Immunogenicity and safety of a fractional subcutaneous booster booster vaccination against mpox with MVA-BN: a randomised-controlled non-inferiority study (SUBO-trial)

Conditions

mpox (earlier: monkey pox)

Brief summary

Geometric mean concentrations (GMC) of VACV-specific antibodies (D0, D14)

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGIMVANEX suspension for injection Smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)

DRUGIMVANEX

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Geometric mean concentrations (GMC) of VACV-specific antibodies (D0, D14)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed