Efficacy of Tremacamra, a Soluble Intercellular Adhesion Molecule 1, for Experimental Rhinovirus Infection
| Autor: | Eugene McNally, Margaret T. Wecker, Frederick G. Hayden, Roger St. George, Theodore J. Witek, Ronald B. Turner, Birgit Winther, Gerhardt Pohl |
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| Rok vydání: | 1999 |
| Předmět: |
Adult
Male medicine.medical_specialty Rhinovirus Common Cold Enzyme-Linked Immunosorbent Assay Mucous membrane of nose Antibodies Viral medicine.disease_cause Placebo Severity of Illness Index Gastroenterology Antibodies law.invention Double-Blind Method Randomized controlled trial Neutralization Tests law Internal medicine medicine Humans Seroconversion Administration Intranasal business.industry Interleukin-8 Common cold General Medicine Middle Aged Intercellular Adhesion Molecule-1 medicine.disease Virus Shedding Solutions Nasal Mucosa Immunology Chemoprophylaxis Female Nasal administration Powders business |
| Zdroj: | JAMA. 281:1797 |
| ISSN: | 0098-7484 |
| DOI: | 10.1001/jama.281.19.1797 |
| Popis: | ContextAttachment of most rhinovirus subtypes to cells depends on a cellular receptor, the intercellular adhesion molecule 1 (ICAM-1). A recombinant soluble ICAM-1 (tremacamra, formerly BIRR 4) has shown possible efficacy in early studies.ObjectiveTo determine the efficacy and safety of intranasal administration of tremacamra in experimental rhinovirus colds in humans.DesignFour randomized, double-blind, placebo-controlled trials conducted in January to March 1996.Setting and SubjectsVolunteers between the ages of 18 and 60 years who had an antibody titer of 1:4 or less to the challenge virus. Subjects were isolated in a hotel room during study days 0 to 8; symptoms were recorded through day 14. A total of 198 subjects were randomized, of whom 196 received drug or placebo and were included in the safety analysis. A total of 177 subjects were included in the efficacy analysis.InterventionsTremacamra or placebo was given beginning 7 hours before inoculation with rhinovirus type 39 (preinoculation studies) or 12 hours after (postinoculation studies). Tremacamra as an inhaled solution or as a powder (each given preinoculation and postinoculation for a total of 4 studies) and placebo were given in 6 doses at 3-hour intervals daily during days 1 through 7. Recipients of active treatment received 367 µg of tremacamra per nostril per dose for a total of 4.4 mg/d.Main Outcome MeasuresEffect of tremacamra on infection, as determined by virus isolation and seroconversion, and on illness, as determined by symptom scores, clinical colds, and nasal mucus weights. Treatment-by-study interaction was not significant, so results were pooled for the main analysis.ResultsA total of 88 (92%) of the 96 subjects in the placebo groups and 69 (85%) of the 81 subjects in the active treatment groups were infected (P=.19). For placebo vs tremacamra, respectively, the total symptom score (± 95% confidence interval [CI]) was 17.6 (± 2.7) vs 9.6 (± 2.9), the proportion of clinical colds was 64/96 (67% ± 9%) vs 36/81 (44% ± 11%), and the nasal mucus weight was 32.9 (± 8.8) g vs 14.5 (± 9.4) g (P |
| Databáze: | OpenAIRE |
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