Trial Outcomes & Findings for Simplifying the Rabies Pre-exposure Vaccination (NCT NCT01388985)
NCT ID: NCT01388985
Last Updated: 2019-05-14
Results Overview
The primary endpoint is the number of particpants with a boostability of the rabies antibodies on day 7 after booster vaccination, carried out at years 1 to 3 after initial vaccination. A rabies serology value of more than 0,5 IU/ml (international unit/milliliter) on day 7 after booster vaccination is considered to be protective. Subjects showing this serology value at day 7 are considered to be boostable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
500 participants
Primary outcome timeframe
Day 7 after booster vaccination
Results posted on
2019-05-14
Participant Flow
2 participants (1 in each group) signed the ICF and were randomized, but withdrew their consent before the first vaccination. They are not included in any of the analyses.
Participant milestones
| Measure |
Standard Vaccination Schedule
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
249
|
|
Overall Study
Primary Vaccination Period
|
231
|
238
|
|
Overall Study
COMPLETED
|
200
|
211
|
|
Overall Study
NOT COMPLETED
|
49
|
38
|
Reasons for withdrawal
| Measure |
Standard Vaccination Schedule
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
30
|
30
|
|
Overall Study
Withdrawal by Subject
|
13
|
4
|
|
Overall Study
Subject unavailable
|
1
|
1
|
|
Overall Study
Other (no reason)
|
0
|
1
|
|
Overall Study
Error of nurse
|
5
|
1
|
Baseline Characteristics
Simplifying the Rabies Pre-exposure Vaccination
Baseline characteristics by cohort
| Measure |
Standard Vaccination Schedule
n=249 Participants
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
n=249 Participants
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Total
n=498 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
28 years
n=7 Participants
|
29 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
237 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
|
Serology at baseline
0.5 IU/mL or less
|
245 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
493 Participants
n=5 Participants
|
|
Serology at baseline
more than 0.5 IU/mL
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7 after booster vaccinationPopulation: From the total number of participants that completed the study (200 in the standard vaccination schedule and 211 in het accelerated vaccination schedule), not all were included in het per protocol analysis. 15 participants were excluded from the standard vaccination schedule group and 28 were excluded from the accelerated schedule group.
The primary endpoint is the number of particpants with a boostability of the rabies antibodies on day 7 after booster vaccination, carried out at years 1 to 3 after initial vaccination. A rabies serology value of more than 0,5 IU/ml (international unit/milliliter) on day 7 after booster vaccination is considered to be protective. Subjects showing this serology value at day 7 are considered to be boostable.
Outcome measures
| Measure |
Standard Vaccination Schedule
n=185 Participants
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
n=183 Participants
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
|---|---|---|
|
Number of Participants With a Boostability of the Rabies Antibodies After Booster Vaccination
|
185 Participants
|
183 Participants
|
SECONDARY outcome
Timeframe: Day 35 after primary (initial) vaccinationNumber of participants that have a Rabies serology more than 0,5 IU/ml on day 35 after primary vaccination.
Outcome measures
| Measure |
Standard Vaccination Schedule
n=231 Participants
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
n=238 Participants
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
|---|---|---|
|
Number of Participants With a Rabies Serology More Than 0.5IU/ml After Primary Vaccination
|
231 Participants
|
238 Participants
|
SECONDARY outcome
Timeframe: Day 35 after primary (initial) vaccination, and after booster vaccinationNumber of participants that have a Rabies serology more than 10 IU/ml on day 35 after primary vaccination, and after booster vaccination.
Outcome measures
| Measure |
Standard Vaccination Schedule
n=231 Participants
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
n=238 Participants
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
|---|---|---|
|
Number of Particpants With a Rabies Serology More Than 10IU/ml After Primary and Booster Vaccination
|
189 Participants
|
167 Participants
|
SECONDARY outcome
Timeframe: One week after initial and booster vaccinationNumber of participants experiencing Adverse events within one week after initial and booster vaccinations
Outcome measures
| Measure |
Standard Vaccination Schedule
n=249 Participants
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
n=249 Participants
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
|---|---|---|
|
Number of Particpants Experiencing Adverse Events
|
190 Participants
|
190 Participants
|
SECONDARY outcome
Timeframe: 28 days after initial and booster vaccinationNumber of participants experiencing a Serious adverse event within 28 days after initial and booster vaccinations
Outcome measures
| Measure |
Standard Vaccination Schedule
n=249 Participants
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
n=249 Participants
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events
|
1 Participants
|
2 Participants
|
Adverse Events
Standard Vaccination Schedule
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Accelerated Vaccination Schedule
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard Vaccination Schedule
n=249 participants at risk
One injection will be given on three different days (day 0, day 7 and day 21 or 28)
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
Accelerated Vaccination Schedule
n=249 participants at risk
Two injections will be given on the same day (day 0 and day 7): one on each forearm.
Human Diploid Cell Vaccine (HDCV) rabies vaccine: Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
0.40%
1/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
|
Nervous system disorders
Hemianopia
|
0.40%
1/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
0.00%
0/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
|
Eye disorders
Diplopia
|
0.40%
1/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
0.00%
0/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
0.40%
1/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
0.40%
1/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
0.80%
2/249 • Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Patrick Soentjens
Institute of Tropical Medicine Antwerp
Phone: +32 3 247 66 41
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place