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 range18 Years – 55 Years

SexALL

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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…

What they're measuring

Vaccine Safety

Timeframe: 1 year +/-

Immunogenicity

Timeframe: 1 year +/-

Trial details

NCT IDNCT01311817

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07