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Biomedical subjects

E L Anderson

Publications and source records attributed to E L Anderson.

At least 55 records · Page 3Linked to original sources

Safety and immunogenicity of meningococcal A and C polysaccharide conjugate vaccine in adults.

A meningococcal vaccine containing group A and C polysaccharides conjugated to CRM197 was evaluated in 50 adults. Vaccinees were entered into one of five groups: 30 adults received a single dose of either 22, 11, or 5.5 micrograms of the conjugated A-C vaccine; 10 received an approved meningococcal vaccine; and 10 received saline injections. Local and systemic reactions to vaccines were recorded, and immune responses were determined. The experimental meningococcal vaccine was well tolerated, with the most frequent reaction being pain at the injection site. Both A and C polysaccharide components of the experimental vaccine were highly immunogenic, and total antibody concentrations 1 month postvaccination were not significantly different from the mean antibody concentrations among adults given the approved meningococcal vaccine. In addition, significant rises in immunoglobulin G, A, and M antibodies to both A and C polysaccharides occurred. Antibody concentrations measured at 6 and 12 months postvaccination had declined but remained significantly higher than prevaccination concentrations. Postvaccination meningococcal group C functional antibody activity increased more than 600-fold for both the polysaccharide and the conjugate vaccines. Further studies of this conjugated meningococcal vaccine are indicated for young children and infants.

Adolescent↗

Acellular and whole-cell pertussis vaccines as booster doses: a multicenter study.

OBJECTIVE: To compare the safety and immunogenicity of a variety of acellular (AC) and whole-cell (WC) pertussis vaccines combined with diphtheria and tetanus toxoids. METHODS: Standard enrollment and reaction forms were used at five sites, and serologic evaluation was performed at a single site. Nine AC (Massachusetts Public Health Laboratories, Biocine Sclavo recombinant pertussis toxoid [PT], Connaught/BIKEN, Lederle three-component, Biocine Sclavo recombinant three-component, SmithKline Beecham three-component, Porton three-component, Takeda-Wyeth, and Connaught multicomponent), and three WC (Connaught Laboratories, Lederle Laboratories, and Massachusetts Public Health Laboratories) were studied. All AC contained varying concentrations of PT; some vaccines also contained filamentous hemagglutinin (FHA), pertactin, and/or agglutinogens. RESULTS: Two hundred forty children, aged 16 to 21 months and 4 to 6 years, were enrolled at five sites. Significantly less fever, redness, swelling, pain, limp, and use of pain medication were noted following AC compared with WC. Significant increases in antibody to PT were seen following all vaccines. Significant rises in FHA antibody were seen following all WC and the seven AC that contained FHA. Postbooster PT antibody levels were similar among the AC groups, regardless of the amount of PT administered (between 3.5 and 25 micrograms per dose). The dose of FHA did not affect PT antibody response. Infants primed with WC who were boosted with a monocomponent PT vaccine did not manifest a significant antibody response to FHA. CONCLUSION: The rate of adverse reactions was not a function of the number of antigens or the antigen quantity in the acellular vaccines, and antibody responses following AC were similar or better than antibody responses following WC. These results support the further evaluation of these vaccines in a larger National Institute of Allergy and Infectious Diseases-sponsored study in infants.

Antibodies, Bacterial↗

Induction of immunologic memory in infants primed with Haemophilus influenzae type b conjugate vaccines.

The ability of different Haemophilus influenzae type b conjugate vaccines to induce immunologic memory was compared in 381 infants who were vaccinated with one of three conjugate vaccines beginning at 2 months of age. All infants were vaccinated with unconjugated type b capsular polysaccharide, polyribosylribitol phosphate (PRP), at 12 months. In each group, high antibody responses were detected by 6-9 days after vaccination. One month after receiving PRP, infants primed with PRP conjugated to the outer membrane protein of Neisseria meningitidis or PRP oligomers conjugated to the cross-reactive mutant diphtheria protein, CRM197, had twofold higher total anti-PRP antibody concentrations than did infants primed with PRP conjugated to tetanus toxoid (P < .005). After the conjugate and the PRP boost, notable differences were present among vaccine groups with respect to the magnitude of the IgG anti-PRP antibody concentrations and light chain variable region usage as determined by idiotypic analysis. Thus, each of the conjugate vaccines primed infants for the ability to evoke memory antibody responses to PRP, but qualitative and quantitative differences in priming induced by different vaccines may affect their ability to confer protection against disease.

Bacterial Outer Membrane Proteins↗

Immunogenicity of purified F glycoprotein of respiratory syncytial virus: clinical and immune responses to subsequent natural infection in children.

Purified F glycoprotein from respiratory syncytial virus (RSV, subgroup A antigenic type) was evaluated in 18- to 36-month-old children as a vaccine. Children had been previously infected with RSV during natural outbreaks of the virus. Single injections of 5, 20, or 50 micrograms of protein resulted in greater than eightfold increases in ELISA and neutralizing antibodies. Second doses of vaccine did not result in further boosts in antibody. Neutralizing antibodies increased not only to the A2 and Long strains (subgroup A strains) but also to strain 18537 (subgroup B). Four of 11 vaccinees became naturally infected during the subsequent RSV outbreak, suggesting that the vaccine was not effective in preventing recurrent RSV infections. Severe illnesses did not occur, indicating that there was not an increase of severity of infection following vaccine in seropositive children. Only 1 of 8 vaccinees tested had fourfold increases in nasal wash IgA to RSV after immunization. Vaccine strategies to stimulate secretory antibodies as well as circulating neutralizing antibodies to RSV need to be developed.

Animals↗

Differences in the immunogenicity of three Haemophilus influenzae type b conjugate vaccines in infants.

OBJECTIVE: To compare the immunogenicity of three Haemophilus influenzae type b (Hib) conjugate vaccines in infants residing in different geographic areas. DESIGN: A multicenter, randomized immunogenicity trial with sera assayed in one laboratory without knowledge of vaccine brand status. In Minneapolis and Dallas, infants were vaccinated at 2, 4, and 6 months of age; in St. Louis, infants were vaccinated at 2 and 4 months of age. SUBJECTS: A convenience sample of 458 infants recruited largely from private pediatric practices. MEASUREMENTS AND RESULTS: At each of the study sites, the respective trends between the anticapsular antibody responses of the infants assigned to the different conjugate vaccine groups were similar. After one or two doses, Hib polysaccharide conjugated to outer membrane protein complex of Neisseria meningitidis (PRP-OMP) was more immunogenic than Hib polysaccharide-tetanus toxoid conjugate (PRP-T), or Hib oligomers conjugated to the mutant diphtheria toxin CRM197 (HbOC) (p less than 0.001). After two doses, PRP-T was more immunogenic than HbOC (p less than or equal to 0.001). After three doses there was no significant difference in the geometric mean antibody concentrations of the three groups, and 88% to 97% of the infants had greater than 1.0 microgram/ml of antibody. The HbOC vaccine elicited a 10-fold lower antibody response after two doses (0.45 micrograms/ml vs 5.9 micrograms/ml) and a threefold lower antibody response after three doses (6.3 micrograms/ml vs 22.9 micrograms/ml) than observed by us previously with a prelicensure lot of this vaccine (p less than 0.001). Because of these low responses, the infants in St. Louis who received two doses of HbOC were revaccinated with unconjugated PRP at a mean age of 8.9 months. This group was immunologically primed, as evidenced by a 10-fold increase in geometric mean antibody concentration after vaccination at an age when unprimed infants do not normally respond to this vaccine. CONCLUSIONS: In infants in three geographic regions, PRP-OMP elicited earlier acquisition of serum antibody than the other two conjugate vaccines; however, after three doses the antibody concentrations of the three groups were not significantly different. The reason for the markedly lower immunogenicity of HbOC vaccine than reported previously is unknown.

Age Factors↗

Immunization of infants and young children with live attenuated trivalent cold-recombinant influenza A H1N1, H3N2, and B vaccine.

Seventeen triply seronegative infants and young children, and 15 infants and young children seropositive to all three influenza virus strains were vaccinated intranasally with 10(5) TCID50 of each of three (H1N1, H3N2, and B) live attenuated, cold-adapted influenza vaccine strains. Seventeen controls were given placebo. Vaccination with trivalent influenza vaccine was not associated with adverse reactions in triply seronegative or seropositive children. Overall, 12 (71%), 13 (76%), and 13 (76%) of seronegative children were infected by H1N1, H3N2, or B vaccine viruses, respectively, as indicated by viral shedding or by hemagglutination inhibition assay or ELISA antibody response. Of the triply seronegative children, 47% shed all three viruses; 7 children had an antibody rise to all three vaccine viruses and 4 shed all three viruses. A dose of 10(4.4) - 10(5.0) TCID50 of each of three intranasally administered vaccine viruses was safe, immunogenic and antigenic; however, strategies to increase the proportion of children infected by each of the vaccine viruses should be studied, including higher doses and multiple doses of live trivalent vaccine.

Administration, Intranasal↗

Evaluation of a live attenuated, cold-adapted parainfluenza virus type 3 vaccine in children.

Cold passage 18 (CP18) parainfluenza virus type 3 (PIV-3) vaccine was evaluated in a double-blind, randomized, placebo-controlled study of 95 infants and young children. None of 19 seropositive older children 41 to 124 months old became infected when 10(6) 50% tissue culture infective doses (TCID50) of vaccine virus was administered intranasally. Two of nine and seven of twenty-four young seropositive children given 10(5) or 10(6) TCID50 of CP18 PIV-3, respectively, became infected. Each of four seronegative young children became infected, as indicated by virus shedding and antibody response, when given 10(6) TCID50 of CP18 PIV-3 intranasally. Illness was not observed in seropositive children. Two of the four seronegative children developed a mild illness characterized by rhinorrhea and wheezing on auscultation; none had fever. In one case, vaccine virus spread from a vaccine to a sibling control but did not cause illness. The vaccine is attenuated relative to wild-type PIV-3, but additional attenuation will be required to achieve a satisfactory PIV-3 vaccine.

Adaptation, Physiological↗

Evaluation of a cold-adapted influenza B/Texas/84 reassortant virus (CRB-87) vaccine in young children.

A cold-adapted (ca) influenza B reassortant virus vaccine that contained the six internal RNA segments from influenza B/Ann Arbor/1/66 ca virus and the neuraminidase and hemagglutinin genes from wild-type influenza B/Texas/1/84 virus was evaluated in children ranging in age from 8 months to 14 years. The children were vaccinated intranasally with doses ranging from 10(3.2) to 10(6.2) 50% tissue culture infective doses (TCID50). Thirty children were seropositive, and 26 were seronegative. Thirty-three children participated as unvaccinated controls. The vaccine was well tolerated by both seronegative and seropositive children. The amount of virus required to infect 50% of seronegative children was approximately 10(4.5) TCID50. Vaccine viruses recovered from airway secretions retained temperature-sensitive and cold-adapted characteristics. The results of this study indicate that the vaccine virus, influenza B/Texas/84 ca reassortant virus, is attenuated, immunogenic, and phenotypically stable when given to young seronegative children.

Adaptation, Biological↗

Human health risks associated with asbestos abatement.

Upperbound lifetime excess cancer risks were calculated for activities associated with asbestos abatement using a risk assessment framework developed for EPA's Superfund program. It was found that removals were associated with cancer risks to workers which were often greater than the commonly accepted cancer risk of 1 x 10(-6), although lower than occupational exposure limits associated with risks of 1 x 10(-3). Removals had little effect in reducing risk to school populations. Risks to teachers and students in school buildings containing asbestos were approximately the same as risks associated with exposure to ambient asbestos by the general public and were below the levels typically of concern to regulatory agencies. During abatement, however, there were increased risks to both workers and nearby individuals. Careless, everyday building maintenance generated the greatest risk to workers followed by removals and encapsulation. If asbestos abatement was judged by the risk criteria applied to EPA's Superfund program, the no-action alternative would likely be selected in preference to removal in a majority of cases. These conclusions should only be interpreted within the context of an overall asbestos risk management program, which includes consideration of specific fiber types and sizes, sampling and analytical limitations, physical condition of asbestos-containing material, episodic peak exposures, and the number of people potentially exposed.

Air Pollutants↗

Characteristics of a population volunteering for human immunodeficiency virus immunization. NIAID AIDS Clinical Trials Network.

A total of 166 volunteers for an AIDS vaccine study (Vaxsyn, baculovirus produced recombinant GP160; MicroGeneSys Inc, West Haven, Connecticut, USA) were interviewed and examined. Blood was collected for routine laboratory testing as well as T-cell counts, HIV ELISA (EIA), Western blot (WB) and p24 Ag. Eighty-five men (mean age 22.2 years, range 18-42) and 81 women (mean age 23.9 years, range 17-50) volunteered; 130/166 (78%) were university students. Most had learned of the study from news media (55%), friends or workplace (37%). The most common causes for exclusion were the presence of indeterminate WB (26.5%) or a change of mind after the initial interview (24%). Other causes were abnormal cell count and differential (7.2%), elevated alanine aminotransferase (3.6%), positive hepatitis B antibody (3.6%), abnormal urinalysis (3.4%), recent venereal disease (3.0%), T4 cell count less than 400 (1.9%), abnormal chest X-ray (1.7%), recognized high-risk behaviour (1.7%), multiple sex partners (1.2%), positive rapid plasma reagin test (1.2%), failure to meet age criteria (1.2%), unable to be available for entire study (1.2%), abnormal physical examination (0.6%) and positive p24 Ag (0.6%). No volunteers had positive EIA, but 14.5% had more than one reason for exclusion. Even in a community with low prevalence for HIV, a large majority of healthy heterosexual volunteers can be expected to be ineligible for enrollment in HIV vaccine trials. An average of 4.8 volunteers were screened for each of 12 vaccinees chosen.

AIDS Vaccines↗

Evaluation of cold-recombinant influenza A/Korea (CR-59) virus vaccine in infants.

Twenty-four infants 5 to 13 months of age were intranasally vaccinated with a live cold-recombinant influenza A/Korea (CR-59, H3N2) virus vaccine. Nineteen infants served as controls. The inocula ranged from 10(3.2) to 10(6.2) 50% tissue culture infective doses (TCID50) per infant. Zero of six, one of four, seven of ten, and four of four infants receiving 10(3.2), 10(4.2), 10(5.2), and 10(6.2) TCID50, respectively, were infected by the intranasal vaccine. The amount of virus required to infect 50% of infants was calculated to be 10(4.6) TCID50. The occurrence of fever, respiratory illness, and otitis media was common among both controls and vaccinees in the postinoculation period. Maternal antibody was present in low titers in some infants and did not inhibit replication of the vaccine virus.

Administration, Intranasal↗

Scientific trends in risk assessment research.

The use of risk assessment approaches to evaluate the effects of toxic chemicals had its primary origin in 1976 when the U.S. Environmental Protection Agency (EPA) adopted the first federal guidelines to commit a major regulatory agency to risk assessment approaches for the evaluation of suspect carcinogens. The accompanying policy statement also adopted a risk management policy, which acknowledged that the agency would accept risk in making public health policy decisions; in essence, this represented a primary departure from the zero-risk goal that had dominated the first half of the environmental movement of the 70s. The approach adopted in 1976 was based on the experience of risk assessment approaches used for assessing low-dose-radiation effects on human health. To be certain that no public health risk be underestimated, particularly in light of the prior zero-risk goal, the practice of risk assessment for the first decade relied heavily on extremely protective assumptions in all aspects of the assessment process. For example, these assumptions included ranking the weight-of-evidence according to results in all related studies without regard for distinctions of tumor end point relevance to humans and the possibility that low-dose effects at environmental exposures might not be the same as high-dose effects. For low-dose-response characterization, the practice has been to characterize a plausible upper bound on risk by the use of a low-dose linear non-threshold dose-response curve. Exposure assessment likewise relied on maximum plausible assumptions to characterize exposure. More recently, more attention is being paid to developing accurate scientific databases that advance almost every aspect of the risk assessment process in the direction of more accurate risk characterization. This paper will discuss the recent trends in weight-of-evidence characterization, dose-response modeling, and exposure assessment and will compare the outcomes of these refined assessments to those evaluations that have relied on the earlier, conservative approaches. In essence, if the practices of the first decade for establishing plausible upper bounds on the risk were accurate, improved scientific data by and large should be expected to lower the overall theoretical risk. Indeed, this is the case when recent risk assessment research is applied but there are examples to the contrary. This paper represents a survey of recent trends and applications.

Animals↗

Prevention of pertussis.

Pertussis (whooping cough) is an acute respiratory disease caused by Bordetella pertussis. It occurs worldwide and is an important cause of morbidity and mortality in areas where immunization rates are low, particularly among children less than 1 year of age. The characteristic presentation of pertussis is paroxysmal coughing followed by a long inspiratory effort that produces the classic whoop. Lymphocytosis is frequently present. Complications include pneumonia and seizures secondary to hypoxia. The paroxysmal and convalescent stages of the illness can each last several weeks. Transmission occurs readily by respiratory droplets, and atypical or mild cases in older children and adults can be important in spread of the infection. Isolation, early erythromycin therapy, and erythromycin prophylaxis can reduce transmission, but vaccination is the primary means of control. An inactivated whole cell suspension of the bacterium has been an effective vaccine for protecting against pertussis since the 1950s, but whole cell vaccine may allow mild infections to occur and has been associated with local and systemic reactions that have eroded public acceptance. Component or acellular pertussis vaccines that are less reactogenic have been in use in Japan since 1981 and appear to be effective there. Development of an acellular preparation that is equally or more efficacious than whole cell vaccine may be possible, but clinical trials for measurement of protection against pertussis are difficult and trials with new pertussis vaccines will have to be carefully performed to avoid the controversies generated by earlier trials.

Adult↗

Productivity measurement for clinical nurse specialists.

The clinical nurse specialists (CNSs) at an 814-bed tertiary care center have collaborated to develop a method for measuring and evaluating productivity of the CNS role. This method, which uses the CIPP Evaluation Model as a framework, parallels the nursing process and is outcome oriented. The applicability of this method to other fixed positions may be of interest to nursing managers and administrators.

Efficiency↗

Effects of ozone and soil water deficit on roots and shoots of field-grown soybeans.

Water-stressed and well-watered soybean (Glycine max cvs. Williams and Corsoy) plants were exposed to increasing seasonal doses of ozone (O(3)) using open-top field chambers and ambient air plots. Chamber O(3) treatments included charcoal filtered (CF) air, non-filtered (NF) air, NF + 0.03, NF + 0.06 and NF + 0.09 microl litre(-1) O(3). Soil water potentials measured at 25 and 45 cm averaged -0.40 MPa and -0.05 MPa, respectively, for the plots in the water-stressed and well-watered series. Total root length/core, root length densities, and biomasses (dry weights) were determined. With Williams, a very popular cultivar in recent years, total root length for all O(3) treatments averaged 58% more under water-stress conditions than in well-watered plots, but the range was from 136% to 11% more for NF air and NF + 0.09 microl litre(-1) O(3), respectively. Increasing the O(3) exposure dose did not affect root lengths or weights in the well-watered series. With Corsoy, water stress did not significantly increase root development. In both soil moisture regimes, with both cultivars, there was a linear decrease in seed yield and top dry weight as the O(3) exposure dose increased.

Journal Article↗

Differences in reactogenicity and antigenicity of acellular and standard pertussis vaccines combined with diphtheria and tetanus in infants.

Clinical and serological responses of infants to primary immunization with diphtheria-tetanus-pertussis (DTP) vaccine containing components of acellular pertussis vaccine (DTP-AC) were compared in a double-blind study with responses of infants receiving whole-cell DTP vaccine (DTP-WC). Three doses of either DTP-AC containing lymphocytosis-promoting factor (LPF) and filamentous hemagglutinin (FHA) or DTP-WC vaccine were given to infants at two, four, and six months of age. Nineteen infants received DTP-AC vaccine, and 20 infants received DTP-WC vaccine. Significantly more infants who received DTP-WC vaccine manifested fever, swelling, and/or total reactions than did infants who received DTP-AC vaccine. Infants who received DTP-AC vaccine had comparable antibody titers to LPF and significantly higher titers to FHA after three immunizations, as compared with the infants who received DTP-WC vaccine (P less than or equal to .001). The DTP-WC vaccine stimulated higher pertussis agglutination titers (P = .04) than did DTP-AC. The DTP-AC vaccine was immunogenic and significantly less reactogenic in infants than was the currently used DTP-WC vaccine.

Antibodies, Bacterial↗