Trial Outcomes & Findings for Washington University WU 409: Immune Responses to Rabies Vaccine. (NCT NCT07399951)
NCT ID: NCT07399951
Last Updated: 2026-07-02
Results Overview
Neutralizing Rabies Virus Antibody Titers at D28
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
31 participants
Primary outcome timeframe
28 days
Results posted on
2026-07-02
Participant Flow
The first participant was consented 19 OCT 2023 Study procedures were conducted at the Wahsington University Infectious Disease Clinical Research Unit. Participants were recruited from Registry and Word of Mouth. Recruitment stopped 19 June 2024. The last study activity was 24 June 2025
Participant milestones
| Measure |
Imovax or RabAvert- 2 Doses 7 Days Apart
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 0
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 28.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Imovax or RabAvert- 2 Doses 7 Days Apart
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 0
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 28.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
Baseline Characteristics
Washington University WU 409: Immune Responses to Rabies Vaccine.
Baseline characteristics by cohort
| Measure |
Imovax or RabAvert- 2 Doses 7 Days Apart
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 0
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
n=9 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 28.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
27 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=29 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
19 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
10 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
5 Participants
n=9 Participants
|
21 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
27 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=29 Participants
|
|
Neutralizing Antibody Titer day 0
|
0.2 International Units per milliliter
STANDARD_DEVIATION 0 • n=10 Participants
|
0.2 International Units per milliliter
STANDARD_DEVIATION 0 • n=10 Participants
|
0.2 International Units per milliliter
STANDARD_DEVIATION 0 • n=9 Participants
|
0.2 International Units per milliliter
STANDARD_DEVIATION 0 • n=29 Participants
|
PRIMARY outcome
Timeframe: 28 daysNeutralizing Rabies Virus Antibody Titers at D28
Outcome measures
| Measure |
Imovax or RabAvert- 2 Doses 7 Days Apart
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 0
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
n=9 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 28.
|
|---|---|---|---|
|
Neutralizing Antibody Titers at D28
|
2.263333334 IU/ml per ml serum
Standard Deviation 1.644628367
|
1.130000002 IU/ml per ml serum
Standard Deviation 1.528854167
|
2.8416666667 IU/ml per ml serum
Standard Deviation 3.966536334
|
PRIMARY outcome
Timeframe: 365 daysComparison of participant Neutralizing Rabies Virus Antibody titers at D365 versus baseline
Outcome measures
| Measure |
Imovax or RabAvert- 2 Doses 7 Days Apart
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 0
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 28.
|
|---|---|---|---|
|
Comparison of Antibody Titers at D365 Versus Baseline
|
0.306666667 IU/ml
Standard Deviation 0.247356391
|
1.130000002 IU/ml
Standard Deviation 0.811065447
|
2.841666667 IU/ml
Standard Deviation 0.523096195
|
SECONDARY outcome
Timeframe: time of consent to day 365Number of serious adverse events reported
Outcome measures
| Measure |
Imovax or RabAvert- 2 Doses 7 Days Apart
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 0
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
n=10 Participants
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 28.
|
|---|---|---|---|
|
Frequency Serious Adverse Events
|
0 Adverse events
|
0 Adverse events
|
1 Adverse events
|
Adverse Events
Imovax or RabAvert- 2 Doses 7 Days Apart
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imovax or RabAvert- 2 Doses 7 Days Apart
n=11 participants at risk
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
n=10 participants at risk
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 0
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
n=10 participants at risk
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 28.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with spontaneous abortion
|
0.00%
0/11 • from enrollment until end of follow-up, up to day 366
|
0.00%
0/10 • from enrollment until end of follow-up, up to day 366
|
10.0%
1/10 • from enrollment until end of follow-up, up to day 366
|
Other adverse events
| Measure |
Imovax or RabAvert- 2 Doses 7 Days Apart
n=11 participants at risk
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 0
n=10 participants at risk
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 0
|
Imovax or RabAvert- 2 Doses 7 Days Apart With Rabies Immune Globulin at Day 28
n=10 participants at risk
Two 1.0 mL doses of Imovax or RabAvert Rabies vaccine administered intramuscularly: 1 injection on Day 0, and 1 on Day 7 One dose (20 IU/kg body weight) administered intramuscularly on Day 28.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergic skin reaction
|
9.1%
1/11 • from enrollment until end of follow-up, up to day 366
|
0.00%
0/10 • from enrollment until end of follow-up, up to day 366
|
0.00%
0/10 • from enrollment until end of follow-up, up to day 366
|
Additional Information
Rachel Presti, MD, PhD
Washington University School of Medicine Infectious Disease P.O. Box 8051 660 South Euclid Avenue St. Louis, MO 63110
Phone: (314) 286-0345
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place