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Trial record 1 of 1 for:    H-030-008
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Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00127803
Recruitment Status : Completed
First Posted : August 9, 2005
Results First Posted : May 21, 2012
Last Update Posted : September 14, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Clostridium Infections
Interventions Biological: Placebo (vaccine diluent)
Biological: Clostridium difficile vaccine
Enrollment 50
Recruitment Details Participants were enrolled from 13 July 2005 to 27 July 2005 in 2 medical centers in the US.
Pre-assignment Details A total of 50 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group
Hide Arm/Group Description Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
Period Title: Overall Study
Started 13 13 12 12
Completed 10 13 12 11
Not Completed 3 0 0 1
Reason Not Completed
Adverse Event             2             0             0             0
Withdrawal by Subject             1             0             0             0
Lost to Follow-up             0             0             0             1
Arm/Group Title Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group Total
Hide Arm/Group Description Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56. Total of all reporting groups
Overall Number of Baseline Participants 13 13 12 12 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 12 participants 12 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
13
 100.0%
12
 100.0%
12
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 12 participants 12 participants 50 participants
33.6  (12.49) 30.8  (10.26) 30.4  (9.78) 32.6  (9.07) 31.9  (10.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 12 participants 12 participants 50 participants
Female
10
  76.9%
6
  46.2%
8
  66.7%
9
  75.0%
33
  66.0%
Male
3
  23.1%
7
  53.8%
4
  33.3%
3
  25.0%
17
  34.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 12 participants 12 participants 50 participants
13 13 12 12 50
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Hide Description [Not Specified]
Time Frame Day 0 and up to 7 days post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety assessments were on the safety population.
Arm/Group Title Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group
Hide Arm/Group Description:
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
Overall Number of Participants Analyzed 13 13 12 12
Measure Type: Number
Unit of Measure: Participants
Erythema Day 0 2 0 1 2
Erythema Day 28 0 3 3 2
Erythema Day 56 2 2 3 3
Tenderness Day 0 0 0 3 1
Tenderness Day 28 0 1 0 2
Tenderness Day 56 0 2 1 1
2.Primary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Hide Description [Not Specified]
Time Frame Day 0 to up to 70 days post-first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety assessments were on the safety population.
Arm/Group Title Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group
Hide Arm/Group Description:
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
Overall Number of Participants Analyzed 13 13 12 12
Measure Type: Number
Unit of Measure: Participants
Injection site pain 8 11 11 12
Injection site erythema 2 6 5 6
Red blood cells urine positive 2 5 6 5
Protein urine present 2 6 4 5
Eosinophil count increased 1 2 5 3
Headache 4 4 3 0
Upper respiratory tract infection 2 3 2 3
White blood cells urine positive 3 1 3 3
Pain in extremity 5 0 1 3
Injection site swelling 1 2 3 3
Diarrhoea 3 2 0 3
Blood urea increased 0 1 4 2
Injection site induration 0 1 4 2
Abdominal pain 1 0 1 4
Injection site warmth 1 1 1 3
Fatigue 2 1 1 2
Myalgia 2 1 1 1
Injection site pruritus 0 0 1 3
White blood cell count decreased 0 0 2 2
Blood potassium increased 3 1 0 0
Sensation of heaviness 0 0 1 2
Injection site irritation 2 0 1 0
Sinus headache 0 2 0 0
White blood cell count increased 0 2 0 0
Blood potassium increased 3 1 0 0
Injection site paraesthesia 2 0 0 0
3.Secondary Outcome
Title Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Hide Description

Seroconversion was defined as a ≥4-fold increase in antibody levels from Baseline. For values below the limit of quantification (LLQ) for the assay, the LLQ was used.

Serum anti-toxin IgG levels were determined by enzyme linked immunosorbent assay (ELISA).
Time Frame Days 28, 56, 70, and 236 Post First Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum anti-toxin levels were assessed in the Fully Evaluable (Per-Protocol) Population.
Arm/Group Title Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group
Hide Arm/Group Description:
Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
Overall Number of Participants Analyzed 10 13 12 11
Measure Type: Number
Unit of Measure: Participants
Toxin A Day 28 0 6 5 10
Toxin A Day 56 0 13 12 11
Toxin A Day 70 0 13 12 11
Toxin A Day 236 0 12 12 10
Toxin B Day 28 0 2 5 7
Toxin B Day 56 0 3 6 7
Toxin B Day 70 0 6 7 8
Toxin B Day 236 0 2 4 6
Time Frame Adverse events data were collected from the day of vaccination for up to 1 year post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group
Hide Arm/Group Description Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56. Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
All-Cause Mortality
Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Group Low Dose Vaccine Group Medium Dose Vaccine Group High Dose Vaccine Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   13/13 (100.00%)   12/12 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders         
Blood bilirubin increased * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Blood calcium increased * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Blood creatinine increased * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Blood potassium decreased * 1  1/13 (7.69%)  1/13 (7.69%)  1/12 (8.33%)  1/12 (8.33%) 
Blood potassium increased * 1  3/13 (23.08%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Blood urea increased * 1  0/13 (0.00%)  1/13 (7.69%)  4/12 (33.33%)  2/12 (16.67%) 
Eosinophil count increased * 1  1/13 (7.69%)  2/13 (15.38%)  5/12 (41.67%)  3/12 (25.00%) 
Lymphocyte count decreased * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  1/12 (8.33%) 
Neutrophil count decreased * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Protein urine present * 1  2/13 (15.38%)  6/13 (46.15%)  4/12 (33.33%)  5/12 (41.67%) 
Red blood cell count increased * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Red blood cells urine positive * 1  2/13 (15.38%)  5/13 (38.46%)  6/12 (50.00%)  5/12 (41.67%) 
Transaminase increased * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
White blood cell count decreased * 1  0/13 (0.00%)  0/13 (0.00%)  2/12 (16.67%)  2/12 (16.67%) 
White blood cell count increased * 1  0/13 (0.00%)  2/13 (15.38%)  0/12 (0.00%)  0/12 (0.00%) 
White blood cells urine positive * 1  3/13 (23.08%)  1/13 (7.69%)  3/12 (25.00%)  3/12 (25.00%) 
Eye disorders         
Eyelid cyst * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%)  4/12 (33.33%) 
Diarrhoea * 1  3/13 (23.08%)  2/13 (15.38%)  0/12 (0.00%)  3/12 (25.00%) 
Dry mouth * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Lip pain * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Vomiting * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  1/12 (8.33%) 
General disorders         
Asthenia * 1  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Fatigue * 1  2/13 (15.38%)  1/13 (7.69%)  1/12 (8.33%)  2/12 (16.67%) 
Induration * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site anaesthesia * 1  1/13 (7.69%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site discomfort * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site erythema * 1  2/13 (15.38%)  6/13 (46.15%)  5/12 (41.67%)  6/12 (50.00%) 
Injection site haemorrhage * 1  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Injection site induration * 1  0/13 (0.00%)  1/13 (7.69%)  4/12 (33.33%)  2/12 (16.67%) 
Injection site irritation * 1  2/13 (15.38%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Injection site oedema * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Injection site pain * 1  8/13 (61.54%)  11/13 (84.62%)  11/12 (91.67%)  12/12 (100.00%) 
Injection site paraesthesia * 1  2/13 (15.38%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site pruritus * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  3/12 (25.00%) 
Injection site swelling * 1  1/13 (7.69%)  2/13 (15.38%)  3/12 (25.00%)  3/12 (25.00%) 
Injection site warmth * 1  1/13 (7.69%)  1/13 (7.69%)  1/12 (8.33%)  3/12 (25.00%) 
Malaise * 1  1/13 (7.69%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Oedema peripheral * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Pyrexia * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Infections and infestations         
Bronchitis * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Herpes simplex * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Upper respiratory tract infection * 1  2/13 (15.38%)  3/13 (23.08%)  2/12 (16.67%)  3/12 (25.00%) 
Urinary tract infection * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Viral infection * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders         
Anorexia * 1  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/13 (7.69%)  1/13 (7.69%)  0/12 (0.00%)  1/12 (8.33%) 
Back pain * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Joint swelling * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Limb discomfort * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Musculoskeletal stiffness * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Myalgia * 1  2/13 (15.38%)  1/13 (7.69%)  1/12 (8.33%)  1/12 (8.33%) 
Pain in extremity * 1  5/13 (38.46%)  0/13 (0.00%)  1/12 (8.33%)  3/12 (25.00%) 
Sensation of heaviness * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  2/12 (16.67%) 
Temporomandibular joint syndrome * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Nervous system disorders         
Dizziness * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Headache * 1  4/13 (30.77%)  4/13 (30.77%)  3/12 (25.00%)  0/12 (0.00%) 
Sinus headache * 1  0/13 (0.00%)  2/13 (15.38%)  0/0  0/12 (0.00%) 
Psychiatric disorders         
Anxiety * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Nervousness * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Reproductive system and breast disorders         
Metorrhagia * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Pelvic pain * 1  0/13 (0.00%)  0/13 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Nasal congestion * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Pharyngeal erythema * 1  0/13 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/12 (0.00%) 
Pharyngolaryngeal pain * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Sinus congestion * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Throat irritation * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders         
Eczema * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/2 (50.00%) 
Erythema * 1  1/13 (7.69%)  0/13 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Rash * 1  0/13 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Skin irritation * 1  1/13 (7.69%)  0/13 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.0
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00127803    
Other Study ID Numbers: H-030-008
First Submitted: August 5, 2005
First Posted: August 9, 2005
Results First Submitted: March 13, 2012
Results First Posted: May 21, 2012
Last Update Posted: September 14, 2012