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PubMedDate not supplied

The Vaccine Safety Datalink project.

The Vaccine Safety Datalink (VSD) is a collaborative project between the National Immunization Program of the Centers for Disease Control and Prevention (CDC) and several large health maintenance organizations (HMOs) in the United States. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. hospital discharge, outpatient visits, emergency room visits, and deaths), and covariate data (e.g. birth certificates and census) are prospectively collected at multiple HMOs (initially four) and linked under joint protocol for analyses. Approximately 6 million people (2% of the US population) are members of HMOs participating in the VSD. The VSD has proven to be a valuable resource that has provided important information on a number of vaccine safety issues. The databases and infrastructure created for the VSD have also provided opportunities to address other immunization questions including vaccination coverage and cost-effectiveness. In a recent investigation of intussusception following rotavirus vaccination, the VSD methodology was expanded to include 10 managed care organizations. A cohort study was conducted that allowed estimation of incidence rates of intussusception and attributable risks associated with rotavirus vaccine.

Adverse Drug Reaction Reporting Systems↗
PubMed1993

Measles susceptibility and immunization: experiences in a forensic psychiatric hospital.

BACKGROUND: In response to a measles outbreak in the community, a measles immunization program was developed at our hospital for forensic psychiatric patients. METHODS: Measles antibody screening of all employees and patients by means of an enzyme-linked immunosorbent assay was followed by vaccination of susceptible persons. RESULTS: Serum samples from 813 employees and 868 patients during a 6-month period were analyzed. The susceptibility rate was 16.15% for employees and 13.60% for patients born in or after 1957. It was 4.67% for employees and 5.40% for patients born before 1957. The overall rate was 7.38% for employees and 8.53% for patients. A rate of 5% is known to be sufficient for transmission in institutions. Vaccine was given to 84.51% of susceptible patients. Vaccine failure occurred in 8.33%. Residual susceptibility rate was 1.84%. CONCLUSIONS: Cost analysis showed that screening of all individuals and immunization of susceptible persons was the most cost-effective method for measles control in our institutional setting.

Antibodies, Viral↗
PubMed2006

A new DTPw-HB/Hib combination vaccine for primary and booster vaccination of infants in Latin America.

OBJECTIVES: In 1998 the World Health Organization (WHO) recommended the inclusion of Haemophilus influenza type B (Hib) conjugate vaccines in infant immunization programs, whenever in accordance with national priorities. GlaxoSmithKline Biologicals has developed a new pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis B/Hib (DTPw-HB/Hib) vaccine containing 5 microg of polyribosylribitol phosphate (PRP), and we assessed the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with this new vaccine compared with a reference regimen consisting of the licensed DTPw-HB (Tritanrix) and Hib (Hiberix) vaccines given as simultaneous concomitant injections. METHODS: We performed a randomized, double-blind study from September 1998 to August 1999 to establish the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with the new pentavalent combined DTPw-HB/Hib vaccine given as a single injection, compared with the reference regimen. RESULTS: Both vaccination regimens elicited excellent immune responses, with all subjects in both groups achieving seroprotective anti-PRP antibody concentrations of > or = 0.15 microg/mL one month after primary vaccination. The combined DTPw-HB/Hib vaccine was non-inferior to the licensed vaccines in terms of seroprotection/seropositivity/vaccine response rates for all antigen components. Persistence of antibodies against all study vaccine antigens up to the time of booster vaccination was comparable between groups, and a marked increase of all antibody concentrations was observed after the booster dose. Both vaccine regimens were similar in terms of their overall reactogenicity profiles. CONCLUSIONS: Our results indicate that the new DTPw-HB/Hib pentavalent combination vaccine provides an efficient and reliable way of implementing WHO recommendations for controlling hepatitis B and Hib infections on a worldwide basis.

Child, Preschool↗
PubMed1982

Rubella screening and vaccination program for US Air Force trainees: an analysis of findings.

A preventive medicine program of rubella control for trainees at the Air Force Military Training Center, Lackland AFB, Texas, was begun in October 1977. Incoming trainees were screened for rubella susceptibility, and female trainees were additionally screened for pregnancy. During the period October 1977 to December 1978, an overall rubella susceptibility rate of 17.3 per cent was determined for 71,387 trainees entering basic training. Flights (50 persons each) to which these trainees are assigned varied widely in susceptibility from 0.0-47.7 per cent. Comparisons of susceptibility rates for trainees for for geographic areas and states indicated the highest overall percentage of susceptibles were from the Pacific geographic area with California showing the highest susceptibility (24.5 per cent). Race specific susceptibility rates were found to differ significantly between Whites and Blacks, 17.6 vs 14.8 per cent, respectively. The immunization program was effective as judged by a dampening of the incidence of clinical rubella at the basic training center and at other secondary training centers.

Adolescent↗
PubMed1990

The influenza vaccination demonstration project: an expanded policy goal.

In 1980, the Public Health Service established an objective of immunizing 60% of high-risk persons with influenza vaccine annually by the year 1990. As no more than 32% of high-risk persons currently receive influenza vaccine each year, the Health Care Financing Administration (HCFA) has undertaken an influenza vaccination demonstration project for Medicare enrollees. Federally purchased vaccine is being distributed to physicians, health departments, hospitals, nursing homes and health maintenance organizations (HMOs). If the project is cost-effective, Congress has authorized HCFA reimbursement for influenza vaccination. Changing reimbursement policy alone, however, is unlikely to substantially improve influenza vaccine delivery; HCFA reimbursement for pneumococcal immunization since 1981 has not increased the use of pneumococcal vaccine. In contrast, federal purchase and distribution of vaccines to state and local health departments has helped maintain the remarkable success of childhood immunization programs. In addition, in Canada, provincial health departments purchase more than 80% of all influenza vaccine distributed, and from 1980 through 1988, per capita vaccine distribution increased 140%. These experiences suggest the need for an expanded policy goal for the influenza vaccination demonstration project that includes federal purchase and distribution of influenza vaccine. This approach, together with a change in reimbursement policy, offers greater promise for achieving our nation's objective for influenza vaccination.

Aged↗
PubMed2026

Dengue and chikungunya vaccines past, present and future: implications for travelers.

PURPOSE OF REVIEW: Novel vaccines for dengue and chikungunya viruses offer new prevention options against two globally important arboviral diseases. This review summarizes recent developments in vaccine licensure, implementation, real-world experience and research priorities, with emphasis on implications for both endemic populations and travelers. RECENT FINDINGS: Of the three live-attenuated dengue vaccines licensed to date, TAK-003 is authorized in >40 countries and Butantan-DV in Brazil, while manufacturing of CYD-TDV is discontinued. Long-term and postmarketing data continue to refine understanding of serotype-specific protection, waning immunity, and rare adverse events.For chikungunya, two single-dose vaccines are licensed-a live-attenuated vaccine (VLA1553) and virus-like particle vaccine (PXVX0317). Uptake is guided by emerging safety and effectiveness data, with each platform offering potential advantages in different settings.Further data on long-term protection, safety, effectiveness, use in vulnerable populations and integration into outbreak management and immunization systems is anticipated. SUMMARY: Dengue and chikungunya vaccines are increasingly being used in immunization programs and pretravel consultations. Further real-world data are needed-particularly for seronegative dengue vaccine recipients and older, immunocompromised or medically at-risk adults. Research priorities include developing single-dose, nonlive dengue vaccines suitable for high-risk groups, understanding long-term chikungunya vaccine performance, and exploring broader flaviviral or pan-arboviral platforms.

Humans↗
PubMed1985

Use of influenza vaccine in nursing homes.

The organization and outcome of influenza immunization programs were studied in 67 randomly or systematically selected nursing homes (8354 residents) in six states during the autumn of 1982 and/or 1983. In each home, influenza vaccine was usually offered to all residents on a voluntary basis, independent of their age, level of required nursing care, or underlying medical conditions. However, the proportion of residents who were vaccinated ranged from 8 to 98% (mean, 62% overall), with significantly lower rates in homes that also required consent from relatives (usually by return mail) than in homes that did not (P less than .00001; median, 57 versus 90%, respectively). These observations suggest that distribution of educational materials about the risks and benefits of influenza vaccine and systematic follow-up of relatives who fail to return the consent form may be useful strategies to further increase the number of nursing home residents who are immunized.

Aged↗
PubMed2000

[Family practitioners in the primary health care of preschool-age children--a report on well-child care in the practice of 2 family medicine physicians].

Primary health care of preschool children is organized in the Republic of Croatia by pediatricians, general practitioners and family/general practice specialist. The aim of this study is to evaluate the care for preschool children in the well baby clinics led by general/family specialist. Vaccination and visits data were collected from the medical records of 148 children born from January 1st 1992 till December 31st 1997, registered in two family practice offices in the well baby clinics at the Dugave-Travno Health Station of the "Novi Zagreb" Health Center. Comparison was made between data on compulsory immunization minimum in the Republic of Croatia and data from the Croatian National Institute of Public Health on vaccination of infants and preschool children in the Republic of Croatia in 1997. Diphtheria, tetanus and poliomyelitis vaccination was 100%, pertussis vaccination was 97.2%, measles and parotitis vaccination was 92.2% and rubella vaccination was 91.5%. Diphtheria and tetanus revaccination of children in the second year of life was 97.6%, pertussis revaccination was 94.4% and poliomyelitis revaccination was 96.8%. Comparison of those results proves the efficacy of compulsory immunization program of preschool children in family/general specialists' offices. The accessibility of general/family practice, appropriate education of general/family specialists during the specialization in family medicine for primary care of preschool children as well as for other family members, the ability of family physician to offer integrated continuous care and good cooperation of the family physician and the public nurse are the factors that enable appropriate primary care for preschool children in general practice/family medicine.

Child Health Services↗
PubMedDate not supplied

[Cost of tetanus toxoid injection using a jet-injector (Imule) in collective immunization in Senegal: comparison with injection using a syringe and resterilizable needle].

Needle-less jet injectors were developed by the US army after World War II. Their principal use, however, has been in the administration of lyophilized vaccines from multidose vials to at-risk populations in developing countries. In 1983, a hepatitis B epidemic occurred among customers of a beauty clinic in California (USA) following the use of jet-injectors, demonstrating a clear risk of cross-contamination associated with this technique. As a result, the WHO and Unicef stopped recommending jet-injectors for collective immunizations in developing countries. To eliminate the risk of contamination, Pasteur Mérieux Sérums et Vaccins (now Aventis Pasteur) developed, in 1990, jet-injectors for use with single-use vaccine cartridges. These injectors were tested for tetanus toxoid, DTP, influenza, hepatitis A and typhoid Vi vaccination. The immunogenic reaction was as strong and the injection as well tolerated as for injections using a standard needle and syringe. The additional cost of the Imule technique was evaluated in a district-wide (127,000 inhabitants) tetanus toxoid immunization program at Velingara, Senegal in 1993. The total cost was estimated to be 1.51 FF (76 F CSA, 0.32 US dollars) for one dose of tetanus vaccine given by needle and syringe and 2.41 FF (121 F CSA, 0.56 US dollars) for one dose given by Imule. Thus, the additional cost of injection by ImuleTM was 0.90 FF (45 F CSA, 0.21 US dollars). The cost of cross infection in sub-Saharan Africa has been estimated to be 2.37 FF (118 F CSA, 0.55 US dollars) per injection if injection practices are not supervised. Therefore, the Imule technique may be considered to be cost-effective. However, the technique is still not completely reliable, as shown by the total breakdown of four jet injectors during this vaccination session. Lyophilized vaccines have also not been tested in the field. Vaccinators prefer Imule, training is easy and immunization can be carried out on a day-to-day basis with no vaccine wastage. Imule is not yet in mass production, which would reduce costs. In the face of the ever-increasing risk of cross-contamination during vaccination sessions in sub-Saharan Africa, the Imule technique deserves considerable attention.

Cost-Benefit Analysis↗
PubMedDate not supplied

Eradication of indigenous poliomyelitis in Canada: impact of immunization strategies.

During the period 1950-1954, surveillance for paralytic poliomyelitis in Canada revealed an average of 1,914 cases (13.2 cases per 100,000) annually. The licensing and widespread use of inactivated poliovirus vaccine (IPV) in 1955 coincided with a marked decline in disease rates. Due to incomplete vaccine coverage of the population, a resurgence began in 1958 and peaked in 1959, despite an observed vaccine efficacy of 96% for 3 doses of IPV. The introduction and widespread use of oral poliovirus vaccine (OPV) started in 1960 and coincided with a decline in disease rates. Virtual elimination of the natural disease was achieved in the 1970s in all provinces regardless of the specific immunization program chosen (IPV or OPV alone or combined). From 1965 to 1988, 51 cases of paralytic poliomyelitis were reported in Canada. Thirty-five of these cases, all but one occurring before 1980, were attributed to wild virus infection, (14 caused by imported virus and 21 assumed to be endemic). Sixteen cases were OPV-associated: 4 in vaccine recipients and 12 in contacts of OPV recipients. Vaccine-associated paralysis in recipients and contacts occurred at the rate of one case per 9.5 million and 3.2 million vaccine doses distributed, respectively. The risk of paralysis attributable to OPV therefore is small compared to the overall benefit of the vaccine. Both IPV and OPV appear equally effective, and theoretically, a combination of the two (IPV followed by OPV) provides the best risk benefit ratio. Occasional exposure of the Canadian population to imported wild virus requires that high levels of population immunity be maintained.

Adolescent↗
PubMed1980

Influenza immunization of children with neoplastic diseases.

During the National Influenza Immunization Program in 1976, 147 children with neoplastic diseases received Wyeth split-product bivalent influenza vaccine: A/New Jersey/8/76 (HSW1N1), A/Victoria/3/75 (H3N2). Thirteen normal siblings served as controls. Seventy-one patients received two doses of the vaccine four weeks apart. After the second injection of A/NJ/8/76, there was a difference between the response of the patients on chemotherapy and those off therapy greater than or equal to 30 days--38% vs. 76%, P less than 0.01 for four-fold rise and 26% vs. 57%, P less than 0.05 for the attainment of protective (greater than or equal to 32) hemagglutination inhibition (HI) titers. These differences were observed in both leukemia-lymphoma and solid tumor patients. There was a difference in HI titers to A/Vic/75 between patients on and off chemotherapy after a single injection, 34% vs. 71%, P less than 0.001 for a four-fold rise. After the second immunization, only 52% on, and 86% off therapy (P less than 0.05) had a four-fold rise in titers. Thirty-two percent of the patients on treatment who achieved "protective" titers did so only after the second immunization. Immunoglobulin levels and neutropenia did not correlate with the inability to obtain a four-fold rise in titers. Our findings suggest that patients on chemotherapy cannot be effectively vaccinated by a new antigen, and that single yearly boosters may be insufficient for recall of old antigens. Patients off chemotherapy greater than or equal to 30 days respond as normal controls.

Antibodies, Viral↗
PubMed1984

Swine flu vaccine and multiple sclerosis.

Using age-specific rates for multiple sclerosis (MS) based on a national survey, the number of "naturally occurring" new cases of MS among the 45 million swine flu vaccine recipients in the United States is estimated as 1,624 during the year after vaccination, or 31 cases per week. Information from available reports and publications indicates no excess over the expected frequencies. Analyses of admissions for MS before, during, and after the immunization program showed no increase to the US Army hospitals or to the Mayo Clinic. Three independent controlled clinical investigations performed on patients with MS showed no increase in the frequency of exacerbations among those receiving swine flu vaccine as compared with those receiving placebo. Epidemiologic features of MS do not implicate killed virus vaccine as an etiologic factor in onset or exacerbations of the disease. There is no indication from these analyses of any association or cause-and-effect relationship between swine flu vaccine and MS.

Adult↗
PubMed1988

Maternal rubella and the congenital rubella syndrome.

The major goal of rubella immunization is the prevention of the congenital rubella syndrome. As many as 20 per cent of women in the reproductive age group in the United States continue to be susceptible to rubella despite the immunization programs currently in place. Intensified efforts are therefore needed to identify persons at risk for infection and to vaccinate them. Women who develop a rubella-like illness during pregnancy should have the diagnosis confirmed serologically because a diagnosis based on clinical criteria alone is unreliable and because of the serious implications of gestational rubella infection. The rubella virus can infect the fetus at any stage of pregnancy, but defects are rarely noted when this occurs after the 16th week of gestation. The most common abnormalities in the congenital rubella syndrome are hearing loss, mental retardation, cardiac malformations, and eye defects. Diabetes mellitus, thyroid disease, glaucoma, and other delayed manifestations of congenital rubella syndrome are common, thereby necessitating long-term followup of these patients. The detection of rubella-specific IgM antibodies in fetal blood is helpful in establishing the diagnosis prenatally and can aid in the management of pregnancies complicated by this infection. Susceptible women identified through screening during pregnancy should be immunized in the immediate postpartum or postabortion period. Although the live, attenuated rubella vaccine is contraindicated during pregnancy, pregnant women who are inadvertently immunized are not candidates for pregnancy termination because no defects consistent with congenital rubella have been reported to date in the offspring of other similarly vaccinated women.

Female↗
PubMedDate not supplied

Microencapsulated vaccines to provide prolonged immunity with a single administration.

Vaccines that provide lasting immunity with a single administration of the antigen can reduce the cost of routine immunization programs while increasing their efficacy by lessening the need for patient compliance. The authors have been developing methods for using biodegradable polymer microspheres to encapsulate vaccines. These microcapsules are designed to provide timed release of the antigen on a schedule that mimics conventional booster shots. The microspheres are made from poly-DL-lactide-co-glycolide. The rate of biodegradation of this polymer is controllable by varying the molar ratio of the monomers. High performance liquid chromatography was used to measure release kinetics in vitro, and a process was developed for the encapsulation of water soluble protein antigens. This process then was used to prepare a microencapsulated vaccine for type A botulism made using a recombinant C fragment antigen. A series of 27 adult C57BL/6J mice were used to study the efficacy of this vaccine. Six mice injected with saline filled microspheres served as a control group. Plasma samples were taken weekly to measure antibody levels using enzyme linked immunosorbent assay. At 14 weeks, 21 immunized mice and six control subjects were used for an aerosol challenge test with botulinum toxin. All control subjects died within 72 hrs. Fifteen (71%) of the immunized mice survived.

Animals↗
PubMed2002

Pharyngeal colonization with Haemophilus influenzae type b among healthy Turkish infants and children.

BACKGROUND: An absence of Haemophilus influenzae type b (Hib) disease surveillance and epidemiological data on the pharyngeal carriage of Turkish children causes delay in the introduction of conjugated Hib vaccination into proposed national vaccination programs. METHODS: Oropharyngeal cultures were obtained from 1404 healthy infants and children. Six healthy child clinic (HCC), 11 day-care centers (DCC) and seven elementary schools (ES) were randomly selected in seven different counties at the Anatolian side of Istanbul between January and April 2000. RESULTS: Haemophilus influenzae was isolated from 315 (22.8%) of all participants and 98 (31%) isolates were serotype b. The carriage rate for Hib was higher in children at DCC (43 out of 448, 9.6%) and ES (46 out of 504, 9.1%) compared to infants 0-24 months of age (nine out of 430, 2.1%) presented to HCC. All Hib isolates were susceptible to azithromycin, chloramphenicol and cefotaxime. Beta-lactamase production was detected in only one isolate. Trimethoprim-sulfamethoxazole resistance was found in 8.5% of Hib isolates. Multivariate analysis showed that DCC and ES attendance were independent predictors of Hib carriage. CONCLUSION: A significant proportion of healthy Turkish children was shown to be colonized with Hib. The burden of invasive Hib infections should be determined in order to evaluate the Hib conjugated vaccine as a part of a routine immunization program in Turkey.

Child↗
PubMedDate not supplied

The national survey of children with special health care needs.

CONTEXT: The federal and state-level Children with Special Health Care Needs (CSHCN) programs are vested with the responsibility for planning and developing systems of care for children with special health care needs. To support achievement of this goal, the federal Maternal and Child Health Bureau (MCHB), in partnership with the National Center for Health Statistics (NCHS), has developed a new survey that will provide uniform national and state data on the prevalence and impact of special health care needs among children. PURPOSE: The National Survey of CSHCN is designed to produce reliable state- and national-level estimates of the prevalence of special health care needs using MCHB's definition of CSHCN. It will also provide baseline estimates for federal and state Title V Maternal and Child Health performance measures, for Healthy People 2010 national prevention objectives, and for each state's Title V needs assessment. In addition, it will provide a resource for researchers, advocacy groups, and other interested parties. It is anticipated that this survey will be repeated periodically, thereby making trend analysis possible. METHODS: This survey is being conducted using the State and Local Area Integrated Telephone Survey mechanism, which shares the random-digit-dial sampling frame of the National Immunization Survey (sponsored by the National Immunization Program and NCHS). Using the CSHCN Screener, developed under the auspices of the Foundation for Accountability, 750 children with special health care needs will be identified and selected from each state and from the District of Columbia. Parents or guardians of these children then complete a comprehensive battery of questions on demographics, health and functional status, health insurance coverage, adequacy of health insurance coverage, public program participation, access to care, utilization of health care services, care coordination, satisfaction with care, and the impact of the special need on the family. Data collection began in October 2000 and will continue through March 2002. Summary reports and electronic data files will be available to the public within 6 to 12 months following completion of data collection. CONCLUSIONS: The National Survey of CSHCN will offer a unique data source for individuals and organizations interested in understanding and improving service delivery for CSHCN. It is an accomplishment that reflects the contributions of state and federal Title V programs, family organizations, provider organizations, health services researchers, and the broader maternal and child health community.

Adolescent↗
PubMed2003

Seroconversion after measles vaccination at nine and fifteen months of age.

BACKGROUND: Despite high vaccination coverage, single dose measles immunization programs have been unsuccessful in eliminating the disease. Because seroconversion rates are lower in infants vaccinated before 12 months of age, a second dose of measles vaccine is recommended at 15 months. The aim of this study was to determine the seroconversion rates in children after the first and second doses of measles vaccinations at 9 and 15 months of age. METHODS: Study population comprised 116 infants attending the Well Baby Clinic of Istanbul University, Faculty of Medicine. Serum specimens were obtained from children before and 1 month after the first measles (Rouvax, Schwarz strain 1000 TCID(50)) vaccine given at 9 months. A second dose was given to 72 children at 15 months of age as measles-mumps-rubella (Trimovax, Schwarz measles strain, 1000 TCID(50); Urabe Am 9 mumps strain, 5000 TCID(50); Wister RA 27/3 rubella strain, 1000 TCID(50)). Third blood samples were collected 20 months after the second vaccine. RESULTS: Passive antibody positivity rate was 5.2% at the age of 9 months. Seroconversion rate was 77.6% after the first dose and 81.9% after the second dose of measles vaccine. Of 15 children who were seronegative, 13 (86.7%) became seropositive after the immunization at 15 months. Eleven children (19.2%) seroconverted from positive to negative after the second vaccine. CONCLUSION: The two dose schedule seems to increase the seropositivity rate. Our findings also indicate that increasing vaccination coverage and revaccination at 6 years of age are important even with the early two dose schedule.

Antibodies, Viral↗