Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG® (NCT06112834) | Clinical Trial Compass
CompletedPhase 2
Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®
United States25 participantsStarted 2024-07-09
Plain-language summary
This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection will be conducted to collect source plasma for potential use in the production of BabyBIG and to evaluate safety and immunogenicity of the vaccine in these participants over a 12-week period, with a follow-up safety assessment at 6 months.
Who can participate
Age range18 Years – 69 Years
SexALL
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Inclusion criteria
✓. Have received pentavalent botulinum toxoid (or pentavalent botulinum toxoid and rBV A/B) for occupational protection under BB IND 0161 (or BB-IND-0161 and IND 015155)
✓. Are 18 to 69 years old at the time of consent
✓. Are healthy and have an acceptable medical history (defined as individuals who are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, infective, muscular, infectious, rheumatic, immunological, or psychiatric diseases, as determined at screening) that will not interfere with the objectives of the study
✓. Meet the participant suitability requirements and recommendations for source plasma donors
✓. Participants of childbearing potential:
✓. To be considered of non-childbearing potential, participants must be menopausal (no menstrual period for at least 12 months prior to screening) or be surgically sterile
✓. Are able to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by the appropriate Institutional Review Board (IRB), and have agreed to abide by the study restrictions and return for the required assessments
✓. Agree to complete the participant home diary on a daily basis for 7 days post vaccination, as well as to report any severe adverse events (AEs) and serious AEs (SAEs), including serious new onset chronic illnesses (NOCIs) and concomitant medications during the study period
Exclusion criteria
✕. Are pregnant or nursing
What they're measuring
1
Proportion of Subjects Achieving Equal to or Greater Than 4-Fold Increase in Neutralizing Antibody Concentration (NAC)
✕. Have a history of laboratory evidence of syphilis, acquired immunodeficiency syndrome, Creutzfeldt-Jakob disease, or infection with human immunodeficiency viruses (HIV) 1 or 2, human T-cell lymphotropic virus 1, hepatitis B virus (HBV), or hepatitis C virus (HCV)
✕. Have had a prior severe (Grade 3 or higher) local or severe (Grade 3 or higher) systemic reaction to last immunization with PBT
✕. Have had a prior severe immediate hypersensitivity reaction or severe systemic reaction on Day 0 to last vaccination with rBV A/B
✕. Have known allergy to aluminum, yeast, or other components of the vaccine
✕. Have donated one or more units of blood or undergone plasmapheresis within 49 days prior to enrollment
✕. Have received a blood product or immunoglobulin within 6 months prior to enrollment or plans to receive such products during the study period (exclusive of returned red blood cells as part of the plasmapheresis procedure). For participants who choose to donate plasma, this will apply until their last plasma donation or at the Week 12 visit (whichever occurs last)
✕. Have received licensed nonliving vaccine within 14 days prior to enrollment, or licensed live vaccine within 60 days prior to enrollment