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A Phase III Randomised, Open Label Trial of an Intradermal or Subcutaneous booster dose of MVA-BN Vaccine to Investigate MPXV Immunogenicity and Safety for Protection Against Mpox in an Intradermally or Subcutaneously Primary Vaccinated Population – an adaptive protocol and a Non-Randomised Trial of a Subcutaneous Booster Dose for Subcutaneously Primary Vaccinated
EU CTIS ID: 2024-518007-22-00
What this study is testing
To determine if an MVA-BN booster dose administered ID is non-inferior to SC in inducing a detectable humoral immune-response at 1 month
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged ≥ 18 years old
- ≥18 years old who 4 months ago or earlier received 1x10^8 TCID50 MVA-BN in a 2-dose SC or 2x10^7 TCID50 MVA-BN ID regime approximately four to twelve weeks apart in line with public health recommendations in Belgium, or previously smallpox vaccinated individuals who have received only one dose 1x10^8 TCID50 MVA-BN SC as a primary regimen. (Belgian trial sites)
- Received a dose of MVA-BN vaccine at least 4 months ago
- Individuals who are willing and able to participate and have signed written consent to participate in the study.
- Individuals who expect to be available for monitoring during the entire study period.
- Men who have sex with men (Swedish, Irish and Belgian trial sites)
You likely can't join if
- Individuals with hypersensitivity to the active substance or excipient contained in the vaccine
- Individuals with a history of mpox (including laboratory-confirmed), or any orthopoxvirus (except small pox vaccination) prior to the vaccination offered for protection against mpox, based on volunteer-reported medical history
- Individuals with high-risk exposure with a suspected or confirmed mpox in the 3 weeks prior to signing the informed consent form
- Positive pregnancy test or persons of childbearing potential
- Having received more than 2 doses of MVA-BN against mpox
- Individuals scheduled to receive another vaccine within 14 days prior to or after the MVA-BN booster dose
See the full eligibility criteria
Who can join
- Adults aged ≥ 18 years old
- ≥18 years old who 4 months ago or earlier received 1x10^8 TCID50 MVA-BN in a 2-dose SC or 2x10^7 TCID50 MVA-BN ID regime approximately four to twelve weeks apart in line with public health recommendations in Belgium, or previously smallpox vaccinated individuals who have received only one dose 1x10^8 TCID50 MVA-BN SC as a primary regimen. (Belgian trial sites)
- Received a dose of MVA-BN vaccine at least 4 months ago
- Individuals who are willing and able to participate and have signed written consent to participate in the study.
- Individuals who expect to be available for monitoring during the entire study period.
- Men who have sex with men (Swedish, Irish and Belgian trial sites)
- ≥18 years old who 4 months ago or earlier received 2x10^7 TCID50 MVA-BN in a 2-dose ID regime approximately four weeks apart in line with public health recommendations in Sweden, or previously smallpox vaccinated individuals who have received only one dose 2x10^7 TCID50 MVA-BN ID as a primary regimen. (Swedish trial sites)
- ≥18 years old who 4 months ago or earlier received 1x10^8 TCID50 MVA-BN in a 2-dose SC or ID regime approximately four weeks apart in line with public health recommendations in Ireland, or previously smallpox vaccinated individuals who have received only one dose 1x10^8 TCID50 MVA-BN SC as a primary regimen. (Irish trial sites)
- Eligible for a booster dose, as recommended by the Haute Autorité de Santé (French trial sites)
- For women testing negative in pregnancy test (French trial sites)
What rules you out
- Individuals with hypersensitivity to the active substance or excipient contained in the vaccine
- Individuals with a history of mpox (including laboratory-confirmed), or any orthopoxvirus (except small pox vaccination) prior to the vaccination offered for protection against mpox, based on volunteer-reported medical history
- Individuals with high-risk exposure with a suspected or confirmed mpox in the 3 weeks prior to signing the informed consent form
- Positive pregnancy test or persons of childbearing potential
- Having received more than 2 doses of MVA-BN against mpox
- Individuals scheduled to receive another vaccine within 14 days prior to or after the MVA-BN booster dose
- Individuals who are unable to understand the research subject information
- Individuals participating in another interventional clinical trial
- Individuals who for other reasons are judged by investigators to be unsuitable for inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.