NCT07399951

Washington University WU 409: Immune Responses to Rabies Vaccine.

WU 409: Immune Responses to Rabies Vaccine in the Presence and Absence of Neutralizing Antibodies

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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). RANDOMIZATION PROCEDURES Participants will be randomized 1:1 to either: Arm-1 Imovax or RabAvert- 2 doses 7 days apart or Arm-2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0 Once 20 participants are enrolled to arms 1 and 2 10 more participants will be enrolled to: Arm-3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28 We plan to enroll 30 evaluable participants in the coming year, anticipating up to 30 enrolling in the optional FNA and BMA assessments

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Imovax	Rabies Vaccine
DRUG	RabAvert	Rabies Vaccine
DRUG	HyperRAB	rabies immune globulin (human)

Timeline

• Start date: 2023-07-18
• Primary completion: 2025-05-27
• Completion: 2025-10-01
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study