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A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox

Primary Purpose

Monkeypox

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JYNNEOS
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Monkeypox focused on measuring JYNNEOS, Monkeypox, Mpox, MVA-BN, Open-label, Pediatric, Phase 2, Public Health, Random, Vaccine

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals 18 - 50 years of age inclusive at the time of consent; OR Adolescent ages 12 to 17 years inclusive at the time of consent. Adult participant is able to read the written informed consent, states willingness to comply with all study procedures and is anticipated to be available for all study visits; OR Parent(s)/Legal Authorized Representative (LAR)(s) of the participating adolescent is able to read and provides written informed permission and participating adolescent provides assent as appropriate for age or development and approved by IRB. Adolescent states willingness to comply with all study procedures and is anticipated to be available for all study visits. . Adult participant is able to understand and agrees to adhere to Lifestyle Considerations during the study; OR Parent(s)/LAR(s) of the participating adolescent is able to understand and states willingness to comply with Lifestyle Considerations. Females of reproductive potential who have sexual intercourse with males must agree to use highly effective contraception for at least 1 month prior to signing ICF and through Day 57. NOTE: See MOP for definitions and list of acceptable and highly effective methods of contraception In good general health as evidenced by medical history, physical examination, and clinical judgement of the investigator to be in stable state of health. NOTE: Participants with pre-existing stable chronic medical conditions defined as conditions not requiring significant change in therapy or hospitalization for worsening disease in the 4 weeks prior to enrollment can be included at the discretion of the investigator. This includes stable, well-controlled HIV positive individuals. Individuals with HIV must be on suppressive ART for at least 6 months, report a CD4 count of greater than 350 cells/µL and no AIDS-defining illness in the last year. Exclusion Criteria: Ever received a licensed or an investigational smallpox or monkeypox vaccine. *This includes Dryvax, Acam2000, LC 16 m8, MVA-based vaccine candidate or licensed vaccines, and Jynneos, Imvamune or Imvanex) Any history of monkeypox, cowpox, or vaccinia infection. Close contact of anyone known to have monkeypox in the 3 weeks prior to signing ICF Immunocompromised as determined by the investigator Recent or current use of any immunosuppressing medications in the 4 weeks prior to signing ICF. **Topical, ophthalmic, inhaled, intranasal and intraarticular corticosteroids are acceptable, but receipt of >/=20 mg/day of prednisone or equivalent for >/=14 consecutive days in the 4 weeks prior to signing ICF is exclusionary. Pregnant or breast feeding. Received or plans to receive a live vaccine or any COVID-19 vaccine in the 4 weeks before or after each study vaccination. Received or plans to receive any other vaccine in the one week before or after each study vaccination. Received experimental therapeutic agent or vaccine in the 3 months prior to signing ICF. Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products. ***This includes individuals with history of severe allergic reaction to gentamicin, ciprofloxacin, chicken or egg protein. Has tattoos, scars, or other marks which would, in the opinion of the investigator, interfere with assessment of the vaccination site. Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation. ****This includes acute, subacute, intermittent, or chronic medical disease or condition that would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the participant's successful completion of this trial. Adolescent or adult participant has a history of myocarditis/pericarditis or a history of structural congenital heart defect/cardiac dysrhythmia that, in the opinion of the investigator, poses increased risk to the participant. Adolescent or adult participant has a history of COVID-19 (with positive test for SARS-CoV-2) in the 4 weeks prior to receipt of the first study vaccination. Note: This includes positive rapid antigen test, polymerase chain reaction (PCR) assay, or other nucleic acid amplification (NAAT) test including those performed by the participant at home.

Sites / Locations

  • Children's of Alabama Child Health Research Unit (CHRU)
  • George Washington University Medical Faculty Associates
  • Emory University School of Medicine
  • University of Maryland, School of Medicine, Center for Vaccine Development and Global Health
  • NIH Clinical Research Center, Investigational Drug Management and Research Section
  • Brigham and Women's Hospital
  • Saint Louis University Center for Vaccine Development
  • Washington University in St. Louis
  • University of Rochester Medical Center
  • Duke Vaccine and Trials Unit
  • Cincinnati Children's Hospital Medical Center Vaccine Research Center
  • Children's Hospital of Philadelphia
  • UPMC University Center
  • Vanderbilt University Medical Center
  • University of Texas Medical Branch
  • Baylor College of Medicine
  • Kaiser Permanente Washington Health Research Institute
  • Ponce Medical School Foundation Inc., CAIMED Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

4

5

Arm Description

0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on adults ages 18-50 years on Days 1 and 29. N=135

0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on adolescents ages 12-17 years on Days 1 and 29. N=315

Outcomes

Primary Outcome Measures

Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT) in adolescents and adults.
To determine if peak humoral immune responses in adolescents ages 12 to 17 years are non-inferior to adults after receipt of a 2-dose SC regimen of 1 x 10^8 TCID50 MVA-BN.
Occurrence of Adverse Events of Special Interest (AESI) in adolescents.
Frequency and description of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in adolescents ages 12 to 17 years.
Occurrence of Medically Attended Adverse Events (MAAE) in adolescents.
Frequency and description of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC
Occurrence of Serious Adverse Events (SAEs) in adolescents.
Frequency and relatedness of serious Adverse Events (SAE) of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in for the duration of the study.
Occurrence of solicited Adverse Events (AE) in adolescents.
Frequency and severity of solicited systemic and local Adverse Events for 7 days after each vaccination of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in adolescents ages 12 to 17 years.
Occurrence of unsolicited Adverse Events (AE) in adolescents.
Frequency severity, and relatedness of unsolicited Adverse Events after each vaccination of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in for adolescents ages 12 to 17 years.
Occurrence of withdrawals and discontinuations of vaccination in adolescents.
Frequency of occurrence within adolescents ages 12 to 17 years

Secondary Outcome Measures

Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT) in adolescents and adults
For adolescents ages 12 to 17 years compared to adults at baseline, prior to the second vaccination, and following receipt of the 2-dose SC regimen of 1 x 10^8 TCID50 MVA-BN.
Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT) in adolescents and adults
Seroconversion in adolescent study arms 1-5
Frequency of withdrawals or discontinuation of vaccination in adolescents and adults
Frequency in study arms 1-5
Occurrence of Adverse Events of Special Interest (AESI) in adolescents and adults
In study arms 1-5
Occurrence of Medically Attended Events (MAAE) in adolescents and adults
Frequency and description in study arms 1-5.
Occurrence of Medically Attended Events (MAAE) in adolescents and adults
Frequency and relatedness in study arms 1-5
Occurrence of Serious Adverse Events (SAE) in adolescents and adults
Frequency and relatedness in study arms 1-5
Occurrence of Serious Adverse Events (SAE) in adolescents and adults
Frequency and relatedness in study arms 1-5
Occurrence of solicited Adverse Events (AE) for 7 days after each vaccination in adolescents and adults
Frequency, severity, and relatedness of solicited systemic and local Adverse Events for 7 days after each vaccination in study arms 1-5.
Occurrence of unsolicited Adverse Events (AE) in adolescents and adults
Frequency, severity, and relatedness of unsolicited Adverse Events for 28 days after each vaccination; in study arms 1-5.
Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) half-life (t ½) in adolescents and adults.
For adolescents ages 12 to 17 years compared to adults following receipt of the 2-dose SC regimen of 1 x 10^8 TCID50 MVA-BN.

Full Information

First Posted
February 13, 2023
Last Updated
October 19, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05740982
Brief Title
A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
Official Title
A Phase 2 Randomized, Open-Label, Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
Study Type
Interventional

2. Study Status

Record Verification Date
September 22, 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two ID regimens for MVA-BN vaccine compared to the standard SC regimen in healthy, vaccinia-naïve adults 18 to 50 years of age, inclusive, (Stage 1). In Stage 2 of the study, the standard SC regimen will be evaluated in adolescents ages 12 through 17 years, inclusive, and compared to the standard SC regimen in adults ages 18 to 50, inclusive. In Stage 2, approximately 210 healthy, vaccinia-naïve adults will be enrolled in a comparator arm (Arm 4) and will be given the standard, licensed regimen of 1x10^8 MVA-BN administered SC on Day 1 and 29 and will be combined with adults from Arm 3 (Stage 1) to be the comparator for the primary endpoint, non-inferiority testing. Approximately 210 healthy, vaccinia-naïve adolescents will be enrolled and given 1x10^8 MVA-BN administered SC on Days 1 and 29 (Arm 5). The study will have a set target enrollment of at least 25% adolescents ages 12 to 14 years to ensure that adequate numbers of younger adolescents are enrolled. The primary objectives are 1.) To determine if peak humoral immune responses in adults ages 18-50 years following an ID regimen of 2 x 10^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10^8 TCID50 MVA-BN administered SC; 2.) To determine if peak humoral immune responses in adults ages 18-50 years following an ID regimen of 1 x 10^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10^8 TCID50 MVA-BN administered SC.
Detailed Description
This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two ID regimens for MVA-BN vaccine compared to the standard SC regimen in healthy, vaccinia-naïve adults 18 to 50 years of age, inclusive, (Stage 1). In Stage 2 of the study, the standard SC regimen will be evaluated in adolescents ages 12 through 17 years, inclusive, and compared to the standard SC regimen in adults ages 18 to 50, inclusive. In Stage 1, approximately 230 adult participants will be enrolled and randomized to one of three study arms. The two dose sparing strategies include one-fifth (2 x 10^7) and one-tenth (1 x 10^7) of the standard dose of MVA-BN administered ID on Day 1 and 29 (Arm 1 and 2, respectively). The comparator arm (Arm 3) will be the 2-dose standard (1 x 10^8) MVA-BN SC regimen. Stage 1 will enroll a 1:1:1 randomization allocation. In Stage 2, approximately 210 healthy, vaccinia-naïve adults will be enrolled in a comparator arm (Arm 4) and will be given the standard, licensed regimen of 1x10^8 MVA-BN administered SC on Day 1 and 29 and will be combined with adults from Arm 3 (Stage 1) to be the comparator for the primary endpoint, non-inferiority testing. Approximately 210 healthy, vaccinia-naïve adolescents will be enrolled and given1x10^8 MVA-BN administered SC on Days 1 and 29 (Arm 5). The study will have a set target enrollment of at least 25% adolescents ages 12 to 14 years to ensure that adequate numbers of younger adolescents are enrolled. The primary objectives are 1.) To determine if peak humoral immune responses in adults ages 18-50 years following an ID regimen of 2 x 10^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10^8 TCID50 MVA-BN administered SC; 2.) To determine if peak humoral immune responses in adults ages 18-50 years following an ID regimen of 1 x 10^7 TCID50 MVA-BN are non-inferior to the licensed regimen of 1 x 10^8 TCID50 MVA-BN administered SC. The Secondary Objectives are 1.) To determine if peak humoral immune responses in adolescents ages 12 to 17 years following administration of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC are non-inferior to the response in adults ages 18 to 50 years who received the licensed 2-dose SC regimen of 1 x 10^8 TCID50 MVA-BN; 2.) To describe safety of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in adolescents ages 12 to 17 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monkeypox
Keywords
JYNNEOS, Monkeypox, Mpox, MVA-BN, Open-label, Pediatric, Phase 2, Public Health, Random, Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4
Arm Type
Active Comparator
Arm Description
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on adults ages 18-50 years on Days 1 and 29. N=135
Arm Title
5
Arm Type
Experimental
Arm Description
0.5 mL of 1 x 10^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on adolescents ages 12-17 years on Days 1 and 29. N=315
Intervention Type
Biological
Intervention Name(s)
JYNNEOS
Intervention Description
JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus.
Primary Outcome Measure Information:
Title
Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT) in adolescents and adults.
Description
To determine if peak humoral immune responses in adolescents ages 12 to 17 years are non-inferior to adults after receipt of a 2-dose SC regimen of 1 x 10^8 TCID50 MVA-BN.
Time Frame
Day 43
Title
Occurrence of Adverse Events of Special Interest (AESI) in adolescents.
Description
Frequency and description of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in adolescents ages 12 to 17 years.
Time Frame
Day 1 through Day 210
Title
Occurrence of Medically Attended Adverse Events (MAAE) in adolescents.
Description
Frequency and description of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC
Time Frame
Day 1 through Day 210
Title
Occurrence of Serious Adverse Events (SAEs) in adolescents.
Description
Frequency and relatedness of serious Adverse Events (SAE) of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in for the duration of the study.
Time Frame
Day 1 through Day 394
Title
Occurrence of solicited Adverse Events (AE) in adolescents.
Description
Frequency and severity of solicited systemic and local Adverse Events for 7 days after each vaccination of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in adolescents ages 12 to 17 years.
Time Frame
Day 1 through Day 36
Title
Occurrence of unsolicited Adverse Events (AE) in adolescents.
Description
Frequency severity, and relatedness of unsolicited Adverse Events after each vaccination of a 2-dose 1 x 10^8 TCID50 MVA-BN regimen administered SC in for adolescents ages 12 to 17 years.
Time Frame
Day 1 through Day 57
Title
Occurrence of withdrawals and discontinuations of vaccination in adolescents.
Description
Frequency of occurrence within adolescents ages 12 to 17 years
Time Frame
Day 1 through Day 394
Secondary Outcome Measure Information:
Title
Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT) in adolescents and adults
Description
For adolescents ages 12 to 17 years compared to adults at baseline, prior to the second vaccination, and following receipt of the 2-dose SC regimen of 1 x 10^8 TCID50 MVA-BN.
Time Frame
Day 1 through Day 394
Title
Change from baseline in Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) Geometric Mean Titers (GMT) in adolescents and adults
Description
Seroconversion in adolescent study arms 1-5
Time Frame
Day 1 through Day 394
Title
Frequency of withdrawals or discontinuation of vaccination in adolescents and adults
Description
Frequency in study arms 1-5
Time Frame
Day 1 through Day 181
Title
Occurrence of Adverse Events of Special Interest (AESI) in adolescents and adults
Description
In study arms 1-5
Time Frame
Day 1 through day 210
Title
Occurrence of Medically Attended Events (MAAE) in adolescents and adults
Description
Frequency and description in study arms 1-5.
Time Frame
Day 1 through Day 210
Title
Occurrence of Medically Attended Events (MAAE) in adolescents and adults
Description
Frequency and relatedness in study arms 1-5
Time Frame
Day 1 through Day 210
Title
Occurrence of Serious Adverse Events (SAE) in adolescents and adults
Description
Frequency and relatedness in study arms 1-5
Time Frame
Day 1 through Day 181
Title
Occurrence of Serious Adverse Events (SAE) in adolescents and adults
Description
Frequency and relatedness in study arms 1-5
Time Frame
Day 1 through Day 394
Title
Occurrence of solicited Adverse Events (AE) for 7 days after each vaccination in adolescents and adults
Description
Frequency, severity, and relatedness of solicited systemic and local Adverse Events for 7 days after each vaccination in study arms 1-5.
Time Frame
Day 1 through Day 36
Title
Occurrence of unsolicited Adverse Events (AE) in adolescents and adults
Description
Frequency, severity, and relatedness of unsolicited Adverse Events for 28 days after each vaccination; in study arms 1-5.
Time Frame
Day 1 through Day 57
Title
Vaccinia virus specific plaque reduction neutralizing antibody (PRNT) half-life (t ½) in adolescents and adults.
Description
For adolescents ages 12 to 17 years compared to adults following receipt of the 2-dose SC regimen of 1 x 10^8 TCID50 MVA-BN.
Time Frame
Day 1 through Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals 18 - 50 years of age inclusive at the time of consent; OR Adolescent ages 12 to 17 years inclusive at the time of consent. Adult participant is able to read the written informed consent, states willingness to comply with all study procedures and is anticipated to be available for all study visits; OR Parent(s)/Legal Authorized Representative (LAR)(s) of the participating adolescent is able to read and provides written informed permission and participating adolescent provides assent as appropriate for age or development and approved by IRB. Adolescent states willingness to comply with all study procedures and is anticipated to be available for all study visits. . Adult participant is able to understand and agrees to adhere to Lifestyle Considerations during the study; OR Parent(s)/LAR(s) of the participating adolescent is able to understand and states willingness to comply with Lifestyle Considerations. Females of reproductive potential who have sexual intercourse with males must agree to use highly effective contraception for at least 1 month prior to signing ICF and through Day 57. NOTE: See MOP for definitions and list of acceptable and highly effective methods of contraception In good general health as evidenced by medical history, physical examination, and clinical judgement of the investigator to be in stable state of health. NOTE: Participants with pre-existing stable chronic medical conditions defined as conditions not requiring significant change in therapy or hospitalization for worsening disease in the 4 weeks prior to enrollment can be included at the discretion of the investigator. This includes stable, well-controlled HIV positive individuals. Individuals with HIV must be on suppressive ART for at least 6 months, report a CD4 count of greater than 350 cells/µL and no AIDS-defining illness in the last year. Exclusion Criteria: Ever received a licensed or an investigational smallpox or monkeypox vaccine. *This includes Dryvax, Acam2000, LC 16 m8, MVA-based vaccine candidate or licensed vaccines, and Jynneos, Imvamune or Imvanex) Any history of monkeypox, cowpox, or vaccinia infection. Close contact of anyone known to have monkeypox in the 3 weeks prior to signing ICF Immunocompromised as determined by the investigator Recent or current use of any immunosuppressing medications in the 4 weeks prior to signing ICF. **Topical, ophthalmic, inhaled, intranasal and intraarticular corticosteroids are acceptable, but receipt of >/=20 mg/day of prednisone or equivalent for >/=14 consecutive days in the 4 weeks prior to signing ICF is exclusionary. Pregnant or breast feeding. Received or plans to receive a live vaccine or any COVID-19 vaccine in the 4 weeks before or after each study vaccination. Received or plans to receive any other vaccine in the one week before or after each study vaccination. Received experimental therapeutic agent or vaccine in the 3 months prior to signing ICF. Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products. ***This includes individuals with history of severe allergic reaction to gentamicin, ciprofloxacin, chicken or egg protein. Has tattoos, scars, or other marks which would, in the opinion of the investigator, interfere with assessment of the vaccination site. Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation. ****This includes acute, subacute, intermittent, or chronic medical disease or condition that would place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the participant's successful completion of this trial. Adolescent or adult participant has a history of myocarditis/pericarditis or a history of structural congenital heart defect/cardiac dysrhythmia that, in the opinion of the investigator, poses increased risk to the participant. Adolescent or adult participant has a history of COVID-19 (with positive test for SARS-CoV-2) in the 4 weeks prior to receipt of the first study vaccination. Note: This includes positive rapid antigen test, polymerase chain reaction (PCR) assay, or other nucleic acid amplification (NAAT) test including those performed by the participant at home.
Facility Information:
Facility Name
Children's of Alabama Child Health Research Unit (CHRU)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-0011
Country
United States
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1014
Country
United States
Facility Name
University of Maryland, School of Medicine, Center for Vaccine Development and Global Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1509
Country
United States
Facility Name
NIH Clinical Research Center, Investigational Drug Management and Research Section
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1504
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6110
Country
United States
Facility Name
Saint Louis University Center for Vaccine Development
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104-1015
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Facility Name
Duke Vaccine and Trials Unit
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center Vaccine Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
UPMC University Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0435
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101-1466
Country
United States
Facility Name
Ponce Medical School Foundation Inc., CAIMED Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://redcap.urmc.rochester.edu/redcap/surveys/?s=JMH3HYMFDR8NC4TN&ch=nGKWR220ERw3u8y5cf
Description
MPox Vaccination Study Survey for adolescent participants interested in enrolling at the University of Rochester Medical Center

Learn more about this trial

A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox

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