Trial Outcomes & Findings for Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG® (NCT NCT06112834)
NCT ID: NCT06112834
Last Updated: 2026-07-30
Results Overview
The primary immunogenicity endpoint is the proportion of participants achieving a three or four times or greater increase in NAC by Week 4 compared with Week 0. A positive response will be defined as achieving this level of increase in at least 50% of the participants for botulinum toxin type A and type B.
COMPLETED
PHASE2
25 participants
Week 0 to Week 4
2026-07-30
Participant Flow
A total of 25 participants were enrolled during the recruiting period from 09 July 2024 to 17 October 2024.
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
|
25
|
|
Overall Study
Screening
|
25
|
|
Overall Study
Participants received rBV A/B injection
|
25
|
|
Overall Study
Participants included in the plasma-donating population
|
22
|
|
Overall Study
Participants completed follow up
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®
Baseline characteristics by cohort
| Measure |
0.5 mL rBV A/B
n=25 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=20 Participants
|
|
Age, Continuous
|
48.0 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=20 Participants
|
|
Previous BabyBIG Plasma Donor
|
24 Participants
n=20 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
The primary immunogenicity endpoint is the proportion of participants achieving a three or four times or greater increase in NAC by Week 4 compared with Week 0. A positive response will be defined as achieving this level of increase in at least 50% of the participants for botulinum toxin type A and type B.
Outcome measures
| Measure |
0.5 mL rBV A/B
n=25 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 Equal to or Greater Than 4-Fold Increase in Neutralizing Antibody Concentration (NAC)
Proportion of participants with a ≥3 × increase in Type A NAC
|
0.84 proportion of participants
Interval 0.639 to 0.955
|
|
Proportion of Subjects Achieving Equal to or Greater Than 4-Fold Increase in Neutralizing Antibody Concentration (NAC)
Proportion of participants with a ≥4 × increase in type A NAC
|
0.84 proportion of participants
Interval 0.639 to 0.955
|
|
Proportion of Subjects Achieving Equal to or Greater Than 4-Fold Increase in Neutralizing Antibody Concentration (NAC)
Proportion of participants with a ≥4 × increase in Type B NAC
|
0.76 proportion of participants
Interval 0.549 to 0.906
|
|
Proportion of Subjects Achieving Equal to or Greater Than 4-Fold Increase in Neutralizing Antibody Concentration (NAC)
Proportion of participants with a ≥3 × increase in Type B NAC
|
0.84 proportion of participants
Interval 0.639 to 0.955
|
SECONDARY outcome
Timeframe: Week 0 to Week 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
The proportion of participants achieving two times increase in the area under the plasma concentration-time curve between Week 0 and Week 12 in NAC in comparison to a straight-line extension of the Week 0 NAC to Week 12. A positive response will be defined as achieving this level of increase in at least 50% of participants for botulinum toxin type A and type B.
Outcome measures
| Measure |
0.5 mL rBV A/B
n=25 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 2-Fold Increase in Area Under the Plasma Concentration-Time Curve in Neutralizing Antibody Concentration (NAC)
two times or greater increase in type A NAC compared with Week 0
|
0.92 proportion of participants
Interval 0.74 to 0.99
|
|
Proportion of Subjects Achieving 2-Fold Increase in Area Under the Plasma Concentration-Time Curve in Neutralizing Antibody Concentration (NAC)
two times or greater increase in type B NAC compared with Week 0
|
0.92 proportion of participants
Interval 0.74 to 0.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 to Week 12Population: Plasma-Donating Population: all participants who received rBV A/B and donated at least one plasma unit. All participants (n=22) in the plasma-donating population had positive anti-A and anti-B titers.
The volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis for use in BabyBIG manufacture.
Outcome measures
| Measure |
0.5 mL rBV A/B
n=22 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 Anti-Botulinum Toxin Type A and Anti-Botulinum Toxin Type B Antibody Titers
Total volume of plasma from all donating participants
|
356,436 mL
|
|
Volume of Plasma Collected With Anti-Botulinum Toxin Type A and Anti-Botulinum Toxin Type B Antibody Titers
Total volume of plasma from all donating participants with a positive titer (mg[%])
|
356,436 mL
|
|
Volume of Plasma Collected With Anti-Botulinum Toxin Type A and Anti-Botulinum Toxin Type B Antibody Titers
Total volume of plasma from donating participants with positive anti-A titer
|
356,436 mL
|
|
Volume of Plasma Collected With Anti-Botulinum Toxin Type A and Anti-Botulinum Toxin Type B Antibody Titers
Total volume of plasma from donating participants with positive anti-B titer
|
356,436 mL
|
Adverse Events
0.5 mL rBV A/B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jessica M. Khouri, M.D., Senior Medical Officer
California Department of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place