Ended Therapeutic confirmatory (Phase III) Rabies

A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal and intramuscular rabies vaccination < RABISKIMM >

EU CTIS ID: 2023-507065-26-00

What this study is testing

To compare the number and proportion of skin-resident memory T cells against RABV (RABV-TRM) after booster dose by vaccination route.

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

MAIN + PILOT + HEALTHY CONTROL GROUP: >/=18 to ≤50 years of age
PILOT: should have had a completed or partly completed schedule of rabies vaccination more than one month prior to recruitment
PILOT: BMI ≤30 kg/m2
PILOT: Able and willing to provide written informed consent
PILOT: No acute illness at time of recruitment
MAIN + PILOT: Willing to use contraception during the course of the trial (for women of childbearing potential)

You likely can't join if

MAIN + PILOT: Subjects who received a rabies vaccination prior to recruitment (including a single dose)
MAIN + PILOT: Pregnancy or planning to become pregnant during the course of the trial
MAIN + PILOT + HEALTHY CONTROL GROUP: Subjects who received PEP (or immunoglobulines)
MAIN + PILOT: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment
MAIN + PILOT: Active participation in another interventional clinical study with active substance intake during the trial or 1 month prior to recruitment
MAIN + PILOT: Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months prior to recruitment, except topical or short-term oral steroids.

See the full eligibility criteria

Who can join

MAIN + PILOT + HEALTHY CONTROL GROUP: >/=18 to ≤50 years of age
PILOT: should have had a completed or partly completed schedule of rabies vaccination more than one month prior to recruitment
PILOT: BMI ≤30 kg/m2
PILOT: Able and willing to provide written informed consent
PILOT: No acute illness at time of recruitment
MAIN + PILOT: Willing to use contraception during the course of the trial (for women of childbearing potential)
PILOT: Not pregnant or planning to become pregnant during the course of the trial
HEALTHY CONTROL GROUP: Able and willing to provide written informed consent
HEALTHY CONTROL GROUP: Agreement to share and discuss participant’s medical history and medical records when relevant
HEALTHY CONTROL GROUP: No acute illness at time of recruitment
MAIN: BMI ≤30 kg/m2
MAIN: Agreement to refrain from blood donation and other vaccinations 30 days following each vaccination
MAIN: Agreement to share and discuss participant’s medical history and medical records when relevant
MAIN: Able and willing to provide written informed consent

What rules you out

MAIN + PILOT: Subjects who received a rabies vaccination prior to recruitment (including a single dose)
MAIN + PILOT: Pregnancy or planning to become pregnant during the course of the trial
MAIN + PILOT + HEALTHY CONTROL GROUP: Subjects who received PEP (or immunoglobulines)
MAIN + PILOT: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment
MAIN + PILOT: Active participation in another interventional clinical study with active substance intake during the trial or 1 month prior to recruitment
MAIN + PILOT: Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months prior to recruitment, except topical or short-term oral steroids.
MAIN + PILOT: Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
MAIN + PILOT: History of anaphylaxis, allergic disease or reactions to any component of the study vaccines
HEALTHY CONTROL GROUP: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment.
MAIN + PILOT : Tendency to keloid (scar) formation in response to skin damage
MAIN + PILOT + HEALTHY CONTROL GROUP: Skin diseases at the biopsy and vaccination site
MAIN + PILOT: History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
MAIN + PILOT: Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data
HEALTHY CONTROL GROUP: Subjects who received a rabies vaccination prior to recruitment (including a single dose)
HEALTHY CONTROL GROUP: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment
HEALTHY CONTROL GROUP: Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short-term oral steroids.
HEALTHY CONTROL GROUP: Any other significant disease, disorder, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data
HEALTHY CONTROL GROUP: Suspected or known alcohol or drug dependency
MAIN + PILOT: Suspected or known alcohol or drug dependency

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. 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.