Washington University WU 409: Immune Responses to Rabies Vaccine.

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07399951
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Imovax — DRUG
    Rabies Vaccine
  • RabAvert — DRUG
    Rabies Vaccine
  • HyperRAB — DRUG
    rabies immune globulin (human)

Study Details

This study will evaluate the immune response to rabies vaccination persons 18 years and older. We will evaluate thirty healthy participants across three cohorts: 1) standard rabies pre-exposure prophylaxis regimen (two doses of Imovax® or RabAvert® seven days apart with no RIG); 2) rabies pre-exposure prophylaxis regimen + day 0 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 0); 3) rabies pre-exposure prophylaxis regimen + day 28 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 28).

Key Dates

Start date
Jul 18, 2023
Status verified
Jul 2023
Primary completion
May 27, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm-1 Imovax or RabAvert- 2 doses 7 days apart
    Imovax or RabAvert- 2 doses 7 days apart
  • Experimental: Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
    Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
  • Experimental: Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28
    Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28

Primary Outcome Measure

Comparison of antibody titers at D28 versus baseline [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine Infectious Disease Clinical Trials Unit.St LouisMissouri63110-

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Washington University School of Medicine Infectious Disease Clinical Trials Unit.· St Louis, MO

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