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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

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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
Name/Title: Dr. Jessica Khouri
Organization: California Department of Public Health
Phone: 510-231-7600
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