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W Paul Glezen

Publications and source records attributed to W Paul Glezen.

At least 19 recordsLinked to original sources

Asthma, influenza, and vaccination.

Exacerbations of asthma in children are usually triggered by virus infections. Many different respiratory viruses are associated with these exacerbations, but influenza viruses are frequently associated with those requiring hospitalization and are the only ones for which specific treatment and prophylaxis are available. Current studies have shown that influenza vaccines are safe for patients with asthma. The efficacy of inactivated influenza vaccines in preventing exacerbations of asthma has been questioned. The live attenuated influenza vaccine has been licensed recently in the United States, and studies have shown it to be safe and protective. A direct comparison of the inactivated and live attenuated influenza vaccines in children with asthma demonstrated superior protection by the latter. Live attenuated influenza vaccine, given by nasal spray, is better accepted by children for annual vaccination and is easier to administer. Universal vaccination of all children in school-based clinics will facilitate control of epidemic influenza and provide an infrastructure for control of future influenza pandemics.

Administration, Intranasal↗

Herd protection against influenza.

Mortality and hospitalization rates due to influenza have risen despite increasing vaccine coverage for the most vulnerable population; however, those most vulnerable to complications and death are the least likely to respond to the vaccine. New strategies for influenza control are needed and indirect effectiveness (herd protection) has been demonstrated for several currently used vaccines - rubella, H. influenzae type b, pneumococcus varicella and hepatitis A. The Japanese schoolchildren program provided proof of concept of indirect effectiveness of influenza vaccine. The Central Texas field trial has demonstrated significant herd protection of adults utilizing the live, attenuated influenza vaccine (LAIV) to children. Immunization of <20% of children at the intervention site resulted in an 8-18% reduction of medically attended acute respiratory illness in adults compared to rates in the comparison sites. LAIV given by nasal spray is efficacious against matched and poorly matched prevalent strains, easy to administer and readily accepted by children for annual immunization. School-based clinics could provide a platform for rapid deployment of vaccine accessible to all segments of the population. This strategy could be critical for control of pandemic influenza.

Adult↗

Influenza control.

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Ambulatory Care↗

Medically attended pediatric influenza during the resurgence of the Victoria lineage of influenza B virus.

OBJECTIVES: During the 2002-2003 season, a new variant of influenza B co-circulated with influenza A viruses. This study examines the characteristics and outcomes of children with influenza A and B virus infection vs. other acute respiratory illnesses. METHODS: A retrospective chart review was performed on children with laboratory-confirmed influenza infection, and influenza negative acute respiratory illnesses that prompted a hospital visit. RESULTS: Children with influenza were more often previously healthy and presenting with upper respiratory symptoms, while influenza negative patients typically had underlying medical conditions, and lower respiratory tract disease. Children with influenza B were older, were more likely to be in school, and presented with myositis more frequently than those with influenza A. A third of children with influenza A, and 42% with influenza B required hospitalization. The highest hospitalization rates were in infants under one year. No healthy children, and only 15% of those with chronic medical problems, had received influenza vaccine. Vaccine efficacy was estimated to be 82.6%. CONCLUSIONS: Most children with influenza were previously healthy. Overall, a third of children with influenza required hospitalization. Influenza A and B were clinically indistinguishable, except for older age and higher incidence of myositis in patients with influenza B. Influenza vaccine coverage in both healthy and high-risk children was low.

Adolescent↗

A response to strategy #2: streamlining the regulatory process.

Regulatory burden has contributed to the decline in the production of vaccines in the United States. Production of influenza virus vaccine is perilously limited at a critical period when vulnerable populations are increasing and the threat of a pandemic is looming. Regulatory bodies must work with manufacturers to facilitate implementation of new production practices, to ensure steady expansion of the supply of safe and effective vaccines.

Drug and Narcotic Control↗

A personnel time-motion study of intranasal influenza vaccination in healthy children.

Vaccinating millions of Americans depends, in part, on short vaccination times. During two intranasal influenza vaccine trials, times for six vaccination steps were recorded for 497 children. The total of mean times for the steps was 115 s, almost half spent explaining the vaccine and intranasal delivery. Intranasal influenza vaccination time showed little variation by patient age, was comparable to reported intramuscular vaccination times, and was a small fraction of the visit time. Total family visit time decreased by 64 s if the youngest child was receiving a second dose. Alternative delivery systems (e.g., group visits) are needed to take advantage of short vaccination times.

Administration, Intranasal↗

Herd immunity in adults against influenza-related illnesses with use of the trivalent-live attenuated influenza vaccine (CAIV-T) in children.

Highest attack rates for influenza occur in children. Immunization of schoolchildren with inactivated influenza vaccine in Michigan and Japan was associated with decreased morbidity and mortality, respectively, in older community contacts. An open-labeled, non-randomized, community-based trial in children with the cold adapted influenza vaccine, trivalent (CAIV-T) was initiated to determine the coverage necessary to reduce spread of influenza in the community. Age-specific baseline rates of medically attended acute respiratory illness (MAARI) for Scott and White Health Plan (SWHP) members at intervention (Temple and Belton) and comparison communities (Waco, Bryan, and College Station) were obtained in 1997-1998. During three subsequent vaccination years, 4298, 5251 and 5150 children received one dose per season of CAIV-T. Vaccinees represented 20-25% of the age-eligible children. Age-specific MAARI rates were compared for SWHP members in the intervention and comparison sites during the influenza outbreaks. Baseline age-specific MAARI rates per 100 persons for the influenza season were comparable between the intervention and comparison communities. In the subsequent three influenza seasons, the age groups 35-44, 45-54, 55-65 and >64 years experienced reductions in MAARI rates in the intervention communities. In adults > or =35 years of age, significant reductions in MAARI of 0.08 (95% CI: 0.04, 0.13), 0.18 (95% CI: 0.14, 0.22) and 0.15 (95% CI: 0.12, 0.19), were observed in the influenza seasons for vaccination years 1, 2 and 3, respectively. No consistent reduction in MAARI rates was detected in the younger age groups. Vaccination of approximately 20-25% of children, 1.5-18 years of age in the intervention communities resulted in an indirect protection of 8-18% against MAARI in adults > or =35 years of age.

Adolescent↗

Safety of influenza vaccination during pregnancy.

OBJECTIVE: The purpose of this study was to evaluate the safety of influenza vaccine that is administered in the second or third trimester of gestation. STUDY DESIGN: A retrospective electronic database search of 5 influenza seasons (July 1, 1998, to June 30, 2003) was performed at a large multispecialty clinic in Houston, Texas. Immunization rates were calculated, and outcomes of pregnancy were compared between a cohort of healthy women who received influenza vaccine and a control group of healthy unvaccinated women who were matched by age, month of delivery, and type of medical insurance. RESULTS: Among 7183 eligible mother-infant pairs, only 252 pregnant women (3.5%) received the influenza vaccine. Women with medical insurance were more likely to be vaccinated, although the rates for women with chronic underlying conditions were similar to those of healthy women, regardless of insurance status. The mean gestational age at the time of influenza vaccination was 26.1 weeks (range, 14-39 weeks). No serious adverse events occurred within 42 days of vaccination, and there was no difference between the groups in the outcomes of pregnancy (including cesarean delivery and premature delivery) and infant medical conditions from birth to 6 months of age. CONCLUSION: Influenza vaccine that was administered in the second or third trimester of gestation was safe in this study population.

Adult↗

Respiratory viral infections in patients with chronic, obstructive pulmonary disease.

OBJECTIVES: The purpose of the present study was to apply reverse transcription-PCR (RT-PCR) assays to clinical specimens collected from patients with acute respiratory illness and chronic obstructive pulmonary disease (COPD). METHODS: One hundred and ninety-four samples from two different study cohorts were analysed using RT-PCR assays for picornaviruses, coronaviruses 229E and OC43, influenza A and B viruses, respiratory syncytial virus, parainfluenza types 1-3 viruses, and human metapneumovirus and a PCR assay for adenoviruses. The results were added to results obtained previously using cell culture and serologic methods. RESULTS: RT-PCR assays identified an additional 35 respiratory virus-associated illnesses not identified previously by cell culture or serology (n=46). Picornaviruses and coronaviruses were the most common viral infections identified only by RT-PCR. Overall, 41.8% of the acute respiratory illnesses evaluated were associated with a respiratory virus infection, with picornaviruses, coronaviruses and influenza viruses being the most common infections recognized. No human metapneumovirus infections were identified by RT-PCR assay. CONCLUSIONS: Respiratory viral infections are commonly associated with acute respiratory illness in COPD patients, and the use of RT-PCR assays significantly increases the ability to diagnose these infections.

Aged↗

Live attenuated influenza vaccine, trivalent, is safe in healthy children 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in a community-based, nonrandomized, open-label trial.

OBJECTIVE: Influenza-associated deaths in healthy children that were reported during the 2003-2004 influenza season heightened the public awareness of the seriousness of influenza in children. In 1996-1998, a pivotal phase III trial was conducted in children who were 15 to 71 months of age. Live attenuated influenza vaccine, trivalent (LAIV-T), was shown to be safe and efficacious. In a subsequent randomized, double-blind, placebo-controlled LAIV-T trial in children who were 1 to 17 years of age, a statistically significant increase in asthma encounters was observed for children who were younger than 59 months. LAIV-T was not licensed to children who were younger than 5 years because of the concern for asthma. We report on the largest safety study to date of the recently licensed LAIV-T in children 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in a 4-year (1998-2002) community-based trial that was conducted at Scott & White Memorial Hospital and Clinic (Temple, TX). METHODS: An open-label, nonrandomized, community-based trial of LAIV-T was conducted before its licensure. Medical records of all children were surveyed for serious adverse events (SAEs) 6 weeks after vaccination. Health care utilization was evaluated by determining the relative risk (RR) of medically attended acute respiratory illness (MAARI) and asthma rates at 0 to 14 and 15 to 42 days after vaccination compared with the rates before vaccination. Medical charts of all visits coded as asthma were reviewed for appropriate classification of events: acute asthma or other. We evaluated the risk for MAARI (health care utilization for acute respiratory illness) 0 to 14 and 15 to 42 days after LAIV-T by a method similar to the postlicensure safety analysis conducted on measles, mumps, and rubella and on diphtheria, tetanus, and whole-cell pertussis vaccines. RESULTS: All children regardless of age were administered a single intranasal dose of LAIV-T in each vaccine year. In the 4 years of the study, we administered 18780 doses of LAIV-T to 11096 children. A total of 4529, 7036, and 7215 doses of LAIV-T were administered to children who were 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age, respectively. In vaccination years 1, 2, 3, and 4, we identified 10, 15, 11, and 6 SAEs, respectively. None of the SAEs was attributed to LAIV-T. In vaccination years 1, 2, 3, and 4, we identified 3, 2, 1, and 0 pregnancies, respectively, among adolescents. All delivered healthy infants. The RR for MAARI from 0 to 14 and 15 to 42 days after LAIV-T was assessed in vaccinees during the 4 vaccine years. Compared with the prevaccination period, there was no significant increase in risk in health care utilization attributed to MAARI from 0 to 14 and 15 to 42 days after vaccination in children who were 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in the 4 vaccine years. In children who were 18 months to 4 years of age, there was no significant increase in the risk in health care utilization for MAARI, MAARI subcategories (otitis media/sinusitis, upper respiratory tract illness, and lower respiratory tract illness), and asthma during the 0 to 14 days after vaccination compared with the prevaccination period. No significant increase in the risk in health care utilization for MAARI, MAARI subcategories, and asthma was detected when the risk period was extended to 15 to 42 days after vaccination, except for asthma events in vaccine year 1. A RR of 2.85 (95% confidence interval [CI]: 1.01-8.03) for asthma events was detected in children who were 18 months to 4 years of age but was not significantly increased for the other 3 vaccine years (vaccine year 2, RR: 1.42 [95% CI: 0.59-3.42]; vaccine year 3, RR: 0.47 [95% CI: 0.12-1.83]; vaccine year 4, RR: 0.20 [95% CI: 0.03-1.54]). No significant increase in the risk in health care utilization for MAARI or asthma was observed in children who were 18 months to 18 years of age and received 1, 2, 3, or 4 annual sequential doses of LAIV-T. Children who were 18 months to 4 years of age and received 1, 2, 3, or 4 annual doses of LAIV-T did not experience a significant increase in the RR for MAARI 0 to 14 days after vaccination; this was also true for children who were 5 to 9 and 10 to 18 years of age. CONCLUSIONS: We observed no increased risk for asthma events 0 to 14 days after vaccination in children who were 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age, In vaccine year 1, children who were 18 months to 4 years of age did have a significantly higher RR (2.85; 95% CI: 1.01-8.03) for asthma events 15 to 42 days after vaccination. In vaccine year 2, the formulation of LAIV-T was identical to the vaccine formulation used in vaccine year 1; however, in children who were 18 months to 4 years of age, no statistically significant increased risk was detected for asthma events 15 to 42 days after vaccination. Similarly, in vaccine years 3 and 4, children who were 18 months to 4 years of age did not have a statistically significant increased risk for asthma events 15 to 42 days after vaccination. Also, LAIV-T did not increase the risk for asthma in children who received 1, 2, 3, or 4 annual doses of LAIV-T. Although the possibility for a true increased risk for asthma was observed in 1 of 4 years in children who were 18 months to 4 years at 15 to 42 days after vaccination, it is more likely that the association is a chance effect because of the 190 comparisons made without adjustment for multiple comparisons. We conclude that LAIV-T is safe in children who are 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age. The hypothesis that LAIV-T is associated with an increase in asthma events in children who are younger than 5 years is not supported by our data. Reassessment of the lower age limit for use of LAIV-T in children is indicated.

Administration, Intranasal↗

Direct and total effectiveness of the intranasal, live-attenuated, trivalent cold-adapted influenza virus vaccine against the 2000-2001 influenza A(H1N1) and B epidemic in healthy children.

BACKGROUND: The efficacy of the intranasal, live-attenuated, trivalent cold-adapted influenza virus vaccine (CAIV-T) against influenza A(H3N2) and B infections in healthy persons is established, but its effectiveness against natural influenza A(H1N1) infection is unknown. OBJECTIVE: To assess the effectiveness of CAIV-T in healthy children during the 2000-2001 influenza A(H1N1) and B epidemic. DESIGN: Community-based, nonrandomized, open-label trial from August 1998 through April 2001. SETTING: Intervention and comparison communities in central Texas. PARTICIPANTS: Healthy children, aged 1.5 to 18 years, from the intervention communities received a single dose of CAIV-T at least 1 time or more in 1998, 1999, and/or 2000. MAIN OUTCOME MEASURES: The incidence of medically attended acute respiratory illnesses during the 2000-2001 influenza epidemic was compared in 3794 health plan CAIV-T recipients with age-eligible, health plan nonrecipients in the intervention communities for direct effectiveness (n = 9325), and with those in the 2 comparison communities for total effectiveness (n = 16,264). RESULTS: The 2281 CAIV-T recipients in 2000 had significant direct protection against medically attended acute respiratory illness of 18% to 20% during the biphasic influenza A(H1N1) and B epidemic, and 17% to 26% during influenza A(H1N1) predominance. The 931 recipients of CAIV-T in 1999 containing influenza A/Beijing/262/95(H1N1) and B/Beijing/184/93-like viruses had persistent heterovariant protection against the 2000-2001 influenza A/New Caledonia/20/99(H1N1) and B/Sichuan/379/99 variants. The 616 recipients of a single CAIV-T dose in 1999 only, including those younger than 5 years with no prior natural exposure to influenza A(H1N1) viruses, showed persistent protection. CONCLUSION: Healthy children who received CAIV-T in 2000 or 1999 were protected against new variants of influenza A(H1N1) and B in the 2000-2001 influenza epidemic.

Acute Disease↗

The changing epidemiology of respiratory syncytial virus and influenza: impetus for new control measures.

BACKGROUND: Influenza and respiratory syncytial virus (RSV) are the most important causes of medically attended acute respiratory illnesses. Medical encounters for acute respiratory illness peak each winter, coinciding with the peak of influenza activity. RSV is the most important cause of hospitalization of infants for acute lower respiratory illness. METHODS: Surveillance of influenza and RSV have been maintained in Houston since 1974. Hospitalization rates during that period were compared with national data. U.S. influenza mortality rates and population dynamics were reviewed. RESULTS: The number of deaths attributed to influenza in the United States have increased from approximately 15,000 per year for the period from 1972 through 1984 to >50,000 from 1990 to 1999. RSV hospitalization rates for infants have more than doubled during the same period. Influenza epidemics have tended to occur earlier in Texas, with epidemic disease evident in early November in 3 of the last 4 years. CONCLUSIONS: Population dynamics with increased population density and urbanization probably are responsible for worsening of epidemics of the major respiratory viruses. New approaches to control will be necessary to reduce impact of these infections. These include earlier availability of influenza vaccine each autumn and use of antivirals and new vaccines for RSV.

Adolescent↗

Cold-adapted, live attenuated influenza vaccine.

The recently licensed cold-adapted, live attenuated influenza vaccine (CAIV-T, FluMist, MedImmune Vaccines Inc.) has the potential to enhance control of epidemic influenza. The intranasal vaccine has proven safety and efficacy. Regulatory constraints and cost of CAIV-T have hampered the introduction of the vaccine in the first year. Unwarranted concern about possible transmission of the virus from vaccine recipients to immunocompromised patients limited use in healthcare personnel. The intense influenza A(H3N2) epidemic of 2003-2004 has underscored the necessity of supplementing current efforts to control influenza. Over 120 deaths have been documented in children - the majority of which have been previously healthy. Use of CAIV-T in children will not only decrease the risk of serious disease, but also dampen the spread of the virus in the community and reduce exposure of patients who are at high risk of complications and death.

Adolescent↗

New vaccines for old diseases: trivalent cold-adapted influenza vaccine.

Schoolchildren regularly have the highest influenza attack rates. Schoolchildren also are accessible for vaccination; school-based vaccine clinics can facilitate delivery of vaccine to a high proportion of children in a short period of time. CAIV-T has advantages for immunization of this group due to the effectiveness of a single dose, ease of administration, and ready acceptance by children. Modeling of control for an influenza epidemic by Longini et al. has shown vaccination of 70% of school children would dampen epidemics and significantly reduce the exposure of vulnerable people in the community. The goal of the central Texas trial is to demonstrate this effect in the field. Universal childhood immunization could be an important supplement to current control efforts. Vaccine coverage with TIV has leveled off since 1997; no progress toward the Healthy People 2010 goals of 90% coverage has been made after 4 years in the new decade. The number of excess deaths is expected to double within the next 25 years if control methods are not intensified. CAIV-T may become an important adjunct to control measures and can facilitate influenza pandemic preparedness.

Child↗

Control of influenza.

Influenza is the classic emerging infection. Despite the availability of relatively inexpensive vaccines and specific treatments, influenza is the least controlled vaccine-preventable disease. Vaccination coverage of high-risk patients has improved, but all-cause mortality attributable to influenza continues to increase. A supplemental strategy is to vaccinate the principal disseminators of influenza in the community: school children and working adults. The availability of the live, attenuated, cold-adapted nasal spray vaccine should facilitate this goal.

Administration, Inhalation↗

Estimating efficacy of trivalent, cold-adapted, influenza virus vaccine (CAIV-T) against influenza A (H1N1) and B using surveillance cultures.

The authors report on a community-based, nonrandomized, open-label study, conducted during the 2000-2001 influenza season in Temple-Belton, Texas, of the protective effectiveness of trivalent, cold-adapted, influenza virus vaccine (CAIV-T) in children aged 18 months-18 years. The dominant circulating strains in 2000-2001 were influenza A/New Caledonia/20/99 (H1N1) and influenza B/Sichuan/379/99. Children had access to CAIV-T during the 1998-1999, 1999-2000, and 2000-2001 influenza seasons. The vaccine included influenza A/Sydney/5/97 (H3N2) and B/Beijing/184/93-like (B/Ann Arbor/l/94) strains in all three seasons. The vaccine included A/Beijing/262/95 (H1N1) in 1998-1999 and 1999-2000, which was replaced by A/New Caledonia/20/99 (H1N1) in 2000-2001. When medically attended acute respiratory illness (MAARI) was used as the outcome, the protective effectiveness for children vaccinated in 2000 was 18% (95% confidence interval (CI): 11, 25). Based on a combination of a validation sample of surveillance cultures and the MAARI outcome, protective efficacy against combined influenza A (H1N1) and B was 79% (95% CI: 51, 91). The efficacy estimate, after accounting for missing influenza culture status, against influenza A (H1N1) alone was 92% (95% CI: 42, 99) and against a new variant of influenza B alone was 66% (95% CI: 9, 87). CAIV-T provides substantial protection against a mixture of influenza A (H1N1) and B. Results demonstrate the powerful potential of using validation sets for outcomes in vaccine field studies.

Adolescent↗