Healthy Participants
Conditions
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).
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
Interventions
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- 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
Exclusion criteria
1. Receipt of prior rabies vaccination or risk for rabies exposure requiring standard vaccination 2. Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration. 9. 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. 10. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial. 11. Coagulopathy (primary or iatrogenic) which would contraindicate bone marrow aspirate or core lymph node biopsy for participants willing to have those procedures done 12. Known IgA deficiency, as this is a known risk factor for anaphylactic reactions to Rabies immunoglobulin. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of antibody titers at D28 versus baseline | 28 days | Comparison of antibody titers at D28 versus baseline |
| Comparison of antibody titers at D365 versus baseline | 365 days | Comparison of antibody titers at D365 versus baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency serious adverse events | time of consent to day 365 | Number of serious adverse events reported |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRachel Presti, MD PhD
Washington University School of Medicine
Outcome results
None listed