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Haemophilus influenzae type b vaccination and risk of childhood leukemia in a vaccine trial in finland
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ABSTRACTS (ACE)
AEP Vol. 10, No. 7 October 2000: 449–483
HAEMOPHILUS INFLUENZAE TYPE B VACCINATION AND RISK OF CHILDHOOD LEUKEMIA IN A VACCINE TRIAL IN FINLAND F Groves, A Auvinen, T Hakulinen, Department of Biometry and Epidemiology, Medical University of South Carolina, Charleston, SC PURPOSE: To compare the incidence of childhood leukemia among children who received multiple early vaccine doses versus a single late dose in the context of a clinical trial in Finland during 1986 and 1987. METHODS: The trial was offered to the parents of all 114,000 children born in Finland between October 1, 1985 and August 31, 1987; 98% of the eligible children were enrolled. The vaccine consisted of heat-sized capsular polysaccharide of Haemophilus influenzae type b (Hib) coupled to diptheria toxoid (PRP-D). Children with odd birth dates received four doses of the vaccine at the ages of 3, 4, 6, and 14 months; children with even birth dates received only one dose, at the age of 24 months. The numbers of boys and girls with even and odd birth dates during the window of eligibility who remained alive during the follow-up period were obtained from the Finnish Population Registry. Numbers of leukemia cases diagnosed through 1996 among children with even and odd birth dates during the window of eligibility were obtained from the Finnish Cancer Registry. Poisson regression analysis of leukaemia incidence rates was conducted using the number of cases as the outcome variable and the natural logarithm of number of children at risk as an offset term. For comparison of the early and late vaccination groups, a binary variable based on odd or even date of birth was used. RESULTS: Among the 114,000 subjects, a total of 77 cases of childhood leukaemia were diagnosed: 33 in the early-vaccination group and 44 in the late-vaccination group. The incidence of childhood leukaemia was lower in the early-vaccination group (relative risk 0.72, 95% confidence interval 0.46–1.13) than in the late-vaccination group, but the difference did not reach statistical significance. CONCLUSIONS: Our results suggest that early vaccination against Hib may reduce the incidence of childhood leukaemia, but confirmatory studies are needed. PII S1047-2797(00)00110-1
ANTIRETROVIRAL PRESCRIBING PATTERNS IN THE TEXAS PRISON SYSTEM JG Baillargeon, MJ Borucki, S Zepeda, HB Jenson, CT Leach, Department of Pediatrics, University of Texas Health Science Center at San Antonio, San Antonio, TX PURPOSE: Although prison inmates are reported to exhibit substantially elevated rates of HIV infection, little is known about HIV treatment patterns, particularly pharmacotherapy, in correctional institutions. The purpose of the present study, therefore, was to describe antiretroviral prescribing patterns in one of the nation’s largest prison populations. METHODS: The study population consisted of all known (n ⫽ 2,360) HIV-infected inmates incarcerated in the Texas prison
system in 1998. Information on medical conditions, sociodemographic factors, and pharmacotherapy was obtained from an institution-wide medical information system. Inmates who received more than one type of pharmacotherapy in 1998 were included in the appropriate number of categories. RESULTS: In 1998, 66.8 percent (95% CI ⫽ 64.0–69.4) of all HIV-infected inmates with CD4 counts below 500 were treated with highly active antiretroviral therapy (HAART); and 31.1 percent (95% CI ⫽ 29.3–33.0) were given no antiretroviral therapy. Logistic regression results showed that HAART treatment decreased monotonically as a function of patient CD4 count category. CONCLUSIONS: A substantial proportion of HIV-infected TDCJ inmates were placed on therapies that were not consistent with the generally recommended DHHS guidelines for their disease stage. It will be important to for future investigations to assess whether such patterns continue to exist among prison populations, and to assess the determinants of these patterns.
PII S1047-2797(00)00128-9
THE CHANGING EPIDEMIC OF PEDIATRIC HIV INFECTION IN ROMANIA CA Kozinetz, R Matusa, A Cazazu, Department of Pediatrics, Baylor College of Medicine, Houston, TX, and Speranta Association, Constanta, Romania PURPOSE: By the late 1980s, over 100,000 infants and children were living in public institutions in Romania. It was not uncommon for children in these facilities to receive one or more ‘micro-transfusions’ of blood, unscreened for HIV, as therapy for anemia or malnutrition. To assess the impact of pediatric HIV infection in Romania, the European country with the most pediatric cases, cross-sectional and cohort studies were implemented in Constanta (the epi-center of pediatric HIV in Romania) in April 1999. METHODS: Demographic, clinical and social data are collected once for all cross-sectional subjects. Similar data are collected every 11–13 months for subjects in the cohort. The cross-sectional study population was defined as all living HIV-infected infants and children, 0-18 years, known to the investigators from April to September 1999. The cohort consists of subjects diagnosed with HIV between 1995 and 1999. RESULTS: Enrolled are 791 subjects, of which 357 are in the cohort study. The majority (83%) are Romanian, vs Gypsy or Turkish/Hun and their mean age is 11 years (SD ⫽ 1.3). Biologic parents are the primary caretakers of 77% and 86% attend school. Mode of transmission was perinatal for 8%; blood transfusion/ parental therapy modes account for 89% of the transmission and the presumed timing was between 1–12 months of age. Mean age at HIV confirmation was 5 years (SD ⫽ 3.2). AIDS has been diagnosed in 40% and 52% are receiving antiretroviral therapy. CONCLUSIONS: The Romanian pediatric HIV epidemic differs vastly from that in the US. Fewer children are with their biologic parent(s) and attending school. Early diagnosis of infection is rare, as therapy did not become available until the
ABSTRACTS (ACE)
AEP Vol. 10, No. 7 October 2000: 449–483
HAEMOPHILUS INFLUENZAE TYPE B VACCINATION AND RISK OF CHILDHOOD LEUKEMIA IN A VACCINE TRIAL IN FINLAND F Groves, A Auvinen, T Hakulinen, Department of Biometry and Epidemiology, Medical University of South Carolina, Charleston, SC PURPOSE: To compare the incidence of childhood leukemia among children who received multiple early vaccine doses versus a single late dose in the context of a clinical trial in Finland during 1986 and 1987. METHODS: The trial was offered to the parents of all 114,000 children born in Finland between October 1, 1985 and August 31, 1987; 98% of the eligible children were enrolled. The vaccine consisted of heat-sized capsular polysaccharide of Haemophilus influenzae type b (Hib) coupled to diptheria toxoid (PRP-D). Children with odd birth dates received four doses of the vaccine at the ages of 3, 4, 6, and 14 months; children with even birth dates received only one dose, at the age of 24 months. The numbers of boys and girls with even and odd birth dates during the window of eligibility who remained alive during the follow-up period were obtained from the Finnish Population Registry. Numbers of leukemia cases diagnosed through 1996 among children with even and odd birth dates during the window of eligibility were obtained from the Finnish Cancer Registry. Poisson regression analysis of leukaemia incidence rates was conducted using the number of cases as the outcome variable and the natural logarithm of number of children at risk as an offset term. For comparison of the early and late vaccination groups, a binary variable based on odd or even date of birth was used. RESULTS: Among the 114,000 subjects, a total of 77 cases of childhood leukaemia were diagnosed: 33 in the early-vaccination group and 44 in the late-vaccination group. The incidence of childhood leukaemia was lower in the early-vaccination group (relative risk 0.72, 95% confidence interval 0.46–1.13) than in the late-vaccination group, but the difference did not reach statistical significance. CONCLUSIONS: Our results suggest that early vaccination against Hib may reduce the incidence of childhood leukaemia, but confirmatory studies are needed. PII S1047-2797(00)00110-1
ANTIRETROVIRAL PRESCRIBING PATTERNS IN THE TEXAS PRISON SYSTEM JG Baillargeon, MJ Borucki, S Zepeda, HB Jenson, CT Leach, Department of Pediatrics, University of Texas Health Science Center at San Antonio, San Antonio, TX PURPOSE: Although prison inmates are reported to exhibit substantially elevated rates of HIV infection, little is known about HIV treatment patterns, particularly pharmacotherapy, in correctional institutions. The purpose of the present study, therefore, was to describe antiretroviral prescribing patterns in one of the nation’s largest prison populations. METHODS: The study population consisted of all known (n ⫽ 2,360) HIV-infected inmates incarcerated in the Texas prison
system in 1998. Information on medical conditions, sociodemographic factors, and pharmacotherapy was obtained from an institution-wide medical information system. Inmates who received more than one type of pharmacotherapy in 1998 were included in the appropriate number of categories. RESULTS: In 1998, 66.8 percent (95% CI ⫽ 64.0–69.4) of all HIV-infected inmates with CD4 counts below 500 were treated with highly active antiretroviral therapy (HAART); and 31.1 percent (95% CI ⫽ 29.3–33.0) were given no antiretroviral therapy. Logistic regression results showed that HAART treatment decreased monotonically as a function of patient CD4 count category. CONCLUSIONS: A substantial proportion of HIV-infected TDCJ inmates were placed on therapies that were not consistent with the generally recommended DHHS guidelines for their disease stage. It will be important to for future investigations to assess whether such patterns continue to exist among prison populations, and to assess the determinants of these patterns.
PII S1047-2797(00)00128-9
THE CHANGING EPIDEMIC OF PEDIATRIC HIV INFECTION IN ROMANIA CA Kozinetz, R Matusa, A Cazazu, Department of Pediatrics, Baylor College of Medicine, Houston, TX, and Speranta Association, Constanta, Romania PURPOSE: By the late 1980s, over 100,000 infants and children were living in public institutions in Romania. It was not uncommon for children in these facilities to receive one or more ‘micro-transfusions’ of blood, unscreened for HIV, as therapy for anemia or malnutrition. To assess the impact of pediatric HIV infection in Romania, the European country with the most pediatric cases, cross-sectional and cohort studies were implemented in Constanta (the epi-center of pediatric HIV in Romania) in April 1999. METHODS: Demographic, clinical and social data are collected once for all cross-sectional subjects. Similar data are collected every 11–13 months for subjects in the cohort. The cross-sectional study population was defined as all living HIV-infected infants and children, 0-18 years, known to the investigators from April to September 1999. The cohort consists of subjects diagnosed with HIV between 1995 and 1999. RESULTS: Enrolled are 791 subjects, of which 357 are in the cohort study. The majority (83%) are Romanian, vs Gypsy or Turkish/Hun and their mean age is 11 years (SD ⫽ 1.3). Biologic parents are the primary caretakers of 77% and 86% attend school. Mode of transmission was perinatal for 8%; blood transfusion/ parental therapy modes account for 89% of the transmission and the presumed timing was between 1–12 months of age. Mean age at HIV confirmation was 5 years (SD ⫽ 3.2). AIDS has been diagnosed in 40% and 52% are receiving antiretroviral therapy. CONCLUSIONS: The Romanian pediatric HIV epidemic differs vastly from that in the US. Fewer children are with their biologic parent(s) and attending school. Early diagnosis of infection is rare, as therapy did not become available until the