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Trial record 1 of 1 for:    H-040-009
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A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX

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ClinicalTrials.gov Identifier: NCT00314145
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : December 5, 2012
Last Update Posted : December 6, 2012
Sponsor:
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
Biological: JE-VAX®
Enrollment 820
Recruitment Details Participants were enrolled and treated from 07 November 2005 to 15 November 2006 at 5 clinical centers in Australia and 5 clinical centers in the US.
Pre-assignment Details A total of 820 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title JE-VAX® ChimeriVax™-JE
Hide Arm/Group Description All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
Period Title: Overall Study
Started 410 410
Completed 389 381
Not Completed 21 29
Reason Not Completed
Withdrawal by Subject             8             10
Lost to Follow-up             5             12
Physician Decision             3             4
Adverse Event             0             3
Protocol Violation             3             0
Sponsor Decision             2             0
Arm/Group Title JE-VAX® ChimeriVax™-JE Total
Hide Arm/Group Description All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms. Total of all reporting groups
Overall Number of Baseline Participants 410 410 820
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 410 participants 410 participants 820 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
410
 100.0%
410
 100.0%
820
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 410 participants 410 participants 820 participants
37.0  (14.81) 37.7  (15.11) 37.4  (14.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 410 participants 410 participants 820 participants
Female
205
  50.0%
217
  52.9%
422
  51.5%
Male
205
  50.0%
193
  47.1%
398
  48.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 410 participants 410 participants 820 participants
Australia 203 120 323
United States 207 290 497
1.Primary Outcome
Title Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Hide Description Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.
Time Frame Up to Day 60 post-first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
Arm/Group Title JE-VAX® ChimeriVax™-JE
Hide Arm/Group Description:
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
Overall Number of Participants Analyzed 365 346
Measure Type: Number
Unit of Measure: Participants
Day 44 (N = 0, 346) NA [1]  324
Day 60 (N = 365, 346) 273 343
[1]
Seroconversion was not assessed at this time point for this group.
2.Primary Outcome
Title Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®
Hide Description

Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.

Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash.

Time Frame Day 0 (Pre-vaccination) up to 60 days post-first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment emergent local adverse events and systemic reactions were assessed in all subjects who had at least one injection (ChimeriVax™-JE, JE-Vax®, or placebo), according to the treatment actually received (Safety Population).
Arm/Group Title JE-VAX® ChimeriVax™-JE
Hide Arm/Group Description:
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
Overall Number of Participants Analyzed 410 410
Measure Type: Number
Unit of Measure: Participants
Injection Site Pain 262 105
Injection Site Erythema 123 27
Injection Site Pruritus 107 29
Injection Site Swelling 85 15
Injection Site Hemorrhage 20 14
Injection Site Rash 6 2
Injection Site Edema 2 0
Injection Site Joint Pain 1 1
Injection Site Reaction 1 1
Injection Site Discomfort 1 0
Injection Site Joint Movement Impairment 0 1
Injection Site Warmth 0 1
Venipuncture Site Bruise 1 0
Fatigue 131 152
Malaise 113 113
Chills 32 43
Pyrexia 18 14
Headache 190 193
Myalgia 107 105
Arthralgia 58 58
Diarrhea 56 57
Nausea 53 56
Vomiting 15 13
Rash 26 23
3.Secondary Outcome
Title Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Hide Description Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Time Frame Up to Day 60 post-first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
Arm/Group Title JE-VAX® ChimeriVax™-JE
Hide Arm/Group Description:
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
Overall Number of Participants Analyzed 365 346
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 44 (N = 0, 346)
NA [1] 
(NA to NA)
312.3
(255.1 to 382.3)
Day 60 (N = 365, 346)
37.4
(32.5 to 42.9)
1391.7
(1156.6 to 1674.5)
[1]
Geometric mean titers were not assessed at this time point for this group.
4.Secondary Outcome
Title Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination
Hide Description Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).
Time Frame Day 60 post-first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).
Arm/Group Title JE-VAX® ChimeriVax™-JE
Hide Arm/Group Description:
All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
Overall Number of Participants Analyzed 365 346
Measure Type: Number
Unit of Measure: Participants
Titer < 10 63 3
Titer 10 to < 20 29 0
Titer 20 to < 40 51 4
Titer 40 to < 160 151 18
Titer 160 to < 640 63 76
Titer 640 to < 2560 6 75
Titer ≥ 2560 2 170
Time Frame Adverse events data were collected from Day 0 (post-vaccination) through Day 60 post first vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title JE-VAX® ChimeriVax™-JE
Hide Arm/Group Description All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30. All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
All-Cause Mortality
JE-VAX® ChimeriVax™-JE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
JE-VAX® ChimeriVax™-JE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/410 (0.73%)      2/410 (0.49%)    
General disorders     
Non Cardiac Chest Pain  1  0/410 (0.00%)  0 1/410 (0.24%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/410 (0.24%)  1 0/410 (0.00%)  0
Immune system disorders     
Drug Hypersensitivity  1  1/410 (0.24%)  1 0/410 (0.00%)  0
Injury, poisoning and procedural complications     
Head Injury  1  0/410 (0.00%)  0 1/410 (0.24%)  1
Nervous system disorders     
Multiple Sclerosis  1  0/410 (0.00%)  0 1/410 (0.24%)  1
Parkinson's Disease  1  0/410 (0.00%)  0 1/410 (0.24%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Airways Disease Exacerbated  1  1/410 (0.24%)  1 0/410 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
JE-VAX® ChimeriVax™-JE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   262/410 (63.90%)      193/410 (47.07%)    
Gastrointestinal disorders     
Diarrhea  1  56/410 (13.66%)  80 57/410 (13.90%)  99
Nausea  1  53/410 (12.93%)  96 56/410 (13.66%)  75
General disorders     
Chills  1  32/410 (7.80%)  48 43/410 (10.49%)  68
Fatigue  1  131/410 (31.95%)  399 152/410 (37.07%)  366
Injection Site Pain  1  262/410 (63.90%)  804 105/410 (25.61%)  207
Injection Site Erythema  1  123/410 (30.00%)  256 27/410 (6.59%)  35
Injection Site Pruritus  1  107/410 (26.10%)  187 29/410 (7.07%)  46
Injection Site Swelling  1  85/410 (20.73%)  149 15/410 (3.66%)  16
Malaise  1  113/410 (27.56%)  248 113/410 (27.56%)  224
Musculoskeletal and connective tissue disorders     
Myalgia  1  107/410 (26.10%)  228 105/410 (25.61%)  192
Arthralgia  1  58/410 (14.15%)  99 58/410 (14.15%)  122
Nervous system disorders     
Headache  1  190/410 (46.34%)  546 193/410 (47.07%)  465
Skin and subcutaneous tissue disorders     
Rash  1  26/410 (6.34%)  36 23/410 (5.61%)  33
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7.1
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: NCT00314145     History of Changes
Other Study ID Numbers: H-040-009
First Submitted: April 11, 2006
First Posted: April 13, 2006
Results First Submitted: November 6, 2012
Results First Posted: December 5, 2012
Last Update Posted: December 6, 2012