Trial Outcomes & Findings for Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG® (NCT NCT03676634)
NCT ID: NCT03676634
Last Updated: 2021-10-19
Results Overview
Neutralizing Antibody Concentration in Plasma
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Week 0 to Week 4
Results posted on
2021-10-19
Participant Flow
A total of 32 participants were enrolled during the recruiting period from 07 March 2019 to 29 August 2019.
All enrolled participants participated in the study.
Participant milestones
| Measure |
0.5 mL rBV A/B
A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
Screening
|
32
|
|
Overall Study
Participants Received rBV A/B Injection
|
32
|
|
Overall Study
Participants Included in the Plasma-donating Population
|
32
|
|
Overall Study
Participants Completed Follow up
|
32
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
0.5 mL rBV A/B
A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
|
|---|---|
|
Overall Study
Red blood cell loss
|
1
|
|
Overall Study
Out-of-limit pulse
|
2
|
Baseline Characteristics
Tolerability and Immunogenicity of rBV A/B for the Production of BabyBIG®
Baseline characteristics by cohort
| Measure |
0.5 mL rBV A/B
n=32 Participants
A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
|
|---|---|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
|
Previous BabyBIG Plasma Donor
|
24 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
44.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 4Population: Immunogenicity Population: All participants who received rBV A/B, had a baseline NAC, and had at least one post-vaccination immunogenicity assessment up to and including four weeks after administration of rBV A/B
Neutralizing Antibody Concentration in Plasma
Outcome measures
| Measure |
0.5 mL rBV A/B
n=32 Participants
A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
|
|---|---|
|
Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)
Proportion of participants with a ≥4x increase in type A NAC
|
.844 proportion of participants
Interval 0.672 to 0.947
|
|
Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)
Proportion of participants with a ≥3x increase in type A NAC
|
.938 proportion of participants
Interval 0.792 to 0.992
|
|
Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)
Proportion of participants with a ≥4x increase in type B NAC
|
.875 proportion of participants
Interval 0.71 to 0.965
|
|
Proportion of Subjects Achieving Greater Than 3- or 4-Fold Increases in Neutralizing Antibody Concentration (NAC)
Proportion of participants with a ≥3x increase in type B NAC
|
.906 proportion of participants
Interval 0.75 to 0.98
|
SECONDARY outcome
Timeframe: Week 0 to 12Population: Immunogenicity Population: All participants who received rBV A/B, had a baseline NAC, and had at least one post-vaccination immunogenicity assessment up to and including four weeks after administration of rBV A/B
Neutralizing Antibody Concentration in Plasma
Outcome measures
| Measure |
0.5 mL rBV A/B
n=32 Participants
A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
|
|---|---|
|
Proportion of Subjects Achieving Greater Than 2-Fold Increase in Neutralizing Antibody Concentration (NAC)
two times or greater increase in type A NAC compared with Week 0
|
.906 proportion of participants
Interval 0.75 to 0.98
|
|
Proportion of Subjects Achieving Greater Than 2-Fold Increase in Neutralizing Antibody Concentration (NAC)
two times or greater increase in type B NAC compared with Week 0
|
.844 proportion of participants
Interval 0.672 to 0.947
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 to 4Population: Plasma-Donating Population: all participants who received rBV A/B and donated at least one plasma unit.
Neutralizing Antibody Concentration in Plasma
Outcome measures
| Measure |
0.5 mL rBV A/B
n=32 Participants
A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
|
|---|---|
|
Volume of Plasma Collected With an Acceptable Anti-type A or Anti-type B Titer
Total volume of plasma from all donating participants
|
470,102 mL
|
|
Volume of Plasma Collected With an Acceptable Anti-type A or Anti-type B Titer
Total volume of plasma from donating participants with any positive titer
|
470,102 mL
|
|
Volume of Plasma Collected With an Acceptable Anti-type A or Anti-type B Titer
Total volume of plasma from donating participants with positive anti-A titer
|
470,102 mL
|
|
Volume of Plasma Collected With an Acceptable Anti-type A or Anti-type B Titer
Total volume of plasma from donating participants with positive anti-B titer
|
469,411 mL
|
Adverse Events
0.5 mL rBV A/B
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.5 mL rBV A/B
n=32 participants at risk
A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
3.1%
1/32 • Number of events 1 • Non-serious AEs (injection site reactions/systemic reactions) were only collected from day 0 - day 7 during the participant diary collection period. For the rest of the study (from day 7 through 12 weeks of site visits and through the week 26 follow up phone call), AEs were only collected if they were SAEs.
Mortality, Adverse Events, and Serious Adverse Event definitions are as described on clinicaltrials.gov. Any anticipated or unanticipated events (not included in the serious adverse event table) grouped by organ system, with the number and frequency of such events.
|
Other adverse events
| Measure |
0.5 mL rBV A/B
n=32 participants at risk
A single 0.5-mL intramuscular injection of 40 μg of rBV A/B was administered to each participant on Day 0 to stimulate the production of antibodies against botulinum toxin type A and type B.
|
|---|---|
|
General disorders
injection site erythema
|
12.5%
4/32 • Number of events 4 • Non-serious AEs (injection site reactions/systemic reactions) were only collected from day 0 - day 7 during the participant diary collection period. For the rest of the study (from day 7 through 12 weeks of site visits and through the week 26 follow up phone call), AEs were only collected if they were SAEs.
Mortality, Adverse Events, and Serious Adverse Event definitions are as described on clinicaltrials.gov. Any anticipated or unanticipated events (not included in the serious adverse event table) grouped by organ system, with the number and frequency of such events.
|
|
General disorders
injection site induration
|
9.4%
3/32 • Number of events 3 • Non-serious AEs (injection site reactions/systemic reactions) were only collected from day 0 - day 7 during the participant diary collection period. For the rest of the study (from day 7 through 12 weeks of site visits and through the week 26 follow up phone call), AEs were only collected if they were SAEs.
Mortality, Adverse Events, and Serious Adverse Event definitions are as described on clinicaltrials.gov. Any anticipated or unanticipated events (not included in the serious adverse event table) grouped by organ system, with the number and frequency of such events.
|
|
General disorders
injection site pain
|
3.1%
1/32 • Number of events 1 • Non-serious AEs (injection site reactions/systemic reactions) were only collected from day 0 - day 7 during the participant diary collection period. For the rest of the study (from day 7 through 12 weeks of site visits and through the week 26 follow up phone call), AEs were only collected if they were SAEs.
Mortality, Adverse Events, and Serious Adverse Event definitions are as described on clinicaltrials.gov. Any anticipated or unanticipated events (not included in the serious adverse event table) grouped by organ system, with the number and frequency of such events.
|
Additional Information
Stephen S. Arnon, M.D., M.P.H., Chief, Infant Botulism Treatment and Prevention Program
California Department of Public Health
Phone: 510-231-7600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place