Washington University WU 409: Immune Responses to Rabies Vaccine.

NCT07399951 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 202305094PJ000006488
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• Comparison of antibody titers at D28 versus baseline

  Comparison of antibody titers at D28 versus baseline

  28 days

• Comparison of antibody titers at D365 versus baseline

  Comparison of antibody titers at D365 versus baseline

  365 days

Secondary Outcomes (1)

• Frequency serious adverse events

  time of consent to day 365

Study Arms (3)

Arm-1 Imovax or RabAvert- 2 doses 7 days apart

EXPERIMENTAL

Imovax or RabAvert- 2 doses 7 days apart

Drug: Imovax; Drug: RabAvert

Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0

EXPERIMENTAL

Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0

Drug: Imovax; Drug: RabAvert; Drug: HyperRAB

Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28

EXPERIMENTAL

Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28

Drug: Imovax; Drug: RabAvert; Drug: HyperRAB

Interventions

Imovax DRUG

Rabies Vaccine

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

RabAvert DRUG

Rabies Vaccine

Also known as: RabAver

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

HyperRAB DRUG

rabies immune globulin (human)

Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0; Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Healthy participants over 18 years of age. 2. Able to understand and give informed consent. 3. Willing to receive rabies vaccine 4. In stable health, as determined by medical history and targeted physical exam related to this history.
• \. For those willing to give FNA, CBL and BMA samples, Willing to: give FNA specimens OR give CBL specimens OR give bone marrow aspirates OR give both FNA and BMA specimens OR give both FNA and CBL specimens OR give FNA, CBL and BMA specimens

You may not qualify if:

• Receipt of prior rabies vaccination or risk for rabies exposure requiring standard vaccination
• Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
• Has received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
• Is acutely ill or febrile (temperature \>38.0 C \[100.4F\] less than 72 hours prior to or at the day 1 visit. Participants who meet this criteria may be rescheduled.
• Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.
• History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
• Has received any vaccine ≤ 28 days prior to the injection (Day 1) or plans to receive a vaccine within 28 days before or after the study injection. These participants may be rescheduled.
• Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
• Have donated blood, blood products or bone marrow within 30 days before study vaccination, plan to donate blood at any time during the duration of participant study participation, or plan to donate blood within 30 days after the last blood draw.
• Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
• Coagulopathy (primary or iatrogenic) which would contraindicate bone marrow aspirate or core lymph node biopsy for participants willing to have those procedures done
• Known IgA deficiency, as this is a known risk factor for anaphylactic reactions to Rabies immunoglobulin.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine Infectious Disease Clinical Trials Unit.

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

Rabies Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Rachel Presti, MD PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Medicine, Division of Infectious Disease Washington University, St. Louis, MO

Model Details: 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 5 participants are enrolled to arms 1 and 2 participants will be randomized 1:3 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 Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28 TO 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

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 10, 2026
• Study Start: July 18, 2023
• Primary Completion: May 27, 2025
• Study Completion: October 1, 2025
• Last Updated: February 10, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: ICF is attached Protocol is attached CSR within 30 days of completion.
• Access Criteria: ICF is attached Protocol is attached

Locations

US (1)