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Trial record 12 of 77 for:    "Rabies" | "Immunologic Factors"

Simplifying the Rabies Pre-exposure Vaccination

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ClinicalTrials.gov Identifier: NCT01388985
Recruitment Status : Completed
First Posted : July 7, 2011
Results First Posted : March 6, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
Military Hospital, Brussels
Sciensano
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Rabies
Intervention Biological: Human Diploid Cell Vaccine (HDCV) rabies vaccine
Enrollment 500
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Standard Vaccination Schedule Accelerated Vaccination Schedule
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 249 [1] 249 [1]
Primary Vaccination Period 231 238
Completed 200 [2] 211 [3]
Not Completed 49 38
Reason Not Completed
Death             0             1
Lost to Follow-up             30             30
Withdrawal by Subject             13             4
Subject unavailable             1             1
Other (no reason)             0             1
Error of nurse             5             1
[1]
1 participant (from the 250 enrolled) did not receive any vaccination because of consent withdrawal.
[2]
From those 200, 15 were excluded from the per protocol analysis.
[3]
From those 200, 28 were excluded from the per protocol analysis.
Arm/Group Title Standard Vaccination Schedule Accelerated Vaccination Schedule Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 249 249 498
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 249 participants 249 participants 498 participants
29
(24 to 35)
28
(23 to 34)
29
(23 to 35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 249 participants 498 participants
Female
12
   4.8%
8
   3.2%
20
   4.0%
Male
237
  95.2%
241
  96.8%
478
  96.0%
Serology at baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 249 participants 498 participants
0.5 IU/mL or less
245
  98.4%
248
  99.6%
493
  99.0%
more than 0.5 IU/mL
4
   1.6%
1
   0.4%
5
   1.0%
1.Primary Outcome
Title Number of Participants With a Boostability of the Rabies Antibodies After Booster Vaccination
Hide Description 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.
Time Frame Day 7 after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Standard Vaccination Schedule Accelerated Vaccination Schedule
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 185 183
Measure Type: Count of Participants
Unit of Measure: Participants
185
 100.0%
183
 100.0%
2.Secondary Outcome
Title Number of Participants With a Rabies Serology More Than 0.5IU/ml After Primary Vaccination
Hide Description Number of participants that have a Rabies serology more than 0,5 IU/ml on day 35 after primary vaccination.
Time Frame Day 35 after primary (initial) vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Vaccination Schedule Accelerated Vaccination Schedule
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 231 238
Measure Type: Count of Participants
Unit of Measure: Participants
231
 100.0%
238
 100.0%
3.Secondary Outcome
Title Number of Particpants With a Rabies Serology More Than 10IU/ml After Primary and Booster Vaccination
Hide Description Number of participants that have a Rabies serology more than 10 IU/ml on day 35 after primary vaccination, and after booster vaccination.
Time Frame Day 35 after primary (initial) vaccination, and after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Vaccination Schedule Accelerated Vaccination Schedule
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 231 238
Measure Type: Count of Participants
Unit of Measure: Participants
189
  81.8%
167
  70.2%
4.Secondary Outcome
Title Number of Particpants Experiencing Adverse Events
Hide Description Number of participants experiencing Adverse events within one week after initial and booster vaccinations
Time Frame One week after initial and booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Vaccination Schedule Accelerated Vaccination Schedule
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 249 249
Measure Type: Count of Participants
Unit of Measure: Participants
190
  76.3%
190
  76.3%
5.Secondary Outcome
Title Number of Participants Experiencing Serious Adverse Events
Hide Description Number of participants experiencing a Serious adverse event within 28 days after initial and booster vaccinations
Time Frame 28 days after initial and booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Vaccination Schedule Accelerated Vaccination Schedule
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 249 249
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.4%
2
   0.8%
Time Frame Adverse events are collected until 1 week after the vaccination. Serious adverse events (SAEs) are collected until 28 days after the vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Vaccination Schedule Accelerated Vaccination Schedule
Hide Arm/Group Description

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

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

All-Cause Mortality
Standard Vaccination Schedule Accelerated Vaccination Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/249 (0.00%)   1/249 (0.40%) 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Vaccination Schedule Accelerated Vaccination Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   1/249 (0.40%)   2/249 (0.80%) 
Eye disorders     
Diplopia  1/249 (0.40%)  0/249 (0.00%) 
Gastrointestinal disorders     
Oesophagitis  0/249 (0.00%)  1/249 (0.40%) 
Nervous system disorders     
Hemianopia  1/249 (0.40%)  0/249 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  0/249 (0.00%)  1/249 (0.40%) 
Skin and subcutaneous tissue disorders     
Angioedema  0/249 (0.00%)  1/249 (0.40%) 
Urticaria  0/249 (0.00%)  2/249 (0.80%) 
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Vaccination Schedule Accelerated Vaccination Schedule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/249 (0.00%)   0/249 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Patrick Soentjens
Organization: Institute of Tropical Medicine Antwerp
Phone: +32 3 247 66 41
Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT01388985     History of Changes
Other Study ID Numbers: ITMC0211
2011-001612-62 ( EudraCT Number )
First Submitted: July 5, 2011
First Posted: July 7, 2011
Results First Submitted: October 16, 2018
Results First Posted: March 6, 2019
Last Update Posted: May 14, 2019