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Trial record 1 of 1 for:    H-040-005
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A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults

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ClinicalTrials.gov Identifier: NCT00981175
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : April 29, 2011
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Encephalitis
Japanese Encephalitis
Interventions Biological: Live attenuated Japanese encephalitis virus, then ChimeriVax diluent
Biological: ChimeriVax diluent, then Live attenuated Japanese encephalitis virus
Enrollment 202
Recruitment Details Participants were enrolled and vaccinated from 14 April 2003 to 05 January 2004 at 1 clinical center in Australia.
Pre-assignment Details A total of 202 participants who met the inclusion/exclusion criteria were enrolled and vaccinated. A subset of the participants also received a booster vaccine at month 6. A report on all participants who received the primary and booster vaccination and the primary vaccination only are presented.
Arm/Group Title ChimeriVax™-JE Vaccine First, Then Placebo Placebo First, Then ChimeriVax™-JE Vaccine
Hide Arm/Group Description Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28. Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28.
Period Title: Primary Dose Vaccination
Started 101 101
Completed 98 99
Not Completed 3 2
Reason Not Completed
Adverse Event             1             0
Protocol Violation             0             1
Lost to Follow-up             2             1
Period Title: Booster Dose Vaccination
Started 55 [1] 43 [1]
Completed 53 40
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             2             3
[1]
A sub-set of participants in the group received the booster ChimeriVax™-JE vaccine.
Arm/Group Title ChimeriVax™-JE Vaccine First , Then Placebo Placebo First, Then ChimeriVax™-JE Vaccine Booster ChimeriVax™-JE Vaccine Total
Hide Arm/Group Description Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28. Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28. Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28 Total of all reporting groups
Overall Number of Baseline Participants 101 101 0 202
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 101 participants 0 participants 202 participants
<=18 years 0 0 0
Between 18 and 65 years 101 101 202
>=65 years 0 0 0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 101 participants 0 participants 202 participants
26.1  (7.36) 27.7  (8.25) 26.9  (7.84)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 101 participants 0 participants 202 participants
Female 13 15 28
Male 88 86 174
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 101 participants 101 participants 0 participants 202 participants
101 101 202
1.Primary Outcome
Title Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose
Hide Description Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity was assessed in the Intent-to-Treat Population.
Arm/Group Title ChimeriVax™-JE Vaccine (Single or Primary) Booster ChimeriVax™-JE Vaccine No Booster Vaccine
Hide Arm/Group Description:
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
Participants received ChimeriVax™-JE vaccine booster at month 6.
Participants did not receive a booster dose Chimerivax™-JE vaccine
Overall Number of Participants Analyzed 201 0 0
Measure Type: Number
Unit of Measure: Participants
PRNT50 ≥ 10 [N = 197] 194
PRNT50 ≥ 20 [N = 197] 191
2.Primary Outcome
Title Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.
Hide Description Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.
Time Frame Days 0 to 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Injection site reactions were assessed in the Safety Population.
Arm/Group Title ChimeriVax™-JE Vaccine Placebo Vaccine Booster ChimeriVax™-JE Vaccine
Hide Arm/Group Description:
Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
Participants received a dose of placebo vaccine (diluent)at either Day 0 or Day 28
Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
Overall Number of Participants Analyzed 201 199 98
Measure Type: Number
Unit of Measure: Participants
Injection site Pain 7 5 0
Injection site Reaction NOS 6 4 0
Injection site Erythema 4 5 0
Injection site Swelling 2 6 1
Injection site Bruising 1 1 0
Injection site Nodule 1 0 0
Injection site Pigmentation Changes 1 1 0
Injection site Pruritus 1 0 0
3.Secondary Outcome
Title Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.
Hide Description Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and pre- and post-Booster vaccination.
Time Frame Month 6 pre- and post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity was assessed in the Intent to Treat Population pre- and post-booster vaccination.
Arm/Group Title ChimeriVax™-JE Vaccine (Single or Primary) Booster ChimeriVax™-JE Vaccine No Booster Vaccine
Hide Arm/Group Description:
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
Participants received ChimeriVax™-JE vaccine booster at month 6.
Participants did not receive a booster dose Chimerivax™-JE vaccine
Overall Number of Participants Analyzed 0 97 103
Measure Type: Number
Unit of Measure: Participants
Pre-booster PRNT50 ≥ 10 [N = 0, 98, 93] 95 90
Post-booster PRNT50 ≥ 10 [N = 0, 97, 0] 97 NA [1] 
Pre-booster PRNT50 ≥ 20 [N = 0, 98, 93] 93 87
Post-booster PRNT50 ≥ 20 [N = 0, 97, 0] 97 NA [1] 
[1]
Participants did not receive treatment
4.Secondary Outcome
Title Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
Hide Description Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at 6 month.
Time Frame Month 12 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity was assessed in the Intent to Treat Population
Arm/Group Title ChimeriVax™-JE Vaccine (Single or Primary) Booster ChimeriVax™-JE Vaccine No Booster Vaccine
Hide Arm/Group Description:
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
Participants received ChimeriVax™-JE vaccine booster at month 6.
Participants did not receive a booster dose Chimerivax™-JE vaccine
Overall Number of Participants Analyzed 0 97 103
Measure Type: Number
Unit of Measure: Participants
PRNT50 ≥ 10 [N = 0, 80, 76] 79 72
PRNT50 ≥ 20 [N = 0, 80, 76] 78 68
5.Secondary Outcome
Title Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.
Hide Description Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at month 24.
Time Frame Month 24 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity was assessed in the Intent to Treat Population
Arm/Group Title ChimeriVax™-JE Vaccine (Single or Primary) Booster ChimeriVax™-JE Vaccine No Booster Vaccine
Hide Arm/Group Description:
Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
Participants received ChimeriVax™-JE vaccine booster at month 6.
Participants did not receive a booster dose Chimerivax™-JE vaccine
Overall Number of Participants Analyzed 0 97 103
Measure Type: Number
Unit of Measure: Participants
PRNT50 ≥ 10 [N = 0, 70, 71] 69 64
PRNT50 ≥ 20 [N = 0, 70, 71] 67 60
6.Secondary Outcome
Title Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.
Hide Description Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.
Time Frame Day 0 up to 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment emergent adverse events were assessed in the Safety Population.
Arm/Group Title ChimeriVax™-JE Vaccine Placebo Vaccine Booster ChimeriVax™-JE Vaccine
Hide Arm/Group Description:
Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
Participants received a dose of placebo vaccine (diluent) at either Day 0 or Day 28
Participants received a booster dose of ChimeriVax™-JE vaccine at month 6 following primary ChimeriVax™-JE and Diluent vaccination at Day 0 and Day 28
Overall Number of Participants Analyzed 201 199 98
Measure Type: Number
Unit of Measure: Participants
Any Adverse Event 47 45 4
Headache 12 10 0
Injection Site Pain 7 5 0
Injection Site Reaction Not Otherwise Specified 6 4 0
Lethargy 5 2 0
Viral Infection Not Otherwise Specified 5 10 0
Injection Site Erythema 4 5 0
Fatigue 3 2 0
Lymphadenopathy 2 0 0
Injection Site Swelling 2 6 1
Diarrhea Not Otherwise Specified 2 1 0
Nausea 2 2 0
Pyrexia 2 2 3
Liver Function Test Abnormal 2 2 0
Myalgia 2 2 0
Upper Respiratory Tract Infection NOS 2 9 0
Vomiting Not Otherwise Specified 1 0 0
Injection Site Bruising 1 1 0
Injection Site Nodule 1 0 0
Injection Site Pigmentation Changes 1 1 0
Injection Site Pruritus 1 0 0
Malaise 1 2 0
Rigors 1 0 0
Gastroenteritis Not Otherwise Specified 1 0 0
Anorexia 1 0 0
Pharygolaryngeal Pain 1 0 0
Insomnia 0 1 0
Dry Eyes Not Otherwise Specified 0 1 0
Disturbance in Attention 0 1 0
Contusion 0 1 0
Flushing 0 1 0
Time Frame Adverse event data were collected from day of vaccination (Day 0) for up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ChimeriVax™-JE Vaccine First , Then Placebo Placebo First, Then ChimeriVax™-JE Vaccine Booster ChimeriVax™-JE Vaccine
Hide Arm/Group Description Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28. Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28. Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
All-Cause Mortality
ChimeriVax™-JE Vaccine First , Then Placebo Placebo First, Then ChimeriVax™-JE Vaccine Booster ChimeriVax™-JE Vaccine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ChimeriVax™-JE Vaccine First , Then Placebo Placebo First, Then ChimeriVax™-JE Vaccine Booster ChimeriVax™-JE Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/201 (1.00%)      1/199 (0.50%)      0/98 (0.00%)    
Gastrointestinal disorders       
Rectal Haemorrhage * 1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/98 (0.00%)  0
Infections and infestations       
Gastroenteritis Not Otherwise Specified * 1  1/201 (0.50%)  1 0/199 (0.00%)  0 0/98 (0.00%)  0
Viral Infection Not Otherwise Specified * 1  0/201 (0.00%)  0 1/199 (0.50%)  1 0/98 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
ChimeriVax™-JE Vaccine First , Then Placebo Placebo First, Then ChimeriVax™-JE Vaccine Booster ChimeriVax™-JE Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/201 (13.43%)      35/199 (17.59%)      3/98 (3.06%)    
Gastrointestinal disorders       
Diarrhea Not Otherwise Specified  1  2/201 (1.00%)  2 6/199 (3.02%)  6 1/98 (1.02%)  1
General disorders       
Injection Site Pain  1  7/201 (3.48%)  7 5/199 (2.51%)  5 0/98 (0.00%)  0
Injection Site Reaction Not Otherwise Specified  1  6/201 (2.99%)  6 4/199 (2.01%)  4 0/98 (0.00%)  0
Injection Site Swelling  1  2/201 (1.00%)  2 6/199 (3.02%)  6 1/98 (1.02%)  1
Lethargy  1  11/201 (5.47%)  11 5/199 (2.51%)  5 1/98 (1.02%)  1
Pyrexia  1  2/201 (1.00%)  2 3/199 (1.51%)  3 3/98 (3.06%)  3
Infections and infestations       
Upper Respiratory Tract Infection NOS  1  24/201 (11.94%)  27 35/199 (17.59%)  38 1/98 (1.02%)  1
Viral Infection Not Otherwise Specified  1  5/201 (2.49%)  5 11/199 (5.53%)  11 0/98 (0.00%)  0
Nervous system disorders       
Headache  1  27/201 (13.43%)  31 20/199 (10.05%)  20 1/98 (1.02%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6.0
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: NCT00981175     History of Changes
Other Study ID Numbers: H-040-005
First Submitted: September 21, 2009
First Posted: September 22, 2009
Results First Submitted: April 5, 2011
Results First Posted: April 29, 2011
Last Update Posted: July 16, 2012