Healthy ParticipantsEarly Phase 1NCT07399951
Washington University WU 409: Immune Responses to Rabies Vaccine.
A Early Phase 1 study testing Imovax, RabAvert and HyperRAB in people with Healthy Participants, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Imovax, RabAvert and HyperRAB
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2023to 1 Oct 2025
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 5. 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
Who cannot join
- 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.
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- 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.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine Infectious Disease Clinical Trials Unit.
St Louis, Missouri, 63110
About this study
Official title: WU 409: Immune Responses to Rabies Vaccine in the Presence and Absence of Neutralizing Antibodies
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).
Read the 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
- Being tested
- Imovax, RabAvert, HyperRAB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImovaxDrug
Rabies Vaccine
RabAvertDrug
Also called RabAver
Rabies Vaccine
HyperRABDrug
rabies immune globulin (human)
| Study group | Role | What they receive |
|---|---|---|
| Arm-1 Imovax or RabAvert- 2 doses 7 days apart | Experimental | Imovax or RabAvert- 2 doses 7 days apart Receives: 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 Receives: 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 Receives: Drug: Imovax; Drug: RabAvert; Drug: HyperRAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing Antibody Titers at D28
Neutralizing Rabies Virus Antibody Titers at D28
Measured: 28 days
Comparison of Antibody Titers at D365 Versus Baseline
Comparison of participant Neutralizing Rabies Virus Antibody titers at D365 versus baseline
Measured: 365 days
Secondary outcomes (1)
Frequency Serious Adverse Events
Number of serious adverse events reported
Measured: time of consent to day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start19 Oct 2023
- Primary completion24 Jun 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Presti, Washington University School of Medicine
- Investigators
- Rachel Presti, MD PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399951
- Sponsor's protocol ID
- 202305094
- Other IDs
- PJ000006488
- Status last verified
- Jul 2023
- First submitted
- 27 Jan 2026
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no statistical analysis plan as the study is an exploratory evaluation of how the immune system responds to different vaccines. There is no clinical study report as the intent of the study is IND exempt and not intended to support a change to the current marketing application approving the vaccines for use by the FDA and other regulatory agencies. The analytic code would be the software (SAS or R/Python) used for analyzing study data to support an application to a regulatory body.