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Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination

Primary Purpose

Chikungunya Virus Infection

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PXVX0317 vaccine booster
Placebo booster
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chikungunya Virus Infection focused on measuring Chikungunya, PXVX0317, Vaccine, Immunogenicity, CHIKV VLP

Eligibility Criteria

12 Years - 67 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Within the feeder study informed consent form (ICF) (and/or assent form, as applicable), the participant voluntarily signed and agreed to be contacted by the sponsor for potential screening and enrollment in a future study (ie, EBSI-CV-317-008). Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable) for participation in this rollover study EBSI-CV-317-008, including possible receipt of a booster dose of PXVX0317. Males or females, 12 to <65 years of age at the time of enrollment in the feeder study. Received a single dose of PXVX0317 vaccine in the feeder study. Demonstrated compliance to the feeder study conduct (ie, rollover participant was without protocol deviations that excluded them from analysis in feeder study EBSI-CV-317-004) without discontinuation or early withdrawal. Generally healthy, in the opinion of the investigator, based on medical history and physical examination. Additional inclusion criteria to be assessed at Prerandomization Visit (Visit 5) and Randomization Visit (Visit 6) to determine eligibility for a booster: - Women who are either: i. Not of childbearing potential (CBP): premenarche, surgically sterile (at least six weeks postbilateral tubal ligation or bilateral total salpingectomy, 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). For women who are postmenopausal, documented follicle stimulating hormone (FSH) level of ≥40 mIU/mL must be obtained. If the FSH is <40 mIU/mL, the participant must agree to use an acceptable form of contraception. or: ii. Meet all the below criteria: Negative serum pregnancy test at Prerandomization Visit Negative urine pregnancy test at Prebooster Visit and immediately prior to booster dose administration Use one of these acceptable methods of contraception (if women of CBP) for at least six months after booster: Hormonal contraceptives (eg, implants, pills, patches) initiated ≥30 days prior to booster dose administration Intrauterine device (IUD) inserted ≥30 days prior to booster dose administration 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 of age) who are not sexually active. Women participants of CBP must use an acceptable method of contraception from ≥30 days prior to randomization through six-months postbooster vaccination dose (if applicable). Note: Contraception requirements do not apply for participants in exclusively same-sex relationships and these participants should have no plans to become pregnant by any other means for the duration of the study. Contraception requirements do not apply to Group 4 participants (unrandomized or unboosted). Exclusion Criteria: Received placebo treatment in the feeder study. Measurable anti-CHIKV SNA at Day 1 in the feeder study. History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP). Receipt of either an investigational or licensed CHIKV vaccine (excluding prior receipt of PXVX0317). New onset/diagnosis of any disease falling within the feeder study exclusion criteria including: i. 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) or ii. Clinically significant cardiac, pulmonary, rheumatologic, or other chronic disease, in the opinion of the investigator. This may include chronic illness requiring hospitalization during the feeder study. Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the individual's participation or the conduct of the study. Any other medical condition or general reason that, in the opinion of the investigator, could adversely impact the individual's participation or the conduct of the study. Participation or planned participation in an investigational clinical trial, excluding feeder study EBSI-CV-317-004 (eg, vaccine, drug, medical device, or medical procedure) for the duration of this study. Note: Participation in an observational trial or follow-up phase of a trial may be allowed; however, these instances should be discussed with this study's medical monitor (MM). Additional exclusion criteria to be assessed at Prerandomization Visit (Visit 5), Randomization Visit (Visit 6), and Prebooster (for Groups 2 and 3) Visit(s) to determine eligibility for a booster: Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to Prebooster Visit through 21 days after booster dose. 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 Prebooster Visit through 21 days postbooster dose 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 Prebooster Visit through 21 days postbooster dose. Acute disease within the last 14 days prior to booster dose (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). Receipt or anticipated receipt of any vaccine from 30 days prior to booster dose through 21 days postbooster. Experienced a related safety event in the feeder study that, in the investigator's judgement, precludes receipt of booster. Note: Participants that are ineligible or decline booster will be included in Group 4 (unrandomized or unboosted) for follow-up unless consent/assent for follow-up is withdrawn.

Sites / Locations

  • Wr-Crcn, LlcRecruiting
  • Rochester Clinical Research, LLCRecruiting
  • M3 Wake Research Inc.Recruiting
  • Lynn Institute of NormanRecruiting
  • DM Clinical ResearchRecruiting
  • DM Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Group 1a

Group 1b

Group 2a

Group 2b

Group 3a

Group 3b

Group 4

Arm Description

PXVX0317 vaccine booster, 3 years post initial vaccination

Placebo booster, 3 years post initial vaccination

PXVX0317 vaccine booster, 4 years post initial vaccination

Placebo booster, 4 years post initial vaccination

PXVX0317 vaccine booster, 5 years post initial vaccination

Placebo booster, 5 years post initial vaccination

Unrandomized or unboosted participants, for any reason

Outcomes

Primary Outcome Measures

Proportion of participants maintaining an anti-CHIKV SNA titer ≥100 at yearly intervals up to 5 years post-initial vaccination
For immunogenicity evaluable population (IEP) participants who do not receive a PXVX0317 booster (Groups 1b, 2b, 3b, or Group 4 [unrandomized or unboosted]), proportion of participants maintaining an anti-CHIKV SNA titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years post-initial vaccination in feeder study EBSI-CV-317-004.
Proportion of vaccine boosted participants with composite booster response at 21 days after booster vaccination
For IEP participants who receive a PXVX0317 booster (Groups 1a, 2a, and 3a), proportion of participants with a boost response is defined as a composite of: ≥4-fold rise in anti-CHIKV SNA titer from prebooster to postbooster measured at 21 days after booster for participants with a prebooster titer ≥100 OR Anti-CHIKV SNA titer ≥100 and ≥4-fold increase in anti-CHIKV SNA titer from prebooster to postbooster measured at 21 days after booster vaccination for participants with a prebooster titer <100. Note: Prebooster is the last SNA sample prior to booster dose, ideally the sample on boost day prior to booster dose administration but can be the time point prior if the boost day sample is missed or incorrectly processed.

Secondary Outcome Measures

Anti-CHIKV SNA Geometric Mean Titers (GMTs) at yearly intervals
For all groups using the IEP, anti-CHIKV SNA GMTs at yearly intervals up to 5 years post-initial PXVX0317 vaccination in feeder study EBSI-CV-317-004 and, in Groups 1a, 2a, and 3a (PXVX0317 IEP booster population), at 21 days postboost.
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI) Prebooster to Postbooster
For IEP participants who receive a PXVX0317 booster (Groups 1a, 2a, and 3a; PXVX0317 IEP booster population) and have a 21-day postbooster SNA titer, GMFI from prebooster anti-CHIKV SNA titer to 21 days postbooster anti-CHIKV SNA titer and at yearly intervals up to 5 years post-initial vaccination in feeder study EBSI-CV-317-004.
Booster Response at 21 Days Relative to 21-day Response in Feeder Study EBSI-CV-317-004
For IEP participants who receive a PXVX0317 booster (Groups 1a, 2a, and 3a; PXVX0317 IEP booster population) and have a 21-day postboost SNA titer, GMFI from feeder study EBSI-CV-317-004 Day 22 SNA titer to 21-day postbooster SNA titer in the rollover study.

Full Information

First Posted
August 18, 2023
Last Updated
September 29, 2023
Sponsor
Bavarian Nordic
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1. Study Identification

Unique Protocol Identification Number
NCT06007183
Brief Title
Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination
Official Title
A Long-term Follow-up Study to Evaluate Safety and Immunogenicity of a Chikungunya Virus Virus-like Particle Vaccine (PXVX0317) in Healthy Adults and Adolescents After Either a Single or Booster Vaccination Dosing Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
April 2028 (Anticipated)
Study Completion Date
August 2028 (Anticipated)

3. Sponsor/Collaborators

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

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 purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of PXVX0317 in adult and adolescent participants and to evaluate PXVX0317 booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial PXVX0317 vaccination.
Detailed Description
Primary Objectives: To evaluate the long-term immunogenicity of PXVX0317 vaccine in healthy adult and adolescent participants as measured by proportion of participants maintaining an anti-CHIKV serum neutralizing antibody (SNA) titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years postvaccination in feeder study EBSI-CV-317-004 (NCT05072080). To assess the vaccine-induced SNA titers by a booster dose of PXVX0317 vaccine at 3, 4, or 5 years post-initial vaccination in feeder study EBSI-CV- 317-004. To evaluate the safety and tolerability of PXVX0317 in all participants. To evaluate the safety and tolerability of a booster vaccination and compare with safety and tolerability reported post-initial vaccination of PXVX0317 under feeder study EBSI-CV-317-004 in healthy adults and adolescents. Secondary Objectives: To evaluate the long-term immunogenicity of PXVX0317 vaccine in healthy adult and adolescent participants as measured by anti-CHIKV SNA geometric mean titers (GMTs) at yearly intervals up to 5 years post-initial vaccination in feeder study EBSI-CV-317-004. To evaluate the immune response to a booster vaccination and compare this response to that reported post-initial vaccination of PXVX0317 under feeder study EBSI-CV-317-004 in healthy adults and adolescents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Virus Infection
Keywords
Chikungunya, PXVX0317, Vaccine, Immunogenicity, CHIKV VLP

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants still in the study at the Year 3 timepoint (time point relative to initial vaccination in feeder study EBSI-CV-317-004) will be randomized 1:1:1 to Year 3, 4, or 5 and 1:1 to PXVX0317 booster or placebo booster.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Participants, care providers, and investigator will not be blinded for the timing of when the participant will receive the vaccine booster or placebo booster. They will be blinded to all booster treatment assignments (vaccine booster or placebo booster).
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1a
Arm Type
Active Comparator
Arm Description
PXVX0317 vaccine booster, 3 years post initial vaccination
Arm Title
Group 1b
Arm Type
Placebo Comparator
Arm Description
Placebo booster, 3 years post initial vaccination
Arm Title
Group 2a
Arm Type
Active Comparator
Arm Description
PXVX0317 vaccine booster, 4 years post initial vaccination
Arm Title
Group 2b
Arm Type
Placebo Comparator
Arm Description
Placebo booster, 4 years post initial vaccination
Arm Title
Group 3a
Arm Type
Active Comparator
Arm Description
PXVX0317 vaccine booster, 5 years post initial vaccination
Arm Title
Group 3b
Arm Type
Placebo Comparator
Arm Description
Placebo booster, 5 years post initial vaccination
Arm Title
Group 4
Arm Type
No Intervention
Arm Description
Unrandomized or unboosted participants, for any reason
Intervention Type
Biological
Intervention Name(s)
PXVX0317 vaccine booster
Other Intervention Name(s)
CHIKV VLP
Intervention Description
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP) 40mg, aluminum hydroxide 2% adjuvant, and formulation buffer supplied as a single dose of 0.8 mL in a pre-filled syringe, to be administered via intramuscular (IM) injection in the deltoid muscle.
Intervention Type
Biological
Intervention Name(s)
Placebo booster
Intervention Description
Placebo is comprised of formulation buffer supplied as a single dose of 0.8 mL in a pre-filled syringe administered via IM injection in the deltoid muscle.
Primary Outcome Measure Information:
Title
Proportion of participants maintaining an anti-CHIKV SNA titer ≥100 at yearly intervals up to 5 years post-initial vaccination
Description
For immunogenicity evaluable population (IEP) participants who do not receive a PXVX0317 booster (Groups 1b, 2b, 3b, or Group 4 [unrandomized or unboosted]), proportion of participants maintaining an anti-CHIKV SNA titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years post-initial vaccination in feeder study EBSI-CV-317-004.
Time Frame
5 years post-initial vaccination in feeder study EBSI-CV-317-004
Title
Proportion of vaccine boosted participants with composite booster response at 21 days after booster vaccination
Description
For IEP participants who receive a PXVX0317 booster (Groups 1a, 2a, and 3a), proportion of participants with a boost response is defined as a composite of: ≥4-fold rise in anti-CHIKV SNA titer from prebooster to postbooster measured at 21 days after booster for participants with a prebooster titer ≥100 OR Anti-CHIKV SNA titer ≥100 and ≥4-fold increase in anti-CHIKV SNA titer from prebooster to postbooster measured at 21 days after booster vaccination for participants with a prebooster titer <100. Note: Prebooster is the last SNA sample prior to booster dose, ideally the sample on boost day prior to booster dose administration but can be the time point prior if the boost day sample is missed or incorrectly processed.
Time Frame
21 days after booster vaccination
Secondary Outcome Measure Information:
Title
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at yearly intervals
Description
For all groups using the IEP, anti-CHIKV SNA GMTs at yearly intervals up to 5 years post-initial PXVX0317 vaccination in feeder study EBSI-CV-317-004 and, in Groups 1a, 2a, and 3a (PXVX0317 IEP booster population), at 21 days postboost.
Time Frame
5 years post-initial vaccination in feeder study EBSI-CV-317-004
Title
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI) Prebooster to Postbooster
Description
For IEP participants who receive a PXVX0317 booster (Groups 1a, 2a, and 3a; PXVX0317 IEP booster population) and have a 21-day postbooster SNA titer, GMFI from prebooster anti-CHIKV SNA titer to 21 days postbooster anti-CHIKV SNA titer and at yearly intervals up to 5 years post-initial vaccination in feeder study EBSI-CV-317-004.
Time Frame
21 days after booster vaccination and 5 years post-initial vaccination in feeder study EBSI-CV-317-004
Title
Booster Response at 21 Days Relative to 21-day Response in Feeder Study EBSI-CV-317-004
Description
For IEP participants who receive a PXVX0317 booster (Groups 1a, 2a, and 3a; PXVX0317 IEP booster population) and have a 21-day postboost SNA titer, GMFI from feeder study EBSI-CV-317-004 Day 22 SNA titer to 21-day postbooster SNA titer in the rollover study.
Time Frame
21 days after booster vaccination
Other Pre-specified Outcome Measures:
Title
Proportion of vaccine boosted participants with local or systemic solicited adverse events (AEs) within 7 days after booster vaccination
Description
Proportion of participants with local or systemic solicited AEs of increased frequency or severity after a booster vaccination of PXVX0317 (Groups 1a, 2a, and 3a) as compared with those reported by the same participants after initial vaccination of PXVX0317 under the feeder study (EBSI-CV-317-004) in healthy adults and adolescents.
Time Frame
7 days after booster vaccination
Title
Proportion of vaccine or placebo boosted participants with of unsolicited Adverse Events (AEs)
Description
Occurrence of unsolicited AEs within 28 days postbooster (Groups 1, 2, and 3).
Time Frame
28 days after booster vaccination
Title
Proportion of vaccine or placebo boosted participants with of Adverse Events of Special Interest (AESI)
Description
Occurrence of AESI, through the duration of the study for all participants.
Time Frame
5 years post-initial vaccination in the feeder study for Groups 1, 2 and 4; 5.5 years post-initial vaccination in the feeder study for Group 3
Title
Proportion of vaccine or placebo boosted participants with Medically Attended Adverse Event (MAAE)
Description
Occurrence of MAAE, through the duration of the study for all participants.
Time Frame
5 years post-initial vaccination in the feeder study for Groups 1, 2 and 4; 5.5 years post-initial vaccination in the feeder study for Group 3
Title
Proportion of participants with Serious Adverse Events (SAEs)
Description
Occurrence of SAEs through the duration of the study for all participants.
Time Frame
5 years post-initial vaccination in the feeder study for Groups 1, 2 and 4; 5.5 years post-initial vaccination in the feeder study for Group 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Within the feeder study informed consent form (ICF) (and/or assent form, as applicable), the participant voluntarily signed and agreed to be contacted by the sponsor for potential screening and enrollment in a future study (ie, EBSI-CV-317-008). Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable) for participation in this rollover study EBSI-CV-317-008, including possible receipt of a booster dose of PXVX0317. Males or females, 12 to <65 years of age at the time of enrollment in the feeder study. Received a single dose of PXVX0317 vaccine in the feeder study. Demonstrated compliance to the feeder study conduct (ie, rollover participant was without protocol deviations that excluded them from analysis in feeder study EBSI-CV-317-004) without discontinuation or early withdrawal. Generally healthy, in the opinion of the investigator, based on medical history and physical examination. Additional inclusion criteria to be assessed at Prerandomization Visit (Visit 5) and Randomization Visit (Visit 6) to determine eligibility for a booster: - Women who are either: i. Not of childbearing potential (CBP): premenarche, surgically sterile (at least six weeks postbilateral tubal ligation or bilateral total salpingectomy, 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). For women who are postmenopausal, documented follicle stimulating hormone (FSH) level of ≥40 mIU/mL must be obtained. If the FSH is <40 mIU/mL, the participant must agree to use an acceptable form of contraception. or: ii. Meet all the below criteria: Negative serum pregnancy test at Prerandomization Visit Negative urine pregnancy test at Prebooster Visit and immediately prior to booster dose administration Use one of these acceptable methods of contraception (if women of CBP) for at least six months after booster: Hormonal contraceptives (eg, implants, pills, patches) initiated ≥30 days prior to booster dose administration Intrauterine device (IUD) inserted ≥30 days prior to booster dose administration 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 of age) who are not sexually active. Women participants of CBP must use an acceptable method of contraception from ≥30 days prior to randomization through six-months postbooster vaccination dose (if applicable). Note: Contraception requirements do not apply for participants in exclusively same-sex relationships and these participants should have no plans to become pregnant by any other means for the duration of the study. Contraception requirements do not apply to Group 4 participants (unrandomized or unboosted). Exclusion Criteria: Received placebo treatment in the feeder study. Measurable anti-CHIKV SNA at Day 1 in the feeder study. History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP). Receipt of either an investigational or licensed CHIKV vaccine (excluding prior receipt of PXVX0317). New onset/diagnosis of any disease falling within the feeder study exclusion criteria including: i. 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) or ii. Clinically significant cardiac, pulmonary, rheumatologic, or other chronic disease, in the opinion of the investigator. This may include chronic illness requiring hospitalization during the feeder study. Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the individual's participation or the conduct of the study. Any other medical condition or general reason that, in the opinion of the investigator, could adversely impact the individual's participation or the conduct of the study. Participation or planned participation in an investigational clinical trial, excluding feeder study EBSI-CV-317-004 (eg, vaccine, drug, medical device, or medical procedure) for the duration of this study. Note: Participation in an observational trial or follow-up phase of a trial may be allowed; however, these instances should be discussed with this study's medical monitor (MM). Additional exclusion criteria to be assessed at Prerandomization Visit (Visit 5), Randomization Visit (Visit 6), and Prebooster (for Groups 2 and 3) Visit(s) to determine eligibility for a booster: Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV). Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to Prebooster Visit through 21 days after booster dose. 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 Prebooster Visit through 21 days postbooster dose 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 Prebooster Visit through 21 days postbooster dose. Acute disease within the last 14 days prior to booster dose (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). Receipt or anticipated receipt of any vaccine from 30 days prior to booster dose through 21 days postbooster. Experienced a related safety event in the feeder study that, in the investigator's judgement, precludes receipt of booster. Note: Participants that are ineligible or decline booster will be included in Group 4 (unrandomized or unboosted) for follow-up unless consent/assent for follow-up is withdrawn.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sufia Muhammad, MD
Phone
240-631-3573
Email
SUMU@bavarian-nordic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Ajiboye, MD
Organizational Affiliation
Bavarian Nordic
Official's Role
Study Director
Facility Information:
Facility Name
Wr-Crcn, Llc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie Carter
Phone
702-893-8968
Email
dcarter@wakeresearch.com
First Name & Middle Initial & Last Name & Degree
Liliana Ruiz-Leon, DO
Facility Name
Rochester Clinical Research, LLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Kelly
Phone
585-288-0890
Email
jkelly@rcrclinical.com
First Name & Middle Initial & Last Name & Degree
Carolyn DiPoala
Phone
585-288-0890
Email
cdipoala@rcrclinical.com
First Name & Middle Initial & Last Name & Degree
Matthew G Davis, MD
Facility Name
M3 Wake Research Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Henderson
Phone
919-784-2514
Email
ehenderson@wakeresearch.com
First Name & Middle Initial & Last Name & Degree
Lisa Cohen, DO
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathi Shaw
Phone
405-602-3939
Email
kshaw@lhsi.net
First Name & Middle Initial & Last Name & Degree
Sharee Wright
Phone
405-602-3939
Email
swright@lhsi.net
First Name & Middle Initial & Last Name & Degree
Steven Cox, DO
Facility Name
DM Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chance Caddell
Phone
713-838-2022
Email
chance.caddell@dmclinical.com
First Name & Middle Initial & Last Name & Degree
Mary Rogers
Phone
713-838-2022
Email
mary.rogers@dmclinical.com
First Name & Middle Initial & Last Name & Degree
Vicki Miller, MD
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Trier
Phone
281-517-0550
Email
mtrier@dmclinical.com
First Name & Middle Initial & Last Name & Degree
Muhammad Irfan, MD

12. IPD Sharing Statement

Learn more about this trial

Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination

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