A Phase 2 interventional study of rBV A/B in Botulism, sponsored by California Department of Public Health. Completed at 2 sites in United States. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by California Department of Public Health · Phase 2, Interventional, and Other
Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine A/B (rBV A/B) for the production of BabyBIG in volunteers previously immunized with the pentavalent botulinum (PBT) toxoid. This study is designed to determine neutralizing antibody levels for botulinum toxin types A and B in healthy subjects who were previously immunized with the PBT for occupational protection and who receive the rBV A/B. Subjects with titers of the neutralizing antibodies against the toxins would be candidates for plasma donation for BabyBIG production.
20 studies on the registry are indexed under Botulism; 3 are open to participants now.
This study's enrollment of 45 is above the median of 29 across 14 interventional studies indexed under Botulism.
Browse Botulism studies →California Department of Public Health is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: rBV A/B
Drug page: Recombinant botulinum vaccine A/B
rBV A/B injections will consist of a single 40 µg injection of total antigen (20 µg of Antigen A and 20 µg of Antigen B) adsorbed to 0.2% (wt/vol) Alhydrogel™, in a total dose volume of 0.5 mL. The vaccine will be administered by intramuscular injection in the deltoid muscle, preferably in the nondominant arm.
Four-Fold Increase in Neutralizing Antibody Concentration (NAC)
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
Three-Fold Increase in Neutralizing Antibody Concentration (NAC)
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
Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve
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
Collected Plasma Volume
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
| Milestone | Initial Safety and Immunogenicity (Part 1) | Safety, Immunogenicity, and Plasma Collection (Part 2) |
|---|---|---|
| Started | 8 | 37 |
| Completed | 8 | 37 |
| Not completed | 0 | 0 |
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).
| proportion of participants | Initial Safety and Immunogenicity (Part 1) | Safety, Immunogenicity, and Plasma Collection (Part 2) |
|---|---|---|
| Type A | 0.75 | 0.84 |
| Type B | 0.75 | 0.89 |
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)
| proportion of participants | Initial Safety and Immunogenicity (Part 1) | Safety, Immunogenicity, and Plasma Collection (Part 2) |
|---|---|---|
| Type A | 0.75 | 0.95 |
| Type B | 0.75 | 0.89 |
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.
| proportion of participants | Initial Safety and Immunogenicity (Part 1) | Safety, Immunogenicity, and Plasma Collection (Part 2) |
|---|---|---|
| Type A | 0.75 | 0.95 |
| Type B | 0.88 | 0.89 |
Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis in Part 2.
| mL | Initial Safety and Immunogenicity (Part 1) | Safety, Immunogenicity, and Plasma Collection (Part 2) |
|---|---|---|
| Collected Plasma Volume | — | 13463.3 ± 4440.5 |
Collected over Six months following rBV A/B administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Initial Safety and Immunogenicity (Part 1) | — | 0/8 (0%) | 8/8 (100%) |
| Safety, Immunogenicity, and Plasma Collection (Part 2) | — | 0/37 (0%) | 34/37 (91.9%) |
| Event | Initial Safety and Immunogenicity (Part 1) | Safety, Immunogenicity, and Plasma Collection (Part 2) |
|---|---|---|
| Injection site pain*General disorders | 6/8 | 15/37 |
| Injection site erythema*General disorders | 5/8 | 19/37 |
| Injection site swelling*General disorders | 3/8 | 18/37 |
| Procedural complication*Injury, poisoning and procedural complications | 0/8 | 14/37 |
| Injection site pruritus*General disorders | 3/8 | 9/37 |
| Malaise*General disorders | 0/8 | 5/37 |
| Haematocrit decreasedInvestigations | 0/8 | 5/37 |
| Headache*Nervous system disorders | 0/8 | 5/37 |
| LymphopeniaBlood and lymphatic system disorders | 1/8 | 0/37 |
| NeutropeniaBlood and lymphatic system disorders | 1/8 | 0/37 |
| Age, Continuous(years) | Initial Safety and Immunogenicity (Part 1) | Safety, Immunogenicity, and Plasma Collection (Part 2) | Total |
|---|---|---|---|
| Mean | 50.3 ± 13.5 | 44.0 ± 10.7 | 45.1 ± 11.3 |
| Sex: Female, Male(Participants) | Initial Safety and Immunogenicity (Part 1) | Safety, Immunogenicity, and Plasma Collection (Part 2) | Total |
|---|---|---|---|
| Female | 3 | 20 | 23 |
| Male | 5 | 17 | 22 |
The record gives a start of Feb 2013, a primary completion of Jun 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2017, 1 year 8 months after primary completion. A results delay was requested in Sep 2016.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Recombinant botulinum vaccine A/B
California Department of Public Health