Biomedical subjects

Mary McCauley

Publications and source records attributed to Mary McCauley.

9 recordsLinked to original sources

PubMed2006

Surveillance guidelines for smallpox vaccine (vaccinia) adverse reactions.

CDC and the U.S. Food and Drug Administration rely on state and local health departments, health-care providers, and the public to report the occurrence of adverse events after vaccination to the Vaccine Adverse Event Reporting System. With such data, trends can be accurately monitored, unusual occurrences of adverse events can be detected, and the safety of vaccination intervention activities can be evaluated. On January 24, 2003, the U.S. Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a biologic terrorism event. As part of the DHHS Smallpox Preparedness and Response Program, CDC in consultation with experts, established surveillance case definitions for adverse events after smallpox vaccination. Adverse reactions after smallpox vaccination identified during the 1960s surveillance activities were classified on the basis of clinical description and included eczema vaccinatum; fetal vaccinia; generalized vaccinia; accidental autoinoculation, nonocular; ocular vaccinia; progressive vaccinia; erythema multiforme major; postvaccinial encephalitis or encephalomyelitis; and pyogenic infection of the vaccination site. This report provides uniform criteria used for the surveillance case definition and classification for these previously recognized adverse reactions used during the DHHS Smallpox Preparedness and Response Program. Inadvertent inoculation was changed to more precisely describe this event as inadvertent autoinoculation and contact transmission, nonocular and ocular vaccinia. Pyogenic infection also was renamed superinfection of the vaccination site or regional lymph nodes. Finally, case definitions were developed for a new cardiac adverse reaction (myo/pericarditis) and for a cardiac adverse event (dilated cardiomyopathy) and are included in this report. The smallpox vaccine surveillance case definitions presented in the report can be used in future vaccination programs to ensure uniform reporting guidelines and case classification.

Adverse Drug Reaction Reporting Systems↗

PubMed2005

Adverse events associated with smallpox vaccination in the United States, January-October 2003.

CONTEXT: On January 24, 2003, the US Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (vaccinia) vaccine was administered to federal, state, and local volunteers who might be first responders during a bioterrorism event. OBJECTIVE: To describe results from the comprehensive DHHS smallpox vaccine safety monitoring and response system. DESIGN, SETTING, AND PARTICIPANTS: Descriptive study of adverse event reports from the DHHS smallpox vaccine safety monitoring and response system received between January 24 and October 31, 2003, through the Vaccine Adverse Event Reporting System (VAERS) and the Centers for Disease Control and Prevention. A total of 37,901 volunteers in 55 jurisdictions received at least 1 dose of smallpox vaccine. MAIN OUTCOME MEASURES: Number of vaccinations administered and description of adverse events and reporting rates. RESULTS: A total of 38,885 smallpox vaccinations were administered, with a take rate of 92%. VAERS received 822 reports of adverse events following smallpox vaccination (overall reporting rate, 217 per 10,000 vaccinees). A total of 590 adverse events (72%) were reported within 14 days of vaccination. Nonserious adverse events (n = 722) included multiple signs and symptoms of mild and self-limited local reactions. One hundred adverse events (12%) were designated as serious, resulting in 85 hospitalizations, 2 permanent disabilities, 10 life-threatening illnesses, and 3 deaths. Among the serious adverse events, 21 cases were classified as myocarditis and/or pericarditis and 10 as ischemic cardiac events that were not anticipated based on historical data. Two cases of generalized vaccinia and 1 case of postvaccinial encephalitis were detected. No preventable life-threatening adverse reactions, contact transmissions, or adverse reactions that required treatment with vaccinia immune globulin were identified. Serious adverse events were more common among older revaccinees than younger first-time vaccinees. CONCLUSIONS: Rigorous smallpox vaccine safety screening, educational programs, and older vaccinees may have contributed to low rates of preventable life-threatening adverse reactions. Other rare, clinically significant, or unexpected cardiac adverse events were detected by timely review of VAERS data and intensive clinical case investigation.

Adverse Drug Reaction Reporting Systems↗

PubMed2004

Combination immunotherapy with a CpG oligonucleotide (1018 ISS) and rituximab in patients with non-Hodgkin lymphoma: increased interferon-alpha/beta-inducible gene expression, without significant toxicity.

CpG oligodeoxynucleotides (CpG-ODNs) affect innate and adaptive immune responses, including antigen presentation, costimulatory molecule expression, dendritic cell maturation, and induction of cytokines enhancing antibody-dependent cell-mediated cytotoxicity (ADCC). We conducted a phase 1 study evaluating 4 dose levels of a CpG-ODN (1018 ISS) with rituximab in 20 patients with relapsed non-Hodgkin lymphoma (NHL). Patients received CpG once a week for 4 weeks beginning after the second of 4 rituximab infusions. Adverse events were minimal. Quantitative polymerase chain reaction (PCR) measurements of a panel of genes inducible by CpG-ODN and interferons were performed on blood samples collected before and 24 hours after CpG. A dose-related increase was measured in the expression of several interferon-inducible genes after CpG and correlated with serum levels of 2'-5' oligoadenylate synthetase (OAS), a validated interferon response marker. Genes induced selectively by interferon-gamma (IFN-gamma) were not significantly induced by CpG. In conclusion, we have defined a set of gene expression markers that provide a sensitive measure of biologic responses of patients to CpG therapy in a dose-related manner. Moreover, all the genes significantly induced by this CpG are regulated by type 1 interferons, providing insight into the dominant immune mechanisms in humans. CpG treatment resulted in no significant toxicity, providing rationale for further testing of this exciting combination immunotherapy approach to NHL.

Adult↗

PubMed2004

Immunization coverage levels among 19- to 35-month-old children in 4 diverse, medically underserved areas of the United States.

BACKGROUND: The National Immunization Survey demonstrates that national immunization coverage in 2002 remained near the all-time highs achieved in 2000. However, that survey cannot detect whether coverage is uniformly high within relatively small areas or populations. The measles resurgence in the early 1990s revealed that coverage was low in some areas, particularly among inner-city children from racial and ethnic minority groups. Today, identifying areas with low childhood-vaccination coverage remains important, particularly if these areas are at risk for the introduction of disease. In 1995, the Centers for Disease Control and Prevention launched a congressionally mandated demonstrated project now called the Childhood Immunization Demonstration project of Community Health Networks. This mandate specified an assessment to determine whether a network of primary care providers affiliated with university teaching hospitals could assume a public health responsibility for raising immunization levels among preschoolers in medically underserved communities. Communities with federally designated health professional shortage areas were invited to submit proposals, and 4 were selected: Detroit, MI, New York, NY, San Diego, CA, and rural Colorado. OBJECTIVES: To measure immunization coverage among preschool children in the 4 selected medically underserved areas and determine predictors of coverage levels. DESIGN AND SETTING: Surveys in the 4 areas were based on stratified cluster probability sample designs in which clusters of dwelling units were selected and all households in selected clusters were screened for the presence of children aged 12 to 35 months. Immunization histories were obtained from parents and providers for these children. For each age-eligible child, the information collected on utilization of immunization health services included a listing of all clinics or offices ever used for the child's well-child care and/or for obtaining immunizations. Information was also collected on whether the child currently had health insurance (public and/or private) and whether the child had a medical home. A child was classified as having a medical home if the survey respondent reported a source of well care that was the same as the source of sick care and that this place was not an emergency department. PARTICIPANTS: Children 12 to 35 months of age in Detroit, New York, San Diego, and rural Colorado. OUTCOME MEASURE: Community-wide up-to-date (UTD) immunization coverage levels at 19 to 35 months of age, defined as receipt of 4 doses of diphtheria and tetanus toxoids and pertussis vaccine, 3 doses of poliovirus vaccine, 1 dose of measles, mumps, and rubella vaccine, 3 doses of Haemophilus influenzae type B vaccine, and 3 doses of hepatitis B vaccine (the 4:3:1:3:3 series). ANALYSIS: We examined the association between coverage level and independent variables and performed chi2 and t tests to determine whether differences observed within and between groups and sites were significant. RESULTS: The overall response rate for eligible children ranged from 79.4% to 88.1%. Coverage levels for most individual vaccines were >90% in all sites except Detroit. Coverage for the 4:3:1:3:3 series was significantly higher for children in New York (84%) and San Diego (86%) than for children in Detroit (66%) and rural Colorado (75%). Demographic risk factors related to UTD immunization status varied by site. Although differences in coverage levels by ethnicity varied by site, differences were not significant. In Colorado and New York, coverage was slightly lower among Hispanic than white children (71% vs 76% and 83% vs 91%, respectively). In San Diego, coverage was lower among whites, compared with Hispanics (76% vs 85%). Coverage was also lower for African American than white children only in New York (75% vs 91%). However, in San Diego and Colorado, children receiving their vaccinations from private providers had lower coverage levels than children receiving their vaccinations from other providers (78% vs 91% and 71% vs 57%, respectively). Ictively). In all 4 sites, children for whom respondents reported having an immunization card at the time of the interview were more likely to have higher series coverage levels than children for whom a parent-held card was not available. Also, children who were UTD at 3 months of age had significantly higher vaccination-series coverage levels than children who were not UTD at 3 months of age. In addition, the vaccination coverage was lower for children in Detroit whose parents reported problems accessing the health care system because lack of transportation (46%), compared with those who did not report such problems (65%); however, this difference did not reach significance (chi2 = 6.0). In Colorado, the small proportion of children in families without a phone had a lower vaccination coverage level (58%) than those in households with a phone (75%) (chi2 = 6.3). In all sites, children who were UTD at 3 months of age and had a parent-held vaccination card were more likely to be UTD at 19 to 35 months of age. CONCLUSIONS: Preschoolers in these medically underserved areas were not at uniform risk for underimmunization. Because they were designated as health professional shortage areas, the 4 sites in this study were expected to have low immunization-coverage rates. However, this was not the case. In fact, coverage in 3 of the 4 areas was quite high compared with US national figures (73%); only Detroit had a much lower UTD rate (66%). Efforts are needed to improve methods to identify areas with low immunization coverage so that resources can be directed to places where interventions are needed. Our results reveal that an area's need for childhood immunization interventions is not well predicted by a low number of providers per capita. Other criteria must be developed to predict areas or populations with low immunization coverage. Understanding more about the characteristics of children/provider pairs for children who are UTD at 3 months and more about the role of parental hand-held cards, along with finding strategies to improve immunization delivery by providers in Vaccines for Children Program facilities, suggest potentially productive avenues for increasing and sustaining high coverage levels.

Child, Preschool↗

PubMed2003

Gemcitabine added to doxorubicin, bleomycin, and vinblastine for the treatment of de novo Hodgkin disease: unacceptable acute pulmonary toxicity.

BACKGROUND: Gemcitabine is an effective treatment for recurrent Hodgkin disease (HD), with relatively minimal associated toxicity. The authors conducted a trial substituting this drug for dacarbazine in the standard regimen to form ABVG (doxorubicin, bleomycin, vinblastine, gemcitabine) for patients with newly diagnosed, high-risk HD. METHODS: Twelve patients (median age, 34 years) with advanced-stage de novo HD were enrolled. Standard doses of doxorubicin, bleomycin, and vinblastine were given for six cycles. Cohorts of three patients were enrolled and the dose of gemcitabine was escalated to identify the maximally tolerated dose in this combination. RESULTS: The maximally tolerated dose of gemcitabine was determined to be 800 mg/m(2) in this combination. Five patients developed clinically significant pulmonary toxicity. Three required hospitalization during the final two cycles of treatment. Pneumonitis could not be predicted with serial diffusion capacity for carbon monoxide (DECO) evaluations, and reversed after discontinuation of bleomycin in three patients and steroid therapy in two patients. All 12 patients are alive to date, and 4 patients have experienced disease progression. CONCLUSIONS: The bleomycin/gemcitabine combination should not be pursued for de novo HD due to significant pulmonary toxicity.

Adult↗

PubMed2003

Standards for adult immunization practices.

Since the Standards for Adult Immunization Practices were first published in 1990, healthcare researchers and providers have learned important lessons on how to better achieve and maintain high vaccination rates in adults. The success rate of childhood immunization far exceeds the success rate of adult immunization. Thus, information and practices that will produce higher success rates for adult vaccination are crucial, resulting in overall societal cost savings and substantial reductions in hospitalizations and deaths. The Standards, which were developed to encourage the best immunization practices, represent the collective efforts of more than 100 people from more than 60 organizations. The revised Standards are more comprehensive than the 1990 Standards and focus on the accessibility and availability of vaccines, proper assessment of patient vaccination status, opportunities for patient education, correct procedures for administering vaccines, implementation of strategies to improve vaccination rates, and partnerships with the community to reach target patient populations. The revised Standards are recommended for use by all healthcare professionals and all public and private sector organizations that provide immunizations for adults. All who are involved in adult immunization should strive to follow the Standards in order to create the same level of success achieved by childhood vaccination programs and to meet the Healthy People 2010 goals.

Adult↗

PubMed2002

African-American children are at risk of a measles outbreak in an inner-city community of Chicago, 2000.

BACKGROUND: Since the measles resurgence of 1989-1991, which affected predominantly inner-city preschoolers, national vaccination rates have risen to record-high levels, but rates among inner-city, preschool-aged, African-American children lag behind national rates. The threat of measles importations from abroad exists and may be particularly important in large U.S. cities. To stop epidemic transmission, measles vaccination coverage should be at least 80%. OBJECTIVE: To determine measles vaccination rates and predictors for having received a dose of measles-containing vaccine by age 19 to 35 months among children in an inner-city community of Chicago. METHODS: We used a cross-sectional survey with probability proportional to size cluster sampling. Immunization histories from parent-held records and providers were combined to establish a complete vaccination history. RESULTS: A total of 2545 households were contacted, and 170 included a resident child aged 12 to 35 months. Of these, 97% (N=165 children) agreed to participate. Immunization history from a parent or provider was not available for 20 children. Among children aged 19 to 35 months with available immunization histories, 74% received measles vaccine (n=100); of these, 84% received the vaccine as recommended at ages 12 to 15 months. However, when including children without immunization histories, measles coverage levels among children aged 19 to 35 months were 64% (n=114). Among children with records, predictors for receipt of measles vaccine by age 19 to 35 months were possessing a hand-held immunization card (odds ratio [OR]=16.8; 95% confidence interval [CI]=4.2-67.1); utilizing a public health department provider for a usual source of care (OR=8.9; 95% CI=1.6-47.2); and being up-to-date for vaccines at 3 months of age (OR=5.0; 95% CI=1.8-14.1). CONCLUSIONS: Optimistically assuming that children without immunization histories are as well immunized as children with immunization histories, the measles vaccination rate among Englewood's children aged 19 to 35 months is too low to maintain immunity (74%). Measles coverage levels lagged behind coverage reported in a national survey in Chicago (86%) and the nation as a whole (92%). Efforts to raise and sustain coverage should be undertaken.

Black or African American↗

PubMed2002

Dose-intensive therapy for extensive-stage small cell lung cancer and extrapulmonary small cell carcinoma: long-term outcome.

Treatment for extensive-stage small cell lung cancer (ES SCLC) or extrapulmonary small cell carcinoma (EPSC) is typically palliative. We set out to determine progression-free survival (PFS) and overall long-term survival of ES SCLC and EPSC patients, physiologically aged < or = 60 years, responding to first-line chemotherapy followed by high-dose combination alkylating agents with hematologic stem cell support. Patients in first-line chemotherapy response underwent stem cell collection (marrow, peripheral blood progenitor cells, or both) followed by high-dose therapy with 1 of 2 regimens: CBP (cyclophosphamide, cisplatin, and carmustine) or ICE (ifosfamide, carboplatin, and etoposide) with or without etanidazole. Involved-field radiotherapy was given to selected patients with oligometastatic disease distributed in sites allowing for reasonable radiation ports, and prophylactic cranial radiotherapy was given upon recovery to patients in complete response (CR) or near-CR. A total of 36 patients were treated. Of 29 patients with ES SCLC, 6 (21%) had achieved CR, 18 near-CR, and 5 partial response prior to high-dose therapy. Of 7 patients with EPSC, 3 (43%) had achieved CR, 3 had achieved near-CR, and 1 had progression of disease prior to high-dose therapy. Thirteen ES SCLC patients received high-dose CBP. Of the remaining 23 patients with SCLC or EPSC, 17 were treated with ICE and 6 with ICE plus etanidazole, a hypoxic cell sensitizer. Treatment-related mortality was 11% (4 of 36 patients). For all patients, the median event-free survival (EFS) was 5 months. The 2- and 5-year survivals after intensification were 12% (95% confidence interval [CI], 5%-31%) and 9% (95% CI, 3%-27%), respectively. Of the 30 patients in or near CR prior to high-dose therapy, 5 remain continuously progression-free (2 ES SCLC, 3 EPSC) for a median of 55 months (range, 1-96 months) after high-dose therapy. By multivariate analysis, factors associated with more favorable EFS were the use of a more aggressive induction regimen (ICE), and the EPSC histology. These factors were also associated with more favorable overall survival. Other factors associated with more favorable overall survival were the use of short induction therapy (< or = 4 cycles) and younger age (<50 years). Except for high-dose ICE with etanidazole, the use of high-dose systemic therapy in ES SCLC and EPSC was associated with low treatment-related morbidity and mortality over the past 5 years. Late complications were infrequent, and most patients returned to full-time work and activity, barring disease recurrence. Nonetheless, few patients with ES SCLC have progression-free long-term survival. We conclude that high-dose therapy is not indicated as an approach for ES SCLC, except as part of an investigative trial. Conversely, 3 of the 7 patients with EPSC remain relapse-free (range, 1-96 months), warranting further phase II evaluation of this approach in this population.

Adult↗

PubMedDate not supplied

The first oral rotavirus vaccine, 1998-1999: estimates of uptake from the National Immunization Survey.

OBJECTIVE: On August 31, 1998, the rhesus-human reassortant rotavirus vaccine (RRV-TV) was licensed for use in the U.S. During the next nine months, 15 cases of intussusception were reported among infants who received the vaccine. Case-control and cohort studies showed a significantly increased risk of developing intussusception within one week of receiving the vaccine; subsequent ecologic studies did not. In this study, the authors used data on RRV-TV vaccination rates from the National Immunization Survey (NIS) to estimate state and national RRV-TV uptake rates and factors associated with receiving RRV-TV. These estimates are a key component in evaluating published ecologic studies designed to investigate the relationship between receipt of the vaccine and intussusception. METHODS: The authors analyzed NIS data for children ages 19 to 35 months who were eligible to receive RRV-TV between September 1998 and July 1999. The authors estimated vaccine coverage and the number of doses administered by state, NIS sampling quarter, and birth cohort, and analyzed demographic and socioeconomic variables to evaluate their relationship with receiving RRV-TV. RESULTS: It was estimated that approximately 1 million doses of RRV-TV were administered to 504,585 (+/-61,854) children, 13.4% (+/-1.6%) of children who were eligible. The estimated number of doses administered and the vaccination coverage rate varied greatly from state to state. Children living in households with higher socioeconomic conditions were more likely to receive the vaccine. CONCLUSION: Ecologic studies had a limited ability to detect a significant increase in the population incidence rate of intussusception that could be attributed to RRV-TV because populations in these studies consisted primarily of children who did not receive the vaccine. The example from RRV-TV demonstrates some of the challenges of assessing the magnitude of the association between a vaccine and an uncommon or rare adverse event.

Administration, Oral↗