RABIES VIRUS (INACTIVATED) for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- Healthy participant\n- Age 18-55 year\n- Signed written Informed Consent\n- Willingness and ability to adhere to the study regimen\n- Naïve for tuberculosis, i.e. a negative QuantiFERON® -TB Gold In-Tube test result according to the manufacturer’s specifications at screening.\n- Negative for HIV, i.e. a negative HIV test at screening."}

Exclusion criteria

• {"criterion_text":"- History of TB disease or treatment\n- Positive pregnancy test at screening or at month 6 (before 2nd vaccination)\n- Women of child bearing potential not willing to use contraceptives during the study, or if breastfeeding\n- History of keloid formation\n- Active participation in other clinical trials\n- Does not consent to us informing the participant’s General Practitioner of the BCG vaccination and of any uncommon, rare or serious adverse events\n- Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial\n- BCG or Rabies vaccination at any time prior to entering the trial (through taking medical history, presence of typical BCG scar or vaccination card)\n- Live vaccination (measles, mumps, rubella, oral polio, oral typhoid or yellow fever) 4 weeks or less prior to the BCG vaccination\n- Treatment with immune modulating drugs (e.g. systemic steroids, azathioprine, cyclosporine, anti-TNFα, immunoglobulines, cytostatics) 6 months or less prior to enrollment\n- (History of) disease affecting the lymphoid organs (e.g. Hodgkin’s disease, lymphoma, leukemia, sarcoidosis)\n- Known congenital or acquired immune deficiencies\n- Positive HIV test result at screening\n- Fever or antibiotic treatment 2 weeks or less prior to enrollment\n- Known hypersensitivity to any of the vaccine’s components"}

Primary endpoints

• {"endpoint_text":"- Induction of mycobacterial growth control measured in vitro by MGIA (1 log reduction post vaccination compared to inoculum). Level of control in MGIA will be used as classifier to assess pre-vaccination functional status.","definition_or_measurement_approach":"Measured in vitro by MGIA (mycobacterial growth inhibition assay); defined as 1 log reduction post vaccination compared to inoculum; level of control in MGIA used as classifier of pre-vaccination functional status."}

Secondary endpoints

• {"endpoint_text":"- Imaging of dermal biopsies and correlation of relative subset distribution with functional mycobacterial growth control in MGIA. Frequencies of subsets in the dermis will be correlated with MGIA control capacity.","definition_or_measurement_approach":"Imaging of dermal biopsies to determine relative subset distribution; correlate frequencies of dermal subsets with MGIA control capacity."}
• {"endpoint_text":"- Correlates of protection for both BCG (MGIA as best available correlate) and Rabipur (neutralizing antibodies) vaccinations will be compared and correlated.","definition_or_measurement_approach":"Compare and correlate MGIA (for BCG) and neutralizing antibody measurements (for Rabipur) as correlates of protection."}
• {"endpoint_text":"- Correlation between cell frequencies and functional read outs prevaccination and at multiple post vaccination time points","definition_or_measurement_approach":"Measure cell frequencies and functional readouts at baseline and multiple post-vaccination time points and assess correlations."}
• {"endpoint_text":"- Correlation of metabolic state to effector immune responses such as measured by MGIA and intracellular cytokine secretion.","definition_or_measurement_approach":"Assess immune cell metabolic state (e.g. by Scenith) and correlate with effector responses measured by MGIA and intracellular cytokine secretion assays."}

Methods

• Recruitment procedure document (K1_Recruitment procedure NL 2024-514428-18-00 Clean) — formal recruitment procedure document (country: Netherlands).
• Poster (K2_Poster 2024-514428-18-00 NL) — channel: poster; target audience: healthy volunteers; country: Netherlands.
• Website text (K2_text website VP 2024-514428-18-00 NL) — channel: website; target audience: healthy volunteers; country: Netherlands.
• Slides/info film (K2_Slides info filmpje 2024-514428-18-00 NL) — channel: informational slides/video for potential participants; country: Netherlands.

Netherlands

Latest Decision Or Authorization Date

21-07-2025

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands