2024-510697-24-00招募中3 期
Immunogenicity and safety of a fractional subcutaneous booster booster vaccination against mpox with MVA-BN: a randomised-controlled non-inferiority study (SUBO-trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Geometric mean concentrations (GMC) of VACV-specific antibodies (D0, D14)
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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)
结局指标
主要结局
Geometric mean concentrations (GMC) of VACV-specific antibodies (D0, D14)
Geometric mean concentrations (GMC) of VACV-specific antibodies (D0, D14)
次要结局
- GMC of antibodies against VACV (M6), MVA-BN and MPXV (D0, D14 and M6)
- Seroconversion for neutralizing antibodies in a subgroup of participants to VACV, MVA-BN, and MPXV (D0, D14, M6)
- GMT for neutralizing antibodies in a subgroup of participants to VACV, MVA-BN, and MPXV (D0, D14, M6)
- Percentages of MPXV- and VACV-specific T cells in a subgroup of participants
- Number of spot forming unit per million cells (IFN-g ELISpot) upon stimulation with peptide gen-erated using VACV sequences
- Percentages of activated T cells following peptide stimulation
- Self-reported local and systemic reactions over a 7-day period, or until symptom remission, using an (electronical) diary and control visits at day 14 and month 6 months after booster vaccination
- Adverse events (AEs) until one week after vaccination or until symptom remission, using an (electronical) diary and control visits at day 14 and month 6 months after booster vaccination
- Serious AEs (SAEs) until six months after vaccination
研究者
Leo Visser
Scientific
Academisch Ziekenhuis Leiden
研究点 (3)
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