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Biomedical subjects

P A Patriarca

Publications and source records attributed to P A Patriarca.

At least 19 recordsLinked to original sources

Syncope after immunization.

OBJECTIVE: To describe the individual characteristics, clinical features, and morbidity associated with syncope following immunization. DESIGN: Large case series. SETTING: United States, 1990 through 1995. SUBJECTS: Reports to the national Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system. An additional 3 reports of head injury (documented by medical records) were obtained through the National Vaccine Injury Compensation Program. MAIN OUTCOME MEASURES: Syncope, syncope and hospitalization, or syncope and head injury within 12 hours of vaccination. RESULTS: A total of 697 cases of syncope after vaccination was reported. Age younger than 20 years was reported for 77.4%; 57.5% were female. Hospitalization was reported in 9.6%. Of the 571 syncope events with known time, 511 occurred 1 hour or less after vaccination. Of these, 323 (63.2%) occurred 5 minutes or less, 454 (88.8%) occurred 15 minutes or less, and 500 (97.8%) occurred 30 minutes or less after vaccination. Tonic or clonic movements, which have been associated with the anoxia of vasovagal syncope, were reported in 30.4% of syncopal episodes occurring 15 minutes or less after and in 12.8% of those occurring 15 minutes or longer after vaccination (P < .001). Six patients suffered skull fracture, cerebral bleeding, or cerebral contusion after falls; 3 of these patients required neurosurgery. Falls occurred 15 minutes or less after vaccination, in or near the clinic or office. Ages ranged from 12 to 28 years; 5 of 6 were male. Follow-up revealed substantial residual impairment in 2 patients. CONCLUSIONS: Prevention of injury from syncope after vaccination and of syncope itself may be possible in many cases. Vaccinators should be aware that patients exhibiting presyncopal signs and symptoms around the time of immunization need to be evaluated carefully and may need to be assisted to sit or lie down after immunization until free of symptoms.

Accidental Falls

Influenza pandemic preparedness plan for the United States.

In preparation for the next influenza pandemic, a comprehensive and action-oriented plan is presently under development that focuses on six major areas: (1) improvements in ongoing virologic and disease-based surveillance systems; (2) vaccination of high-priority target groups, and, given sufficient vaccine supplies, the entire US population; (3) liability programs for vaccine manufacturers and health care providers; (4) research to improve detection of new variants and to accelerate the availability of existing and novel vaccines and antiviral agents; (5) integrated, multicomponent communication systems for rapid information dissemination and exchange; and (6) emergency preparedness plans to provide for adequate medical care and maintenance of essential community services. The sudden and unpredictable emergence of pandemic influenza and its potential for causing severe health and social consequences dictate the need for close collaboration among a wide variety of organizations in both the public and private sectors.

Humans

Outbreaks of paralytic poliomyelitis, 1976-1995.

During 1976-1995, 48 outbreaks of paralytic poliomyelitis with a cumulative total of approximately 17,000 cases were reported worldwide. Outbreaks occurred on most continents, affected from 0.1 to 52 persons per 100,000 total population (median, 4.4), lasted 2-25 months (median, 7), typically involved unvaccinated or inadequately vaccinated subgroups within highly immunized communities, and were primarily caused by poliovirus type 1 (74%). Cases in developing countries occurred predominantly among children <2 years of age, while those in industrialized countries tended to occur in older persons who had escaped natural infection earlier in life and who had not been vaccinated or had received poliovirus vaccine of inadequate potency. Partial genomic sequencing studies indicated that at least 15 outbreaks resulted from importation of wild polioviruses, primarily from the Indian subcontinent. These findings illustrate the potential for wide dissemination of wild poliovirus infection and underscore the critical need for maintaining high levels of immunity in all countries and for more aggressive vaccination efforts in areas in which polio is endemic.

Child, Preschool

Increased immunogenicity of oral poliovirus vaccine administered in mass vaccination campaigns compared with the routine vaccination program in Jordan.

To compare the immunogenicity of routine versus mass campaign doses of oral poliovirus vaccine (OPV), serum neutralizing antibodies were measured in 254 children before and after two mass vaccination campaigns in Jordan. Precampaign seroprevalences to poliovirus types 1, 2, and 3 in children who had received three, four, or five routine doses of OPV were compared with postcampaign seroprevalences in children who had received one, two, or three routine doses plus two mass campaign doses. Seroprevalences were consistently higher in subgroups that received two doses through mass campaigns than in subgroups that received all doses through the routine program, especially for poliovirus type 3. Geometric mean titers were also consistently higher for mass campaign subgroups, particularly for poliovirus type 3. The findings suggest that adding further doses of OPV to the routine schedule is unlikely to have as great an impact on the immune state of children as administering the same number of doses during mass campaigns.

Child, Preschool

Humoral and mucosal immunity in infants induced by three sequential inactivated poliovirus vaccine-live attenuated oral poliovirus vaccine immunization schedules. Baltimore Area Polio Vaccine Study Group.

The relative immunity induced by sequential administration of inactivated poliovirus vaccine (IPV) produced in human diploid cells and live attenuated oral poliovirus vaccine (OPV) was evaluated by randomization of 510 infants to receive IPV and OPV sequentially according to one of three experimental schedules, IPV only, or OPV only. The antibody response to two IPV doses was lower than expected. However, for each of the IPV-OPV sequential schedules, the first OPV dose significantly enhanced seroconversion rates and geometric mean microneutralization antibody titers. Three months after the final dose, 96%-99%, 99%-100%, and 81%-100% of infants had antibodies to poliovirus types 1, 2, and 3, respectively, and subjects with two or more prior OPV doses were significantly less likely than those with none or one prior OPV dose to excrete virus in feces after an OPV challenge. Sequential IPV-OPV immunization is now recommended for routine use in the United States. The optimal schedule consists of two IPV doses followed by two OPV doses.

Antibodies, Viral

The effect of diarrhea on oral poliovirus vaccine failure in Brazil.

The effect of diarrhea on oral poliovirus vaccine (OPV) failure was evaluated using data from Brazil, where 728 infants were immunized at birth (OPV1) and approximately 6 (OPV2), 10 (OPV3), and 14 (OPV4) weeks. Recent diarrhea history was significantly associated with increased vaccine failure only after OPV2 for poliovirus types 2 and 3. In multivariate models, controlling for breast feeding, season of vaccine administration (type 3 only), maternal antibody (type 3 only), and immunization campaign exposure (type 3 only) strengthened this effect. Diarrhea at OPV receipt was associated with vaccine failure to poliovirus types 1 and 3 only after OPV2. These data support the current recommendation that children with diarrhea receive OPV and be reimmunized once their illness resolves. Expanding this recommendation to include children with a recent diarrhea history should be considered. While the effect of diarrhea on vaccine failure may be limited to OPV2, programmatic realities may preclude dose-specific recommendations.

Brazil

Outbreak of paralytic poliomyelitis in a highly immunized population in Jordan.

Between November 1991 and March 1992, 37 cases of paralytic poliomyelitis occurred in Jordan, where none had been reported since 1988. Of these, 17 (50%) of 34 patients had received at least three doses of oral poliovirus vaccine (OPV3). The first and 2 subsequent case-patients were children of Pakistani migrant workers, and the first 8 and a total of 27 (75%) case-patients resided in or near the Jordan Valley. A seroepidemiologic study of 987 children in all regions of Jordan was performed to assess OPV3 coverage and immune response to OPV. Although OPV3 coverage by 12 months of age was high (96%) in the general population, coverage was lower among Pakistani (21%), Bedouin (63%), and Gypsy (9%) children (P < .001). Seroprevalences for poliovirus type 3 were 71% in the Jordan Valley versus 81% in other regions after 3 doses of OPV (P < .06) and 77% in the Jordan Valley versus 98% in other regions after 5 doses of OPV (P < .001). This outbreak demonstrates the importance of achieving high seroimmunity to infection in all geographic areas to prevent the reintroduction and spread of imported strains of wild poliovirus.

Case-Control Studies

Seroprevalence of antibody against poliovirus in inner-city preschool children. Implications for vaccination policy in the United States.

OBJECTIVES: To assess susceptibility to poliomyelitis in selected inner-city preschool children in the United States and to estimate the contribution of secondary spread of live attenuated oral poliovirus vaccine virus to type-specific immunity. DESIGN: Cross-sectional seroprevalence study. METHODS: Serum neutralizing antibody levels against poliovirus types 1, 2, and 3 were analyzed according to vaccination status, age, and other sociodemographic variables. SETTING: Hospital and satellite clinics serving inner-city populations in Houston, Tex, and Detroit, Mich, 1990 to 1991. PARTICIPANTS: A total of 526 children aged 12 to 47 months seeking medical care were enrolled in the seroprevalence study; 144 children aged 12 to 35 months without a history of previous oral poliovirus vaccination were enrolled in the secondary spread study. RESULTS: Seropositive rates were similar in children in both cities, ranging from about 80% for types 1 and 3 in 12- to 23-month-old children to more than 90% in those aged 36 to 47 months. The most important predictor of seropositivity was the number of doses of oral poliovirus vaccine received (P < .01), with levels approximately 90% for all 3 serotypes among children who had received 3 or more doses. In children likely to have been unvaccinated, seropositive rates ranged from 9% to 18% for poliovirus types 1 and 3 and from 29% to 42% for type 2; secondary spread of vaccine virus appeared to have occurred among children who had previously received 1 dose or less but not those with 2 or more doses. CONCLUSIONS: Levels of immunity to poliovirus among inner-city preschoolers are high and may be predicted by the number of doses of oral poliovirus vaccine received. Secondary spread of the vaccine virus plays a modest role in increasing polio immunity in inner-city populations, especially against types 1 and 3. This role will decrease in importance if the recently attained high levels of immunization coverage in the United States are sustained and if the risk of importation of wild poliovirus continues to diminish.

Antibodies, Viral

Changing levels of measles antibody titers in women and children in the United States: impact on response to vaccination. Kaiser Permanente Measles Vaccine Trial Team.

OBJECTIVES: In the United States, younger women are more likely to have immunity to measles from vaccination and are less likely to have been exposed to the wild virus than are older women. To evaluate changes in measles antibody titers in women in the United States and children's responses to measles vaccination, we analyzed data from a measles vaccine trial. METHODS: Sera collected from children before vaccination at 6, 9, or 12 months of age and from their mothers were assayed for measles antibodies by plaque reduction neutralization. Responses to vaccination with Merck Sharp & Dohme live measles virus vaccines at 9 months (Attenuvax) and 12 months (M-M-R II) were also analyzed. RESULTS: Among women born in the United States (n = 614), geometric mean titers (GMTs) of measles antibodies decreased with increasing birth year. For those born before 1957, 1957 through 1963, and after 1963, GMTs were 4798, 2665, and 989, respectively. Among women born outside of the United States (n = 394), there were no differences in GMTs by year of birth. Children of younger women born in the United States were less likely than those of older women to be seropositive at 6, 9, or 12 months. The response to the vaccines varied by maternal birth year for children of women born in the United States. Among 9-month-old children, 93% of those whose mothers were born after 1963 responded, compared with 77% and 60% of those whose mothers were born in 1957 through 1963 and before 1957, respectively. Among 12-month-old children, 98% of those born to the youngest mothers responded, compared with 90% and 83% of those whose mothers were born in 1957 through 1963 and before 1957. The responses of children of women born outside of the United States were not associated with maternal year of birth. CONCLUSIONS: An increasing proportion of children in the United States will respond to the measles vaccine at younger ages because of lower levels of passively acquired maternal measles antibodies.

Adult

Evaluation of house-to-house versus fixed-site oral poliovirus vaccine delivery strategies in a mass immunization campaign in Egypt.

Among poliomyelitis eradication activities recommended by WHO are national immunization days. Most campaigns have delivered oral poliovirus vaccine (OPV) from fixed sites, reaching 80-90% of target populations. Although house-to-house vaccination provides nearly universal coverage, countries have been reluctant to use this approach because it is considered more costly and logistically difficult. To quantify the cost-effectiveness of both these strategies, we compared the vaccine coverage and vaccination costs per child for house-to-house and fixed-site delivery (38% and 13% higher, respectively), the costs per child vaccinated were similar. This was due primarily to the high coverage levels achieved in house-to-house delivery (100% versus 86%) and the reduced vaccine wastage. Vaccinating children at highest risk of infection was only 25-50% as expensive on a per child basis using house-to-house delivery, since such children were less likely to visit fixed sites. These findings may not be generalizable to other countries where labour costs are higher and the population density lower; however, house-to-house delivery may prove to be the most cost-effective eradication strategy by ensuring universal access to immunization.

Child Health Services

Paralytic poliomyelitis in Romania, 1984-1992. Evidence for a high risk of vaccine-associated disease and reintroduction of wild-virus infection.

Although poliomyelitis due to wild-virus infection has virtually disappeared from Romania, with no cases having been documented between 1984 and 1989, vaccine-associated paralytic poliomyelitis has been reported at very high rates for over two decades. In November 1990, to decrease the risk of vaccine-associated paralytic poliomyelitis, oral poliovirus vaccine produced in Romania was replaced by imported oral vaccine made by a Western European manufacturer. To better quantify the risk of vaccine-associated paralytic poliomyelitis and the impact of the change in vaccine manufacturer, the authors reviewed clinical, epidemiologic, and laboratory data on poliomyelitis cases that occurred in Romania from 1984 to 1992. Poliovirus isolates were characterized at the US Centers for Disease Control and Prevention. During the period 1984-1992, 132 confirmed cases of paralytic poliomyelitis were reported in Romania, of which 13 were classified as wild-virus-associated, 93 as vaccine-associated, and 26 as "of unknown origin." Wild type 1 poliovirus was isolated during 1990-1992 from nine of 13 (69%) cases in an outbreak that occurred primarily among undervaccinated gypsy children. Vaccine-associated cases were epidemiologically and virologically distinct from wild-virus cases. Of the 93 vaccine-associated cases, 45 children were recipients and 48 were contacts. The overall risk of vaccine-associated paralytic poliomyelitis in Romania (1 case per 183,000 doses of oral poliovirus vaccine distributed) was 14-fold higher than the risk in the United States. The risks of recipient vaccine-associated paralytic poliomyelitis related to the first dose of oral vaccine were similar for Romanian and imported vaccine (1 case per 95,000 doses and 1 case per 65,000 doses, respectively), as were the total risks of vaccine-associated paralytic poliomyelitis. These findings definitively demonstrate a substantially elevated risk of vaccine-associated paralytic poliomyelitis in Romania which was not affected by a change in oral poliovirus vaccine manufacturer.

Child, Preschool

Influenza vaccination programs for elderly persons: cost-effectiveness in a health maintenance organization.

OBJECTIVE: To estimate the cost-effectiveness and net medical care costs of programs for annual influenza vaccinations for the elderly in a health maintenance organization (HMO). DESIGN: Population-based, case-control study. SETTING: The Northwest Region of Kaiser Permanente, a prepaid group practice HMO in Portland, Oregon. PARTICIPANTS: Kaiser Permanente members 65 years of age and older who had at least 1 month of HMO eligibility during any of nine influenza seasons in the 1980s. MEASUREMENTS: The HMO's costs for providing medical care and conducting vaccination programs were estimated using accounting data. RESULTS: 32% of high-risk elderly persons and 22% of non-high-risk elderly persons received influenza vaccinations. Aggregate vaccine effectiveness in preventing pneumonia and influenza hospitalizations was 30% (95% CI, 17% to 42%) for high-risk and 40% (CI, 1% to 64%) for non-high-risk elderly persons. The net savings to the HMO per vaccination was $6.11 for high-risk elderly persons and $1.10 for all elderly persons. The HMO incurred a net cost of $4.82 per vaccination for non-high-risk elderly persons. CONCLUSIONS: Influenza vaccination rates in this HMO were relatively low for high-risk elderly persons. The medical care costs saved by preventing pneumonia and influenza through vaccination of high-risk elderly persons provide a compelling rationale to increase compliance with recommendations for annual influenza vaccination. Indirect benefits, such as prevention of suffering, incapacity, and lost wages, are likely to compensate for the small net cost of vaccinating non-high-risk elderly persons.

Aged