Boostability and safety of the single-visit rabies pre-exposure vaccination in adults.
Boostability of One-visit Rabies IntraDermal vaccination (BORID): A clinical trial evaluating the boostability and safety of a single-visit rabies pre-exposure prophylaxis schedules in adults.
The University of Queensland
200 participants
Mar 2, 2026
Interventional
Conditions
Summary
This study is testing a new, more convenient way to administer rabies pre-exposure vaccination in adults at risk. Instead of needing two visits to complete the vaccine course, three of the study schedules give the vaccine doses in a single visit: (1) one dose into the skin (intradermal), (2) two doses into the skin (in two injections sites), and (3) one dose into the muscle (intramuscular) in a single-visit, and this is compared with the current standard two-visit schedule: (4) two dosis into the muscle (one dose in each visit). The main aim is to determine whether this single-visit schedule “primes” the immune system sufficiently so that, when people later receive a booster dose, they quickly develop high levels of protective antibodies (“boostability”). To assess the "boostability" of the pre-exposure schedules, all participants will undergo a standard simulated post-exposure prophylaxis regimen with two doses administered intramuscularly (one dose per visit), approximately 56 days after receiving their initial pre-exposure vaccination. The study will also closely monitor and compare any side effects between the different schedules. The researchers hypothesise that the single-visit intradermal schedule will be as effective as the standard schedule in preparing the immune system, while being easier to complete and potentially reducing costs and barriers to protection.
Eligibility
Inclusion Criteria5
- Participants will be eligible for enrolment if they meet all of the following criteria
- Adults aged 18 years or older at the time of consent;
- In good general health as determined by the investigator (i.e., with no clinically significant acute or chronic disease, or condition that could interfere with study participation or outcomes);
- Able and willing to comply with all study visits, procedures, and follow-up requirements;
- Able to provide written informed consent.
Exclusion Criteria11
- Participants will be excluded if they meet any of the following criteria
- Prior receipt of any rabies vaccine, including PrEP or PEP vaccination;
- Plans to travel to rabies-endemic or high-risk regions during the study period;
- Individuals who require IM PrEP (e.g., laboratory workers who work with live lyssaviruses);
- Immunocompromised patients or with autoimmune disorders;
- Current or planned use of immunosuppressive or immunomodulator medications that may impair normal immune function;
- Receipt of blood products or immunoglobulins within the preceding 3 months;
- Pregnancy, breastfeeding, or intention to become pregnant during the study period;
- Known hypersensitivity or allergy to any component of Verorab;
- Contraindication to Verorab (e.g., history of mammalian meat allergy);
- Presence of an acute febrile illness or concurrent infectious disease at the time of enrolment.
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Interventions
Product: Verorab® (Inactivated rabies virus vaccine, Sanofi-Aventis Australia). Participants will be randomised (1:1:1:1) to one of four pre-exposure prophylaxis (PrEP) schedules, either intradermal (ID) or intramuscular (IM): 1. Experimental schedule 1: Single ID dose - 1 × 0.1 mL ID administered on Day 0 2. Experimental schedule 2: 2-site ID dose - 2 × 0.1 mL ID (two ID injections) administered sequentially on Day 0 3. Experimental schedule 3: Single IM dose - 1 × 0.5 mL IM administered on Day 0 To assess the boostability of the PrEP schedules, all participants will undergo a standard simulated post-exposure prophylaxis (PEP) regimen 56 ± 7 days after receiving their initial PrEP vaccination: - Day 56 ± 7: 1 × 0.5 mL IM; - Day 59 ± 7: 1 × 0.5 mL IM. The PrEP and PEP vaccines will be administered per protocol and recorded in the patient's medical record at the clinical trial site (Dr Deb The Travel Doctor clinic) and in the patient's immunisation records.
Locations(1)
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ACTRN12626000068369