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Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC

Primary Purpose

Monkeypox

Status
Recruiting
Phase
Phase 4
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
MVA-BN vaccine
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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Provides written informed consent 18 years of age or older At high risk for Monkeypox infections Personnel and staff associated with the PALM 007-Monkeypox study sites in the DRC Willingness and ability to communicate AEs to study personnel Exclusion Criteria: Allergy to MVA-BN or any of its components Pregnant or breastfeeding women Fever (axillary temperature ≥37.5°celsius) People who have already received the MVA-BN vaccine (in routine vaccination or another study involving this vaccine) Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study Individuals with any condition or circumstance that would render them unable to comply with study procedures (e.g., not reachable by phone)

Sites / Locations

  • Institut National de Rescherche Biomédicale (INRB)
  • L'Hôpital Général de Référence de KoleRecruiting
  • L'Hôpital Général de Référence de Tunda

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MVA-BN vaccine

Arm Description

2 doses of 0.5 mL MVA-BN vaccine injected subcutaneously and given at least 28 days apart

Outcomes

Primary Outcome Measures

Frequency of SAEs after each dose of MVA-BN vaccine
Number of SAEs
Severity of SAEs after each dose of MVA-BN vaccine
Grade of SAEs
Frequency of AEs after each dose of MVA-BN vaccine
Number of AEs
Severity of AEs after each dose of MVA-BN vaccine
Grade of AEs

Secondary Outcome Measures

Full Information

First Posted
February 7, 2023
Last Updated
March 27, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
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1. Study Identification

Unique Protocol Identification Number
NCT05734508
Brief Title
Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC
Official Title
Cohort Events Monitoring (CEM) Study for the Assessment of Safety Profile of MVA-BN (Jynneos) Vaccine in Adult Personnel and Staff in the PALM-007 Study in Democratic Republic Of The Congo
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this observational study is to monitor and assess the safety profile of the MVA-BN vaccine among staff and study personnel of the PALM-007 study in the Democratic Republic of the Congo. The main questions it aims to answer are: To estimate the incidence of serious adverse events (SAEs) in all individuals vaccinated with the MVA-BN vaccine To estimate the incidence of adverse events (AEs) after each dose of MVA-BN vaccine. Participants will receive two doses of vaccine and will be actively followed up to the 28th day after their last dose of MVA-BN vaccine.
Detailed Description
All personnel and staff of the PALM-007 study will be offered the opportunity to participate in the study by reviewing and signing the informed consent. After signing informed consent, participants will be examined. The following parameters will be assessed: Anthropometric measurements (weight, height) Vital signs: temperature (axillary), blood pressure, heart rate and respiratory rate Medical history, including history of orthopox virus disease, vaccination, current co-morbidities and medication(s) Physical examination Pregnancy test will be done for all women of childbearing potential If a participant has met all eligibility criteria, they will be enrolled and will receive the vaccine as specified below. Participants who are excluded because of fever can be rescreened and included after resolution of the fever and its cause. Enrolled participants will receive the MVA-BN vaccine by subcutaneous injection of 0.5 mL in the shoulder (left or right). The first dose will be administered at the time of enrollment and the second dose 28 days later. After each vaccination, the participant will remain under observation for 30 minutes. All AEs occurring during this period of observation will be recorded and reported to the National Center for Pharmacovigilance and to the ethics committee according to Congolese regulations. Follow-up of participants: Participants will be followed until 28 days after the second dose of vaccine. Follow-up visit will be done either in person at National Institute of Biomedical Research (INRB) in Kinshasa and at the Monkeypox treatment centers in the PALM-007 study or by phone calls on Day 3, Day 14, and Day 28 post each vaccination. Study participants will be provided with contact information of vaccine research staff and have the right to contact the research team either directly or by phone if they have any questions about post-vaccination reactions they may be experiencing or if they are concerned. There is a window of +/- one day for each study visit except the day of the second dose which can be done on day 28 after the first dose with a window of +7 days. This second dose must not be given before Day 28. During each visit, participants will be asked to report to the research team AEs via open-ended questions. All SAEs will be followed-up. SAEs that have not resolved by the end of the per-protocol follow-up period for the subject (Day 28 after second dose) are to be followed until final outcome is known (to the degree permitted by the IRB-approved informed consent form). If it is not possible to obtain a final outcome for an SAE (e.g., the participant is lost to follow-up), the last known status and the reason a final outcome could not be obtained will be recorded by the investigator on an SAE report update and the CRF. On the day of administration of the second dose of vaccine, vital signs, and physical examination will be done to all participants and a pregnancy test will be done on all women of childbearing potential prior to vaccine administration. If the pregnancy test is positive, the second dose will not be given, and the participant will be followed up as described in the protocol. Participants will be instructed to report any AEs that are experienced outside of the protocol defined follow up days. The reporting form of the national pharmacovigilance system of the DRC will be used for reporting. The research team will complete the notification form which will be sent to the National Pharmacovigilance Center (CNPV) by e-mail (scanned copies).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MVA-BN vaccine
Arm Type
Experimental
Arm Description
2 doses of 0.5 mL MVA-BN vaccine injected subcutaneously and given at least 28 days apart
Intervention Type
Biological
Intervention Name(s)
MVA-BN vaccine
Other Intervention Name(s)
JYNNEOS
Intervention Description
A live vaccine produced from the Modified Vaccinia Ankara-Bavarian Nordic strain (MVA-BN), an attenuated and non-replicating orthopox virus
Primary Outcome Measure Information:
Title
Frequency of SAEs after each dose of MVA-BN vaccine
Description
Number of SAEs
Time Frame
up to 14 days after each vaccine dose
Title
Severity of SAEs after each dose of MVA-BN vaccine
Description
Grade of SAEs
Time Frame
up to 14 days after each vaccine dose
Title
Frequency of AEs after each dose of MVA-BN vaccine
Description
Number of AEs
Time Frame
up to 28 days after each vaccine dose
Title
Severity of AEs after each dose of MVA-BN vaccine
Description
Grade of AEs
Time Frame
up to 28 days after each vaccine dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provides written informed consent 18 years of age or older At high risk for Monkeypox infections Personnel and staff associated with the PALM 007-Monkeypox study sites in the DRC Willingness and ability to communicate AEs to study personnel Exclusion Criteria: Allergy to MVA-BN or any of its components Pregnant or breastfeeding women Fever (axillary temperature ≥37.5°celsius) People who have already received the MVA-BN vaccine (in routine vaccination or another study involving this vaccine) Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study Individuals with any condition or circumstance that would render them unable to comply with study procedures (e.g., not reachable by phone)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Tshiani Mbaya, MD MTM&GH
Phone
+1-240-529-4773
Email
olivier.tshianimbaya@nih.gov
Facility Information:
Facility Name
Institut National de Rescherche Biomédicale (INRB)
City
Kinshasa
Country
Congo, The Democratic Republic of the
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nsengi Ntamabyaliro, MD, MSc
Phone
+243815171991
First Name & Middle Initial & Last Name & Degree
Aline Engo Biongo, MD
Phone
+243998863986
Facility Name
L'Hôpital Général de Référence de Kole
City
Kole
Country
Congo, The Democratic Republic of the
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Placide Mbala, MD, PhD
Phone
+243822851584
Email
mbalaplacide@gmail.com
First Name & Middle Initial & Last Name & Degree
Jules Alonga, MD
Phone
+243825123351
Email
alongajules@gmail.com
Facility Name
L'Hôpital Général de Référence de Tunda
City
Tunda
Country
Congo, The Democratic Republic of the
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Placide Mbala, MD, PhD
Phone
+2438251584
Email
mbalaplacide@gmail.com
First Name & Middle Initial & Last Name & Degree
Freddy Yemba, MD
Phone
+243815334879
Email
Fredyy@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC

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