Healthy VolunteersPhase 1NCT01311817
Transcutaneous Immunization With an Attenuated Listeria Monocytogenes Vector Vaccine
A Phase 1 study testing BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein) in people with Healthy Volunteers, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This project is a pilot safety and immunogenicity study of transcutaneous vaccination with live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult 18-55 years old, male or female.
- Adequate venous access by inspection for frequent blood draws.
- Must have normal physical exam and laboratory values within the normal range for age/gender in screening studies (see details below).
- Be willing to return for 3 vaccinations, and the needed follow-up visits.
- Not pregnant (WOCBP have pregnancy testing prior to vaccination, on a standard schedule over the course of the study, and must use contraception).
- Non-smokers (altered immunity).
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- Body mass index (BMI) less than or equal to 32.5 (the obese have impaired responses to some vaccines).
- Normal skin exam.
- Volunteers must be feeling well and be afebrile (T<99.5) at the time of vaccination.
Who cannot join
- History of allergy to any penicillin (including penicillin G, penicillin V, ampicillin, amoxicillin) or sulfa drugs (trimethoprim/sulfamethoxazole is the second line agent for therapy of listeriosis).
- Any chronic medical illness or problem requiring chronic medical care. Exceptions:
- Subjects on one antihypertensive prescribed for essential hypertension, with seated BP in the normal range at screening will be accepted. These are immunologically normal adults and we do not believe treated essential hypertension as a single illness puts these individuals at any greater risk than other healthy adults.
- Subjects using only PRN beta agonists for mild asthma, or cold or exercise-induced bronchospams, will be allowed (those with any prior or current inhaled or systemic steroids for asthma are excluded).
- Any chronic or current skin disorder, e.g. eczema, dermatitis, psoriasis, rosacea, or acne. Prescription medications more than 5 years ago for teenage acne without current acne on exam or current use of those medications does not exclude subjects.
- Any acute skin break or problem at the planned vaccination site (deltoid).
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- Upper extremity lymphedema, deformity (e.g. large burn or poorly-healed fracture), swelling or vascular abnormality on exam. A history of a distant isolated arm, wrist or hand fracture (more than 5 years earlier) with no residual functional deficit or visible deformity will not exclude a subject.
- History of allergy to medical bandages, tape, or adhesives (a Tegaderm patch is used for application.)
- No history of bleeding disorder, or anticoagulant medications. (The protocol has an optional skin biopsy).
- Pregnancy, attempting pregnancy, or unwillingness to use medically acceptable contraception for entire study period if sexually active. Women of childbearing potential will have serum pregnancy testing. Women who are menopausal (over 50 years of age with no menses for more than one year) or surgically sterilized are not considered of child-bearing potential and will not require pregnancy testing or contraception. Acceptable contraception includes: condoms/spermicide, prescription hormonal contraceptive pills, patches, rings, and implants; IUDs.
- Any type of chronic prescription medication use for any reason, including acne or skin conditions. Exceptions: oral contraceptives, depo contraceptives, patch contraceptives, one antihypertensive agent is allowed, if BP is normal on exam as noted above.
- History of keloid scars, or poor wound healing.
- Previous splenectomy or abdominal procedure where splenectomy was possibly performed - e.g. laparotomy for trauma. (Not a known risk factor for listeriosis, but might conceivably result in more serious illness, or alter immune responses to a bacterial pathogen).
- Any biomedical implants: cranial plates, joint prostheses, bone screws, pacemakers, CNS clips, and heart valves. (Exceptions: K wires or 3 or fewer dental implants more than 2 years post implantation in an otherwise healthy individual with no functional deficit or deformity will not exclude an individual.)
- Mitral valve click or prolapse or heart murmur beyond a typical flow murmur.
- Chronic pain syndromes like headaches or back pain requiring use (more than once per week) of over-the-counter medications like Tylenol or NSAIDs.
- Elevated iron stores, evidence of chronic hemolysis such as abnormal blood smear, elevated transferrin or transferrin saturation >50% (Iron overload predisposes to listeriosis and asymptomatic elevated iron level may indicate early iron overload state, i.e. hemochromatosis).
- Any evidence of immunosuppressive illness (e.g. HIV or malignancy) or seropositive for HIV or hepatitis B (sAg positive) or C, or history of frequent infections especially sino-pulmonary, skin or soft tissue or GI infections. Hepatitis B serologies consistent with vaccination or resolved prior infection (surface antibody positive and surface antigen negative) is not a reason for exclusion.
- Subjects who live with immunosuppressed individuals, children under 4 years of age, or people with chronic skin disorders in the household are excluded.
- Alcohol or substance abuse (immunosuppressive affects of alcohol and altered immune responses) by history. Occasional recreational use of marijuana, or social alcohol use are not exclusion criteria. Drug testing is not performed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Transcutaneous Immunization With actA/plcB-Deleted Listeria Monocytogenes Expressing Influenza A Nucleoprotein (BMB72) and Cholera Toxin Adjuvant
This project is a pilot safety and immunogenicity study of transcutaneous vaccination with live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin. Transcutaneous vaccination is needle-less application of materials directly to the skin. Healthy adult volunteers (4 per group) will receive either:
- Saline (placebo)
- Cholera toxin adjuvant alone
- L. monocytogenes BMB72 bacteria alone
- L. monocytogenes BMB72 bacteria plus Cholera toxin adjuvant
Vaccine solutions will be applied to the upper deltoid area under a standard Tegaderm dressing. Key primary endpoints include: safety as measured primarily by clinical findings (VS, cutaneous exams, and systemic reactions), and immune responses as measured by serological responses to L. monocytogenes, influenza A nucleoprotein, CT, and IFN gamma ELISPOT responses to listeriolysin and nucleoprotein peptides. Local skin immune responses will be evaluated by skin biopsy in subjects who agree to that (optional). The study will begin with 2 "roll-in" subjects receiving both L. monocytogenes and CT.
- Conditions
- Healthy Volunteers
- Being tested
- BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)Biological
Also called Lot ELH072910
1mL liquid contained in an adhesive skin patch
| Study group | Role | What they receive |
|---|---|---|
| Saline Patch | Placebo comparator | 1mL saline applied to the vaccine patch Receives: Biological: BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein) |
| Bacteria plus CT | Experimental | 0.95mL bacterial vector plus 0.05mL cholera toxin Receives: Biological: BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Safety
Safety is measured primarily by clinical findings (VS, cutaneous exams, and systemic reactions
Measured: 1 year +/-
Immunogenicity
Immune responses are measured by serological responses to L. monocytogenes, influenza A nucleoprotein, cholera toxin, and IFN gamma ELISPOT responses to listeriolysin and nucleoprotein peptides.
Measured: 1 year +/-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth L. Hohmann, MD, Massachusetts General Hospital
- Investigators
- Elizabeth L Hohmann, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311817
- Sponsor's protocol ID
- 2008P-0002296
- Status last verified
- Sep 2015
- First submitted
- 8 Mar 2011
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eypper EH, Johnson PV, Purro EI, Hohmann EL. Transcutaneous immunization of healthy volunteers with an attenuated Listeria monocytogenes vaccine strain and cholera toxin adjuvant. Vaccine. 2013 Jul 11;31(32):3257-61. doi: 10.1016/j.vaccine.2013.05.028. Epub 2013 May 22.
PubMed 23707162
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Immunization With actA/plcB-Deleted Listeria Monocytogenes Expressing Influenza A Nucleoprotein (BMB72) and Cholera Toxin Adjuvant
- ClinicalTrials.gov ID
- NCT01311817
- Acronym / sponsor ID
- 2008P-0002296
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a pilot safety and immunogenicity study of transcutaneous vaccination with live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin. Transcutaneous vaccination is needle-less application of materials directly to the skin. Healthy adult volunteers (4 per group) will receive either:
- Saline (placebo)
- Cholera toxin adjuvant alone
- L. monocytogenes BMB72 bacteria alone
- L. monocytogenes BMB72 bacteria plus Cholera toxin adjuvant
Vaccine solutions will be applied to the upper deltoid area under a standard Tegaderm dressing. Key primary endpoints include: safety as measured primarily by clinical findings (VS, cutaneous exams, and systemic reactions), and immune responses as measured by serological responses to L. monocytogenes, influenza A nucleoprotein, CT, and IFN gamma ELISPOT responses to listeriolysin and nucleoprotein peptides. Local skin immune responses will be evaluated by skin biopsy in subjects who agree to that (optional). The study will begin with 2 "roll-in" subjects receiving both L. monocytogenes and CT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Patch | Placebo comparator | Biological: BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)1mL saline applied to the vaccine patch |
| Bacteria plus CT | Experimental | Biological: BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)0.95mL bacterial vector plus 0.05mL cholera toxin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult 18-55 years old, male or female.
- Adequate venous access by inspection for frequent blood draws.
- Must have normal physical exam and laboratory values within the normal range for age/gender in screening studies (see details below).
- Be willing to return for 3 vaccinations, and the needed follow-up visits.
- Not pregnant (WOCBP have pregnancy testing prior to vaccination, on a standard schedule over the course of the study, and must use contraception).
Key exclusion criteria (20 listed)
- History of allergy to any penicillin (including penicillin G, penicillin V, ampicillin, amoxicillin) or sulfa drugs (trimethoprim/sulfamethoxazole is the second line agent for therapy of listeriosis).
- Any chronic medical illness or problem requiring chronic medical care. Exceptions:
- Any chronic or current skin disorder, e.g. eczema, dermatitis, psoriasis, rosacea, or acne. Prescription medications more than 5 years ago for teenage acne without current acne on exam or current use of those medications does not exclude subjects.
- Any acute skin break or problem at the planned vaccination site (deltoid).
- Upper extremity lymphedema, deformity (e.g. large burn or poorly-healed fracture), swelling or vascular abnormality on exam. A history of a distant isolated arm, wrist or hand fracture (more than 5 years earlier) with no residual functional deficit or visible deformity will not exclude a subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)Also: Lot ELH0729101mL liquid contained in an adhesive skin patch | Biological | Bacteria plus CT, Saline Patch |
Primary outcome
Vaccine Safety
Time frame: 1 year +/-
Safety is measured primarily by clinical findings (VS, cutaneous exams, and systemic reactions
Immunogenicity
Time frame: 1 year +/-
Immune responses are measured by serological responses to L. monocytogenes, influenza A nucleoprotein, cholera toxin, and IFN gamma ELISPOT responses to listeriolysin and nucleoprotein peptides.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Derived from this study: PubMed 23707162Eypper EH, Johnson PV, Purro EI, Hohmann EL. Transcutaneous immunization of healthy volunteers with an attenuated Listeria monocytogenes vaccine strain and cholera toxin adjuvant. Vaccine. 2013 Jul 11;31(32):3257-61. doi: 10.1016/j.vaccine.2013.05.028. Epub 2013 May 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth L Hohmann, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein) in people with Healthy Volunteers, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Safety (time frame: 1 year +/-). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.