Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    human botulinum neurotoxin a/b immune globulin

Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid

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: NCT01701999
Recruitment Status : Completed
First Posted : October 5, 2012
Results First Posted : February 9, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
California Department of Public Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Botulism
Intervention Biological: rBV A/B
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Hide Arm/Group Description Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months. Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
Period Title: Overall Study
Started 8 37
Completed 8 37
Not Completed 0 0
Arm/Group Title Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2) Total
Hide Arm/Group Description Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months. Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1. Total of all reporting groups
Overall Number of Baseline Participants 8 37 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 37 participants 45 participants
50.3  (13.5) 44.0  (10.7) 45.1  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 37 participants 45 participants
Female
3
  37.5%
20
  54.1%
23
  51.1%
Male
5
  62.5%
17
  45.9%
22
  48.9%
1.Primary Outcome
Title Four-Fold Increase in Neutralizing Antibody Concentration (NAC)
Hide Description Proportion of participants achieving a four-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success).
Time Frame Week 0 to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Hide Arm/Group Description:
Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
Overall Number of Participants Analyzed 8 37
Measure Type: Number
Unit of Measure: proportion of participants
Type A 0.75 0.84
Type B 0.75 0.89
2.Secondary Outcome
Title Three-Fold Increase in Neutralizing Antibody Concentration (NAC)
Hide Description Proportion of participants achieving a three-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success)
Time Frame Week 0 to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Hide Arm/Group Description:
Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
Overall Number of Participants Analyzed 8 37
Measure Type: Number
Unit of Measure: proportion of participants
Type A 0.75 0.95
Type B 0.75 0.89
3.Secondary Outcome
Title Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve
Hide Description Proportion of participants achieving a two-fold increase in the area under the plasma NAC-time curve between Week 0 and Week 12 in comparison with a straight-line extension of the Week 0 NAC to Week 12 for both botulinum toxin A and toxin B. A proportion ≥ 0.50 was considered a success.
Time Frame Week 0 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Hide Arm/Group Description:
Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
Overall Number of Participants Analyzed 8 37
Measure Type: Number
Unit of Measure: proportion of participants
Type A 0.75 0.95
Type B 0.88 0.89
4.Other Pre-specified Outcome
Title Collected Plasma Volume
Hide Description Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis in Part 2.
Time Frame Week 1 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Part 1 were only analyzed for safety data, and one participant in Part 2 was excluded from plasma collection due to not meeting the plasma donor minimum weight requirement.
Arm/Group Title Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Hide Arm/Group Description:
Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
Overall Number of Participants Analyzed 0 36
Mean (Standard Deviation)
Unit of Measure: mL
13463.3  (4440.5)
Time Frame Six months following rBV A/B administration
Adverse Event Reporting Description Adverse events (AEs) indicated with * were largely classified as treatment-related reactions (TRRs). Of the 32 and 186 total AEs in Parts 1 and 2, respectively, 21 (65.6%) and 117 (62.9%) were TRRs within the indicated categories. Also, of the 21 and 117 TRRs in Parts 1 and 2, respectively, 19 (90.5%) and 97 (82.9%) occurred within 7 days of the rBV A/B injection, and 8 of 8 participants in Part 1 (100%) and 30 of 37 in Part 2 (81.1%) had at least one TRR within 7 days of the rBV A/B injection.
 
Arm/Group Title Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Hide Arm/Group Description Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months. Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
All-Cause Mortality
Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Initial Safety and Immunogenicity (Part 1) Safety, Immunogenicity, and Plasma Collection (Part 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   34/37 (91.89%) 
Blood and lymphatic system disorders     
Lymphopenia  1/8 (12.50%)  0/37 (0.00%) 
Neutropenia  1/8 (12.50%)  0/37 (0.00%) 
Gastrointestinal disorders     
Constipation  0/8 (0.00%)  2/37 (5.41%) 
Diarrhoea  1/8 (12.50%)  2/37 (5.41%) 
Nausea*  0/8 (0.00%)  3/37 (8.11%) 
General disorders     
Chills*  0/8 (0.00%)  2/37 (5.41%) 
Injection site anaesthesia*  1/8 (12.50%)  0/37 (0.00%) 
Injection site erythema*  5/8 (62.50%)  19/37 (51.35%) 
Injection site induration*  0/8 (0.00%)  3/37 (8.11%) 
Injection site nodule*  0/8 (0.00%)  2/37 (5.41%) 
Injection site pain*  6/8 (75.00%)  15/37 (40.54%) 
Injection site papule  1/8 (12.50%)  0/37 (0.00%) 
Injection site pruritus*  3/8 (37.50%)  9/37 (24.32%) 
Injection site reaction*  1/8 (12.50%)  0/37 (0.00%) 
Injection site swelling*  3/8 (37.50%)  18/37 (48.65%) 
Injection site urticaria*  0/8 (0.00%)  1/37 (2.70%) 
Malaise*  0/8 (0.00%)  5/37 (13.51%) 
Pain*  0/8 (0.00%)  1/37 (2.70%) 
Pyrexia*  0/8 (0.00%)  2/37 (5.41%) 
Swelling*  0/8 (0.00%)  3/37 (8.11%) 
Infections and infestations     
Nasopharyngitis  0/8 (0.00%)  1/37 (2.70%) 
Staphylococcal infection  0/8 (0.00%)  1/37 (2.70%) 
Tonsillitis  0/8 (0.00%)  1/37 (2.70%) 
Tooth infection  0/8 (0.00%)  1/37 (2.70%) 
Upper respiratory tract infection  1/8 (12.50%)  1/37 (2.70%) 
Injury, poisoning and procedural complications     
Infusion site hematoma  0/8 (0.00%)  1/37 (2.70%) 
Injection site swelling*  0/8 (0.00%)  1/37 (2.70%) 
Procedural complication*  0/8 (0.00%)  14/37 (37.84%) 
Procedural pain  0/8 (0.00%)  3/37 (8.11%) 
Investigations     
Aspartate aminotransferase increased*  0/8 (0.00%)  1/37 (2.70%) 
Blood potassium increased  0/8 (0.00%)  1/37 (2.70%) 
Blood urea increased  0/8 (0.00%)  1/37 (2.70%) 
Blood urine present  1/8 (12.50%)  0/37 (0.00%) 
Body temperature increased*  0/8 (0.00%)  1/37 (2.70%) 
Haematocrit decreased  0/8 (0.00%)  5/37 (13.51%) 
Haemaglobin decreased  1/8 (12.50%)  1/37 (2.70%) 
Haemaglobin increased  0/8 (0.00%)  1/37 (2.70%) 
Platelet count decreased  1/8 (12.50%)  0/37 (0.00%) 
Protein total decreased  0/8 (0.00%)  2/37 (5.41%) 
Urine ketone body present  0/8 (0.00%)  1/37 (2.70%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms*  0/8 (0.00%)  1/37 (2.70%) 
Muscular weakness*  0/8 (0.00%)  1/37 (2.70%) 
Musculoskeletal pain*  1/8 (12.50%)  1/37 (2.70%) 
Myalgia*  0/8 (0.00%)  1/37 (2.70%) 
Pain in extremity  0/8 (0.00%)  1/37 (2.70%) 
Sensation of heaviness*  0/8 (0.00%)  1/37 (2.70%) 
Nervous system disorders     
Dizziness  0/8 (0.00%)  1/37 (2.70%) 
Headache*  0/8 (0.00%)  5/37 (13.51%) 
Paraesthesia*  0/8 (0.00%)  2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  0/8 (0.00%)  2/37 (5.41%) 
Oropharyngeal pain  0/8 (0.00%)  1/37 (2.70%) 
Pulmonary congestion  0/8 (0.00%)  1/37 (2.70%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact  0/8 (0.00%)  1/37 (2.70%) 
Erythema*  0/8 (0.00%)  4/37 (10.81%) 
Petechiae  0/8 (0.00%)  1/37 (2.70%) 
Rash erythematous*  0/8 (0.00%)  1/37 (2.70%) 
Rash maculo-papular  0/8 (0.00%)  1/37 (2.70%) 
Rash papular  1/8 (12.50%)  0/37 (0.00%) 
Skin lesion  0/8 (0.00%)  1/37 (2.70%) 
Sunburn  0/8 (0.00%)  1/37 (2.70%) 
Urticaria*  0/8 (0.00%)  1/37 (2.70%) 
Vascular disorders     
Hypertension  0/8 (0.00%)  1/37 (2.70%) 
1
Term from vocabulary, MedDRA, Version 16.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jessica Khouri
Organization: California Department of Public Health
Phone: 510-231-7600
EMail: Jessica.Khouri@cdph.ca.gov
Layout table for additonal information
Responsible Party: California Department of Public Health
ClinicalTrials.gov Identifier: NCT01701999     History of Changes
Other Study ID Numbers: rBV A/B-CL-001
First Submitted: October 3, 2012
First Posted: October 5, 2012
Results First Submitted: December 15, 2016
Results First Posted: February 9, 2017
Last Update Posted: May 16, 2017