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Trial record 1 of 1 for:    H-040-008
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A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

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ClinicalTrials.gov Identifier: NCT00319592
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : August 16, 2012
Last Update Posted : August 20, 2012
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Interventions Biological: ChimeriVax™-JE vaccine
Biological: JE-VAX® vaccine
Enrollment 60
Recruitment Details Participants were enrolled from 18 May 2005 to 07 September 2005 at 1clinical center in the United States.
Pre-assignment Details A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title ChimeriVax™-JE After Placebo JE-VAX®
Hide Arm/Group Description Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28. Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
Period Title: Overall Study
Started 30 30
Completed 29 29
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             0
Physician Decision             0             1
Arm/Group Title ChimeriVax™-JE After Placebo JE-VAX® Total
Hide Arm/Group Description Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28. Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
32.7  (8.82) 29.2  (9.14) 31  (8.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
16
  53.3%
16
  53.3%
32
  53.3%
Male
14
  46.7%
14
  46.7%
28
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine
Hide Description Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.
Time Frame Day 0 (pre-vaccination) and up to Day 56 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).
Arm/Group Title ChimeriVax™-JE After Placebo JE-VAX®
Hide Arm/Group Description:
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
Overall Number of Participants Analyzed 29 26
Measure Type: Number
Unit of Measure: Participants
Day 14 0 7
Day 28 0 16
Day 42 18 24
Day 56 29 21
2.Primary Outcome
Title Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE
Hide Description Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Time Frame Day 0 up to Day 56 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per Protocol Population).
Arm/Group Title ChimeriVax™-JE After Placebo JE-VAX®
Hide Arm/Group Description:
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
Overall Number of Participants Analyzed 29 26
Mean (Standard Deviation)
Unit of Measure: 1/dilutions
Day 0 5.0  (0.0) 5.0  (0.0)
Day 14 5.0  (0.0) 15.2  (31.16)
Day 28 5.0  (0.0) 36.5  (55.91)
Day 42 599.8  (1915.35) 184.6  (284.42)
Day 56 3115.9  (4147.71) 66.0  (133.28)
3.Primary Outcome
Title Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.
Hide Description Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']
Time Frame Day 0 (Pre-vaccination) and up to Month 12 After First Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositive status was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).
Arm/Group Title ChimeriVax™-JE After Placebo JE-VAX®
Hide Arm/Group Description:
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
Overall Number of Participants Analyzed 29 26
Measure Type: Number
Unit of Measure: Participants
Day 0 (N = 29, 26) 0 0
Day 56 (N = 29, 26) 29 23
Month 6 (N = 26, 24) 24 7
Month 12 (N = 26, 22) 24 4
4.Primary Outcome
Title Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®
Hide Description Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).
Time Frame Day 0 (pre-vaccination) up to month 12 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).
Arm/Group Title ChimeriVax™-JE After Placebo JE-VAX®
Hide Arm/Group Description:
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
Overall Number of Participants Analyzed 29 26
Mean (Standard Deviation)
Unit of Measure: 1/dilutions
Day 0 (N = 29, 26) 5.0  (0.0) 5.0  (0.0)
Day 56 (N = 29, 26) 3115.9  (4147.71) 485.6  (994.74)
Month 6 (N = 26, 24) 1727.3  (3308.16) 44.4  (131.47)
Month 12 (N = 26, 22) 228.1  (342.01) 17.3  (36.24)
5.Primary Outcome
Title Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®
Hide Description Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.
Time Frame Day 0 up to Day 6 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events were assessed in all participants who received at least one dose of study vaccine pr saline (Intent to Treat Population).
Arm/Group Title ChimeriVax™-JE After Placebo JE-VAX®
Hide Arm/Group Description:
Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Participants
Eye pain 2 1
Grade 3 Eye Pain 0 0
Photophobia 3 1
Grade 3 Photophobia 0 0
Abdominal Pain 4 0
Grade 3 Abdominal Pain 0 0
Diarrhoea 2 4
Grade 3 Diarrhoea 0 0
Nausea 1 4
Grade 3 Nausea 0 0
Vomiting 0 1
Grade 3 Vomiting 0 0
Chills 2 1
Grade 3 Chills 0 0
Fatigue 5 4
Grade 3 Fatigue 0 0
Feeling Hot 6 0
Grade 3 Feeling Hot 0 0
Injection Site Erythema 0 2
Grade 3 Injection Site Erythema 0 0
Injection Site Haemorrhage 1 0
Grade 3 Injection Site Haemorrhage 0 0
Injection Site Pain 3 19
Grade 3 Injection Site Pain 0 0
Malaise 6 9
Grade 3 Malaise 0 1
Contusion 0 1
Grade 3 Contusion 0 0
Excoriation 1 0
Grade 3 Excoriation 0 0
Limb Injury 0 1
Grade 3 Limb Injury 0 0
Body Temperature Increased 1 0
Grade 3 Body Temperature Increased 0 0
Arthralgia 2 3
Grade 3 Arthralgia 0 0
Myalgia 4 6
Grade 3 Myalgia 0 0
Disturbance in Attention 1 0
Grade 3 Disturbance in Attention 0 0
Dizziness 0 1
Grade 3 Dizziness 0 1
Headache 13 9
Grade 3 Headache 0 0
Lethargy 4 7
Grade 3 Lethargy 0 1
Somnolence 8 6
Grade 3 Somnolence 0 0
Pollakiuria 1 0
Grade 3 Pollakiuria 0 0
Dyspnoea 1 3
Grade 3 Dyspnoea 0 0
Pharyngolaryngeal Pain 1 0
Grade 3 Pharyngolaryngeal Pain 0 0
Sinus Congestion 0 1
Grade 3 Sinus Congestion 0 0
Erythema 0 1
Grade 3 Erythema 0 0
Pruritus 1 0
Grade 3 Pruritus 0 0
Rash 1 0
Grade 3 Rash 0 0
Time Frame Adverse events data were collected from Day 0 after vaccination up to Month 12.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ChimeriVax™-JE After Placebo JE-VAX®
Hide Arm/Group Description Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28. Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
All-Cause Mortality
ChimeriVax™-JE After Placebo JE-VAX®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ChimeriVax™-JE After Placebo JE-VAX®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
ChimeriVax™-JE After Placebo JE-VAX®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/30 (83.33%)      29/30 (96.67%)    
Eye disorders     
Eye pain * 1  2/30 (6.67%)  2 1/30 (3.33%)  1
Photophobia * 1  3/30 (10.00%)  3 1/30 (3.33%)  1
Gastrointestinal disorders     
Abdominal pain * 1  5/30 (16.67%)  6 0/30 (0.00%)  0
Diarrhoea * 1  6/30 (20.00%)  6 5/30 (16.67%)  8
Nausea * 1  3/30 (10.00%)  3 5/30 (16.67%)  5
Vomiting * 1  1/30 (3.33%)  1 2/30 (6.67%)  2
General disorders     
Chills * 1  6/30 (20.00%)  6 1/30 (3.33%)  1
Fatigue * 1  7/30 (23.33%)  8 5/30 (16.67%)  5
Feeling Hot * 1  10/30 (33.33%)  11 0/30 (0.00%)  0
Injection Site Erythema * 1  2/30 (6.67%)  2 9/30 (30.00%)  19
Injection Site Haemorrhage * 1  2/30 (6.67%)  2 1/30 (3.33%)  1
Injection Site Induration * 1  1/30 (3.33%)  1 2/30 (6.67%)  2
Injection Site Pain * 1  4/30 (13.33%)  9 24/30 (80.00%)  70
Injection Site Pruritus * 1  0/30 (0.00%)  0 2/30 (6.67%)  3
Injection Site Swelling * 1  0/30 (0.00%)  0 6/30 (20.00%)  8
Malaise * 1  9/30 (30.00%)  10 11/30 (36.67%)  11
Infections and infestations     
Upper Respiratory Tract Infection * 1  3/30 (10.00%)  3 1/30 (3.33%)  1
Injury, poisoning and procedural complications     
Contusion * 1  2/30 (6.67%)  3 3/30 (10.00%)  4
Sunburn * 1  2/30 (6.67%)  2 0/30 (0.00%)  0
Investigations     
White Blood Cell Count Increased * 1  2/30 (6.67%)  2 2/30 (6.67%)  3
White Blood Cells Urine Positive * 1  4/30 (13.33%)  4 3/30 (10.00%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/30 (6.67%)  3 3/30 (10.00%)  3
Myalgia * 1  6/30 (20.00%)  7 7/30 (23.33%)  8
Nervous system disorders     
Dizziness * 1  0/30 (0.00%)  0 2/30 (6.67%)  2
Headache * 1  17/30 (56.67%)  28 12/30 (40.00%)  25
Lethargy * 1  5/30 (16.67%)  8 8/30 (26.67%)  10
Somnolence * 1  9/30 (30.00%)  11 7/30 (23.33%)  7
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  2/30 (6.67%)  2 3/30 (10.00%)  3
Pharyngolaryngeal Pain * 1  4/30 (13.33%)  4 0/30 (0.00%)  0
Sinus Congestion * 1  0/30 (0.00%)  0 2/30 (6.67%)  2
Skin and subcutaneous tissue disorders     
Erythema * 1  0/30 (0.00%)  0 2/30 (6.67%)  2
Rash * 1  2/30 (6.67%)  2 2/30 (6.67%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00319592     History of Changes
Other Study ID Numbers: H-040-008
First Submitted: April 28, 2006
First Posted: April 27, 2006
Results First Submitted: July 11, 2012
Results First Posted: August 16, 2012
Last Update Posted: August 20, 2012