn, Llc
  • Alliance for Multispecialty Research, LLC.
  • Rochester Clinical Research, Inc.
  • M3 Wake Research, Inc
  • Trial Management Associates, LLC
  • Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center
  • Velocity Clinical Rsearch, Inc.
  • Aventiv Research Inc.
  • Lynn Institute of Norman
  • Lynn Health Science Institute
  • Velocity Clinical Research, Medford
  • Velocity Clinical Research-Providence
  • Synexus Clinical Research US, Inc.
  • Coastal Carolina Research Center
  • Alliance for Multispecialty Research, LLC
  • Velocity Clinical Research, Austin
  • Texas Center for Drug Development, Inc.
  • Research Your Health
  • BFHC Research
  • DM Clinical Research
  • Advanced Clinical Research
  • Alliance for Multispecialty Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Group 1 - PXVX0317 lot A

Group 2 - PXVX0317 lot B

Group 3 - PXVX0317 lot C

Group 4 - Placebo

Outcomes

Primary Outcome Measures

Incidence of solicited Adverse Events (AE)
Incidence of solicited AEs through Day 8 for PXVX0317 and placebo for all age strata combined (safety population).
Incidence of unsolicited AEs
Incidence of unsolicited AEs through Day 29 for PXVX0317 and placebo for all age strata combined (safety population).
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).
Incidence of Medically Attended Adverse Event (MAAE)
Incidence of MAAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
Incidence of Serious Adverse Event (SAE)
Incidence of SAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 28, 2021
Last Updated
June 29, 2023
Sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions
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1. Study Identification

Unique Protocol Identification Number
NCT05072080
Brief Title
A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317
Official Title
A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP-Based Chikungunya Vaccine PXVX0317 in Healthy Adults and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
November 23, 2022 (Actual)
Study Completion Date
April 3, 2023 (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
Yes

5. Study Description

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.
Detailed Description
Coprimary Objectives: To evaluate the safety of PXVX0317 in healthy adult and adolescent participants 12 to <65 years of age. 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. To demonstrate the consistency of the anti-CHIKV SNA response across three lots of PXVX0317 at Day 22. Secondary Objectives: To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15, Day 183, and Day 8. To compare the anti-CHIKV SNA response to PXVX0317 and placebo in participants 12 to <18 years of age, participants 18 to <46 years of age, and participants 46 to <65 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Virus
Keywords
Chikungunya, VLP, PXVX0317, vaccine, immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants 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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1 - PXVX0317 lot A
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Group 2 - PXVX0317 lot B
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Group 3 - PXVX0317 lot C
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
Group 4 - Placebo
Intervention Type
Biological
Intervention Name(s)
CHIKV VLP/adjuvant
Intervention Description
PXVX0317 vaccine is comprised of chikungunya virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo is comprised of formulation buffer
Primary Outcome Measure Information:
Title
Incidence of solicited Adverse Events (AE)
Description
Incidence of solicited AEs through Day 8 for PXVX0317 and placebo for all age strata combined (safety population).
Time Frame
8 days
Title
Incidence of unsolicited AEs
Description
Incidence of unsolicited AEs through Day 29 for PXVX0317 and placebo for all age strata combined (safety population).
Time Frame
29 days
Title
Incidence of Adverse Events of Special Interest (AESI)
Description
Incidence of AESIs, through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
Time Frame
183 days
Title
Incidence of Medically Attended Adverse Event (MAAE)
Description
Incidence of MAAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
Time Frame
183 days
Title
Incidence of Serious Adverse Event (SAE)
Description
Incidence of SAEs through Day 183 for PXVX0317 and placebo for all age strata combined (safety population).
Time Frame
183 days
Title
Anti-CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 22
Description
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.
Time Frame
22 days
Title
Anti-CHIKV SNA geometric mean titers (GMT) at Day 22
Description
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 and placebo for the IEP, all age strata combined.
Time Frame
22 days
Title
Anti-CHIKV SNA GMT ratios between pairs of PXVX0317 lots at Day 22
Description
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.
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Anti-CHIKV SNA seroresponse rates at Days 15, 183, and 8
Description
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.
Time Frame
183 days
Title
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183
Description
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.
Time Frame
183 days
Title
Geometric Mean Fold Increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Days 8, 15, 22, and 183
Description
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.
Time Frame
183 days
Title
Number and percentage of participants with anti-CHIKV SNA titer >15 and 4-fold rise over baseline at Days 8, 15, 22, and 183
Description
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.
Time Frame
183 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Ajiboye, MD
Organizational Affiliation
Emergent BioSolutions
Official's Role
Study Director
Facility Information:
Facility Name
Optimal Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Alliance for Multispecialty Research - Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Velocity Clinical Research, Banning
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Optimal Research, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Accel Research Sites-DeLand Clinical Research Unit
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Optimal Research, LLC
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Suncoast Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Velocity Clinical Research, Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Optimal Research LLC
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Johnson County ClinTrials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Alliance for Multispecialty Research - Wichita East
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Optimal Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Alliance for Multispecialty Research - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Wr-Crcn, Llc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
M3 Wake Research, Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Velocity Clinical Rsearch, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aventiv Research Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Velocity Clinical Research, Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Velocity Clinical Research-Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Velocity Clinical Research, Austin
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Research Your Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
BFHC Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35709798
Citation
Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.
Results Reference
derived

Learn more about this trial

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

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