ABSTRACT
Adenovirus serotypes 4 (ADV-4) and 7 (ADV-7) are important causes of febrile acute respiratory disease (ARD) in US military recruits. Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1 randomized, double-blind, placebo-controlled trial of the live, oral ADV-4 and ADV-7 vaccines made by a new manufacturer to assess their safety and immunogenicity. The adenovirus vaccines were administered orally together in a single dose to thirty subjects. Twenty eight additional subjects received placebo. Subjects were then observed for 8 weeks. The most commonly reported adverse events were nasal congestion (33%), cough (33%), sore throat (27%), headache (20%), abdominal pain (17%), arthralgia (13%), nausea (13%) and diarrhea (13%). None of these rates differed significantly from placebo. The duration of vaccine virus fecal shedding was 7-21 days. Seventy three percent of vaccine recipients seroconverted to ADV-4 (GMT 23.3) while 63% seroconverted to ADV-7 (GMT 51.1) by Day 28. The new ADV-4 and ADV-7 vaccines were safe and induced a good immune response in the study population. Expanded trials for safety and efficacy are in progress.
Subject(s)
Adenoviridae Infections/immunology , Adenoviridae Infections/prevention & control , Adenoviridae/immunology , Viral Vaccines/adverse effects , Viral Vaccines/therapeutic use , Adenoviridae Infections/virology , Administration, Oral , Adolescent , Adult , Antibodies, Viral/analysis , Antibodies, Viral/biosynthesis , Double-Blind Method , Feces/virology , Female , Humans , Immunization, Secondary , Immunologic Surveillance , Male , Pharynx/virology , Rectum/virology , Reverse Transcriptase Polymerase Chain Reaction , Tablets, Enteric-Coated , Viremia/blood , Viremia/virologyABSTRACT
OBJECTIVE: To survey attendees at community meetings for an emergency research protocol and determine whether these meetings aid participants' understanding and decision to support the proposed emergency research. DESIGN: Postmeeting questionnaire. SETTING: Three community meetings for the PolyHeme study in San Antonio area. SUBJECTS: One hundred fifty community meeting attendees. INTERVENTIONS: PolyHeme research team representatives made a study presentation concerning exception to informed consent regulations. In addition, institutional review board (IRB) members attended these meetings and made a separate presentation about the IRB approval of research and the exception to informed consent in emergency research. The IRB members requested attendees to voluntarily complete an additional Community Consultation Survey assessing demographics, community meeting satisfaction, and impact of the community meeting on their attitudes toward emergency research studies. MEASUREMENTS AND MAIN RESULTS: Feedback to the PolyHeme investigators with their validation questions indicated that 35% of the respondents objected to research without prior consent, but 82% gave approval for the study in the local community; 137 attendees completed the additional Community Consultation Survey. The average score on the adequacy of information provided about the PolyHeme study was 0.58 on a 5-point Likert scale (-2 to +2). Adequacy of IRB background information on human subjects research received an average score of 0.56, and the overall clarity of the information on community consultation was 0.91. Although 80% of respondents felt there was a potential benefit from PolyHeme, <67% would either want to participate or enroll their family members with or without prior consent. CONCLUSIONS: The majority of community meeting attendees understand basic concepts and regulations of emergency research without prior consent. Despite an 82% concurrence with the study in their community, approximately 30% of persons would not willingly choose to participate in emergency research or provide consent for their family members despite knowledge about the process.
Subject(s)
Biomedical Research/organization & administration , Community-Institutional Relations , Congresses as Topic , Emergency Medicine , Adolescent , Adult , Female , Humans , Male , Middle Aged , Surveys and QuestionnairesABSTRACT
BACKGROUND: The influence of hospital design on nosocomial transmission of methicillin-resistant Staphylococcus aureus (MRSA) is unknown. Our hospital's relocation to a new building with radically different ward design allowed us to study this question. Our old hospital facility had open bay wards and intensive care units, and few poorly located sinks for handwashing (bed:sink ratio 4:1). Our new hospital facility had optimized hand-washing geography and distribution of ward beds into mostly single or double rooms (bed:sink ratio 1.3:1). METHODS: We compared the prevalence of MRSA in the 2 institutions by obtaining nasal swabs from all patients on 8 selected wards and intensive care units at 2 time points both before and after the move. In addition, passive surveillance rates of MRSA for all hospitalized patients for 2 years both before and after the move were compared. Hand hygiene practices, although unrelated to the study periods, were directly observed. RESULTS: Eight of 123 patients cultured before the move were MRSA positive, compared to 5 of 138 patients cultured after the move (P=NS). MRSA prevalence determined by passive surveillance of all hospitalized patients before and after the move was also unchanged. An insignificant increase in the frequency of hand-hygiene performance following the move (20% to 23%) was observed. CONCLUSION: Radical facility design changes, which would be permissive of optimal infection control practices, were not sufficient, by themselves, to reduce the nosocomial spread of MRSA in our institution.
