Summary
Background
Availability of a safe smallpox vaccine may be necessary under certain circumstances. Use of the old life virus vaccine was associated with serious adverse events, particularly in the setting of atopic eczema and immunodeficiency. MVA(modified virus Ankara)-BN, a highly attenuated strain of vaccinia virus, was developed for vaccination with improved safety profile.
Methods
A phase 1 study was conducted in 60 subjects without history of smallpox vaccination to gain experience with smallpox vaccination using this strain in healthy and atopic subjects. Healthy subjects, subjects with a history of atopic eczema (AE), subjects with mild active AE and subjects with mild allergic rhinitis without AE were equally allocated in 4 groups. MVA-BN was injected s.c. in a dose of 108 TCID50 twice in a four weeks interval.
Results
No serious or unexpected adverse reactions were reported. All subjects experienced mild to moderate pain and redness at the injection site. Dermatologic examinations did not reveal any unfavourable reactions to the study medication, particularly no sign or exacerbation of eczema for as long as 196 days. All subjects seroconverted after 2 vaccinations and no significant difference in antibody titers between the four different groups was observed.
Conclusions
A good safety profile of the MVA-BN vaccine was shown. The absence of adverse events in subjects with atopic disorders appears promising for the development of a safe smallpox vaccine for patients with AE or other atopic diseases.
A 21-year-old patient experienced asthmatic attacks when cleaning the cage of his budgerigar. Skin tests and radioallergosorbent test were positive to grass pollen and negative for budgerigar feathers and feces. When the food of the bird, a mixture of grain, was tested, a positive reaction to millet was found. Nasal provocation test with millet was positive. Specific immunoglobulin E antibodies against millet were detected in the radioallergosorbent test and in immunoblot analysis. The immunoblot showed specific immunoglobulin E antibodies against a 60-kd protein in millet of birdseed and against a 60-and 36-kd protein in common millet. Immediate-type allergy to millet is rare and occurs mostly as anaphylactic reaction after ingestion of millet but may also occur as asthmatic attack after inhalation of millet.
Poor adherence of patients to long-term acne treatment may lead to unnecessary treatments, increased healthcare costs and reduced quality of life. This study evaluated the effect of supplementary patient education material (SEM) on treatment adherence and satisfaction among acne patients treated with adapalene 0.1%/benzoyl peroxide 2.5% gel (A/BPO) in primary care clinics versus: 1) standard-of-care patient education and 2) more frequent clinic visits. The study included subjects aged 12 years with acne, randomized into three groups to receive once-daily A/BPO for 12 weeks: 1) SEM in addition to standard-of-care patient education with visits at baseline, weeks 6 and 12; 2) standard-of-care patient education only with visits at baseline, weeks 3, 6, 9 and 12; and 3) standard-of-care patient education only with visits at baseline, weeks 6 and 12. Assessments included a subject appreciation questionnaire, a physician questionnaire, and safety. A total of 97 subjects (mean age: 22.5 years) were enrolled. Of those, 82 subjects (84.5%) completed the study. The SEM group showed better adherence compared with more visits or A/BPO alone (63.1%, 48.2% and 56.5%, respectively). Also, the SEM group had more subjects with >75% adherence (45%, 30.4%, and 25%). According to the subjects, the SEM was helpful to adhere to the treatment, better use the product, and better manage skin irritation. All physicians were satisfied with the SEM and 90% would consider using it in their practice. Fewer treatment-related adverse events were reported in the SEM group. SEM may improve adherence to topical treatment of acne and consequently improve efficacy, cost and quality of life in the long term.
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