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The effect of a booster vaccination on protection against the mpox virus: is a booster vaccination with a lower dose as effective as the standard dose (SUBO trial)?
EU CTIS ID: 2024-510697-24-00
What this study is testing
To determine non-inferiority of the antibody response two weeks after subcutaneous delivery of the fractional booster dose of MVA-BN vaccine in adults, compared to subcutaneous delivery of the full booster dose.
- Phase II and Phase III (Integrated)
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
- Aged 18 years and over, at the time of informed consent
- Capable of giving personal signed informed consent, which includes compliance with the require-ments listed in this protocol
- Born after 1974 and having received two doses of MVA-BN vaccination regimen at least one year after the second dose before being recruited
- Healthy participants who are determined by medical history and clinical judgment of the investiga-tor to be eligible for inclusion in the study. Healthy participants with pre-existing stable disease, de-fined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laborato-ry tests, and other study procedures
- Participants of childbearing potential (i.e. have a uterus and are neither surgically sterilized nor post-menopausal) must not be pregnant or breast-feeding. They should agree to a pregnancy test and use adequate contraception at least up to four weeks following the third vaccination of MVA-BN.
You likely can't join if
- History of previous smallpox vaccination or evidence of a vaccinia scar
- Planned pregnancy within four weeks after the injection (participants of childbearing potential)
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation (i.e. 7 months)
- Previous clinical or microbiological diagnosis of mpox
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention (chicken protein, benzonase, gentamicin and ciprofloxacin)
- Persons living with HIV and CD4-count <350 and/or detectable viral load at their most recent follow up at the outpatient clinic
See the full eligibility criteria
Who can join
- Aged 18 years and over, at the time of informed consent
- Capable of giving personal signed informed consent, which includes compliance with the require-ments listed in this protocol
- Born after 1974 and having received two doses of MVA-BN vaccination regimen at least one year after the second dose before being recruited
- Healthy participants who are determined by medical history and clinical judgment of the investiga-tor to be eligible for inclusion in the study. Healthy participants with pre-existing stable disease, de-fined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included
- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laborato-ry tests, and other study procedures
- Participants of childbearing potential (i.e. have a uterus and are neither surgically sterilized nor post-menopausal) must not be pregnant or breast-feeding. They should agree to a pregnancy test and use adequate contraception at least up to four weeks following the third vaccination of MVA-BN.
What rules you out
- History of previous smallpox vaccination or evidence of a vaccinia scar
- Planned pregnancy within four weeks after the injection (participants of childbearing potential)
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation (i.e. 7 months)
- Previous clinical or microbiological diagnosis of mpox
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention (chicken protein, benzonase, gentamicin and ciprofloxacin)
- Persons living with HIV and CD4-count <350 and/or detectable viral load at their most recent follow up at the outpatient clinic
- Immunosuppressed individuals with known or suspected immunodeficiency, as determined by histo-ry
- Individuals with a history of autoimmune disease or an active autoimmune disease, except for type 1 diabetes mellitus and auto-immune diseases of the skin or thyroid that do not require systemic immunosuppression
- Receipt of systemic corticosteroids withing one month before the study intervention
- Any physical or psychiatric illness or conditions that could threaten or compromise the health of the participant during the study, influence their ability to participate in the trial or interfere with the interpretation of the study results, as determined by the trial physician
- Pregnancy or breastfeeding (participants of childbearing potential)
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, 18-64 years, 65+ 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.