Trial Outcomes & Findings for Study of Intradermal Administration of PCEC Rabies Vaccine (NCT NCT01044199)
NCT ID: NCT01044199
Last Updated: 2026-06-24
Results Overview
Proportion of participants with rabies virus neutralizing antibody titers ≥1:5 (approximately 0.1 IU/mL) measured by rapid fluorescent focus inhibition test (RFFIT).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
Day 14 after completion of the vaccination regimen (Day 35 for Pre-Exposure groups and Day 14 for Booster groups)
Results posted on
2026-06-24
Participant Flow
Participant milestones
| Measure |
1: Pre-EP ID
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
2: Pre-EP IM
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
3: Booster ID
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
4: Booster IM
Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
31
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
1: Pre-EP ID
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
2: Pre-EP IM
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
3: Booster ID
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
4: Booster IM
Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
|---|---|---|---|---|
|
Overall Study
Excluded from immunological analysis
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Study of Intradermal Administration of PCEC Rabies Vaccine
Baseline characteristics by cohort
| Measure |
1: Pre-EP ID
n=33 Participants
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
2: Pre-EP IM
n=33 Participants
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
3: Booster ID
n=31 Participants
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
4: Booster IM
n=33 Participants
Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
33 Participants
n=6 Participants
|
130 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
36 years
n=20 Participants
|
40 years
n=20 Participants
|
44 years
n=40 Participants
|
43 years
n=6 Participants
|
43 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
20 Participants
n=6 Participants
|
69 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
13 Participants
n=6 Participants
|
61 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
31 Participants
n=6 Participants
|
125 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
29 Participants
n=6 Participants
|
118 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=20 Participants
|
33 participants
n=20 Participants
|
31 participants
n=40 Participants
|
33 participants
n=6 Participants
|
130 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 14 after completion of the vaccination regimen (Day 35 for Pre-Exposure groups and Day 14 for Booster groups)Population: All participants who completed the vaccination regimen.
Proportion of participants with rabies virus neutralizing antibody titers ≥1:5 (approximately 0.1 IU/mL) measured by rapid fluorescent focus inhibition test (RFFIT).
Outcome measures
| Measure |
1: Pre-EP ID
n=33 Participants
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
2: Pre-EP IM
n=33 Participants
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
3: Booster ID
n=31 Participants
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
4: Booster IM
n=33 Participants
Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
|---|---|---|---|---|
|
Number of Participants With Adequate Rabies Virus Neutralizing Antibody Titers
|
33 Participants
|
33 Participants
|
31 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Day 14 after vaccinationPopulation: All participants who completed the vaccination regimen were included in the analysis.
Geometric mean titers (GMTs) of rabies virus neutralizing antibodies measured by RFFIT at Day 14 after vaccination.
Outcome measures
| Measure |
1: Pre-EP ID
n=33 Participants
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
2: Pre-EP IM
n=33 Participants
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
3: Booster ID
n=31 Participants
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
4: Booster IM
n=33 Participants
Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Rabies Virus Neutralizing Antibodies
|
2.5 IU/ml
Interval 2.0 to 3.0
|
5.0 IU/ml
Interval 4.0 to 6.0
|
15 IU/ml
Interval 12.0 to 18.0
|
30 IU/ml
Interval 25.0 to 35.0
|
Adverse Events
1: Pre-EP ID
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
2: Pre-EP IM
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
3: Booster ID
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
4: Booster IM
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1: Pre-EP ID
n=33 participants at risk
Group of participants receiving PCEC rabies vaccine intradermally with the Pre-Exposure schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
2: Pre-EP IM
n=33 participants at risk
Group of participants receiving PCEC rabies vaccine intramuscular with the Pre-Exposure schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
3: Booster ID
n=31 participants at risk
Group of participants receiving PCEC rabies vaccine intradermally with the Booster schedule.
PCEC rabies vaccine given intradermally: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
4: Booster IM
n=33 participants at risk
Group of participants receiving PCEC rabies vaccine intramuscular with the Booster schedule.
PCEC rabies vaccine administered intramuscularly: PCEC rabies vaccine will be given intradermally compared with intramuscular administration (standard), in 2 different schedules: Pre-Exposure schedule for participants never vaccinated against rabies before; and Booster schedule for participants vaccinated against rabies in the past.
|
|---|---|---|---|---|
|
General disorders
Erythema
|
75.8%
25/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
15.2%
5/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
83.9%
26/31 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
15.2%
5/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
|
General disorders
Induration
|
6.1%
2/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
57.6%
19/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
29.0%
9/31 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
48.5%
16/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
|
Nervous system disorders
Headache
|
27.3%
9/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
15.2%
5/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
12.9%
4/31 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
30.3%
10/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
|
General disorders
Fatigue
|
12.1%
4/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
21.2%
7/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
16.1%
5/31 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
24.2%
8/33 • From vaccination through final study follow-up, approximately 6 months
Adverse events were assessed after vaccination and during follow-up visits. Participants recorded systemic and local adverse events for 7 days after vaccination.
|
Additional Information
Sergio Recuenco, MD, PhD
Centers for Disease Control and Prevention
Phone: (404) 639-0802
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place