Transcutaneous Immunization With an Attenuated Listeria Monocytogenes Vector Vaccine (NCT01311817) | Clinical Trial Compass
CompletedPhase 1
Transcutaneous Immunization With an Attenuated Listeria Monocytogenes Vector Vaccine
United States8 participantsStarted 2011-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
* 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.
Exclusion Criteria:
* 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 (tho…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.