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Biomedical subjects

P Olin

Publications and source records attributed to P Olin.

At least 55 records · Page 3Linked to original sources
PubMed1990

Secondary analyses of the efficacy of two acellular pertussis vaccines evaluated in a Swedish phase III trial.

A placebo-controlled efficacy trial of two acellular pertussis vaccines carried out in Sweden in 1986-87 used culture confirmation as the principal case definition. However, the sensitivity of pertussis culture is low, and secondary analyses using more sensitive serological diagnostic criteria have therefore been carried out. These analyses confirm that vaccination with pertussis toxoid alone does protect against typical whooping cough with laboratory confirmation, but show that it does not protect against infection or colonization. There is evidence that the addition of filamentous haemagglutinin provides some protection against infection. Bacterial isolation rates were lower in vaccinated than unvaccinated children with serologically confirmed pertussis and increased with disease severity.

Child↗
PubMed1988

Protective efficacy of a whole cell pertussis vaccine.

A trial of the efficacy of a plain whole cell pertussis vaccine was conducted in Sweden. In this non-blinded trial 525 infants aged 2 months who were born on days with an even number received three doses of vaccine one month apart and 615 infants of the same age who were born on days with an odd number were enrolled as controls. During the 18 months of follow up there were 55 cases of pertussis. The attack rate was 1.5% (8/525) among the vaccinated children and 7.6% (47/615) among the unvaccinated children (p less than 0.001). The estimated efficacy of the vaccine was 80% (95% confidence interval 58 to 90). The estimated efficacy of pertussis vaccine was similar to that observed in British trials over 30 years ago.

Clinical Trials as Topic↗
PubMed1988

Mortality and morbidity from invasive bacterial infections during a clinical trial of acellular pertussis vaccines in Sweden.

A double blind placebo-controlled efficacy trial of two acellular pertussis vaccines was conducted in 3801 6- to 11-month-old children. Four vaccinated children died during 7 to 9 months follow-up as a result of Haemophilus influenzae type b meningitis, heroin intoxication with concomitant pneumonia, suspected septicemia, and Neisseria meningitidis Group B septicemia. From the actual death rate in children belonging to the same birth cohort in Sweden that could have been eligible for the trial, one death was expected among vaccinated children. Several investigations were carried out to examine the possibility that the deaths could be causally related to the vaccination. The relative risk for hospitalization due to systemic or respiratory infections was 1.07 (95% confidence interval, 0.95 to 1.20) and 0.83 (95% confidence interval, 0.64 to 1.08) in the vaccine groups as compared with the placebo group. Subsets of the population were studied for signs of immunosuppression. There was no indication of immunoglobulin deficiency or any sign of clinically significant leukopenia or lymphocytosis in vaccine recipients. The results of this analysis provide no evidence for a causal relation between vaccination with the studied acellular pertussis vaccines and altered resistance to invasive disease caused by encapsulated bacteria. The hypothesis that the two variables are related, however, cannot be refuted from these data.

Antibodies, Bacterial↗
PubMed1988

Primary immunization of infants with an acellular pertussis vaccine in a double-blind randomized clinical trial.

The rate of adverse reactions and the immunogenicity of a two-component acellular pertussis vaccine as compared with a plain whole-cell vaccine and a placebo were evaluated for primary immunization in 319 6-month-old infants in a double-blind randomized clinical trial. The acellular vaccine produced few and mild systemic and local reactions. Fever (greater than or equal to 38 degrees C) occurred in 6% to 8% of acellular vaccinees as opposed to 25% to 37% of whole-cell vaccinees. Redness (greater than or equal to 1 cm) appeared in 2% to 13% of the acellular vaccine and 24% to 32% of the whole-cell vaccine recipients. Antibody response to pertussis toxin measured in a neutralization test was obtained in 97% to 100% of the infants receiving either two or three doses of the acellular vaccine as compared to 59% after three doses of whole-cell vaccine.

Antitoxins↗
PubMed1988

Invasive bacterial infections during an efficacy trial of acellular pertussis vaccines--implications for future surveillance in pertussis vaccine programmes.

During a placebo controlled trial of acellular pertussis vaccines a cluster of invasive bacterial infections with fatal outcome occurred among vaccinated children as compared with unvaccinated Swedish children of the same birth cohort (4). Clinical and immunological studies did not support the hypothesis of an immunosuppressive effect of the vaccines, which would explain the deaths, but the hypothesis could not be refuted by the data. To evaluate the safety of acellular pertussis vaccines regarding rare severe events--in particular invasive infectious diseases--prospective studies seem to be needed, comparing very large groups. A coordinated and controlled vaccine programme during 1-2 years in most of Sweden combined with national reports of invasive infections may serve as a basis for such a study. A possible study design is given below.

Bacterial Infections↗
PubMed1987

A clinical trial of a monocomponent pertussis toxoid vaccine.

We compared a monocomponent pertussis toxoid vaccine preparation (JNIH-7) in a double-blind, randomized study with another component vaccine (JNIH-6) containing pertussis toxoid and filamentous hemagglutinin in equal proportions. Monocomponent pertussis toxoid vaccines have not been tested previously in children. This trial comprised 255 previously nonimmunized children 6 to 10 months old who were given two 0.5-mL subcutaneous injections of either vaccine four to five weeks apart. Prevaccination and postvaccination serum samples from 235 infants showed an antitoxin seroconversion rate of 100% in both groups. Adverse reactions were few and mild, with local reactions occurring more often after administration of the second dose and among recipients of the two-component vaccine (P less than .05).

Antibody Formation↗
PubMed1986

Preliminary data from a clinical trial (phase 2) of an acellular pertussis vaccine, J-NIH-6.

In the search for a new and better pertussis vaccine for general vaccination in Sweden, a clinical trial of an adsorbed acellular vaccine from Japan has been performed. The vaccine used was produced by Biken and contained only F-HA and the toxoid of pertussis toxin (LPF). The aims were: To demonstrate the serological response to primary vaccination of this adsorbed acellular vaccine in comparison to a plain whole cell vaccine. To compare the incidence of side reactions between the two types of vaccines and the adjuvant (aluminium phosphate) of the acellular vaccine used as placebo.

Adjuvants, Immunologic↗
PubMed1981

Screening for congenital hypothyroidism. I. Laboratory results of a pilot study based on dried blood samples collected for PKU screening.

A pilot study was performed to establish optimal conditions for nation-wide screening for congenital hypothyroidism in Sweden. The levels of T4 and TSH were determined by automated radioimmunoassay in the dried blood spots, routinely collected for PKU screening on the fifth postnatal day, from all 19 792 infants born in the Stockholm area during a 14-month period. To identify safe minimum recall criteria for routine use, infants were recalled if the TSH level was more than 30 mU/l of plasma or--if they were not preterm--the T4 concentration was less than -2 S.D. of the mean. Altogether 160 infants were recalled. Seven newborns with congenital hypothyroidism were identified, 6 with primary and one with secondary hypothyroidism. Five infants had decreased levels of thyroxine-binding globulin. The results of the follow-up analyses from recalled infants showed that determination of the reverse-T3 level may be of diagnostic value around the 23rd day of life. The results of the clinical investigation of recalled infants are reported in a subsequent paper and a programme for nation-wide screening for congenital hypothyroidism is proposed.

Congenital Hypothyroidism↗
PubMed1981

Screening for congenital hypothyroidism. II. Clinical findings in infants with positive screening tests.

In a pilot screening programme for congenital hypothyroidism, PKU filter paper blood samples from 20 000 infants born in Stockholm were analysed for TSH and T4 to identify optimal conditions for routine nationwide screening. Among 160 infants with positive screening tests, 7 infants (group I) had true-positive results, 6 had primary and one secondary hypothyroidism. The 153 infants with false-positive tests were divided into group II:74 infants with an isolated increased TSH level; group III: 71 infants with an isolated decreased T4 concentration; and group IV: 8 infants with increased TSH and decreased T4 levels. In group I the clinical signs and symptoms of hypothyroidism varied when the diagnosis was made at 3 weeks of age. The median hypothyroid index score was 8 (range 0--18). In groups II-IV most infants showed very few signs of hypothyroidism. The median hypothyroid index scores were 1, 1, and 0, respectively. Clinical findings were of little value in the individual case for distinguishing true from false positive screening tests. We suggest that nation-wide screening should be based on TSH analyses of PKU blood samples, with a cut-off level corresponding to 50 mU/l of plasma. Recall frequency will be less than 0.1%.

Congenital Hypothyroidism↗
PubMed1979

Quality of care: a tracer diagnosis study of acute otitis media, comparing a district paediatric service with paediatric and otolaryngology emergency departments.

Acute otitis media was used as a tracer condition for comparing patient care as regards patient satisfaction, compliance and medical outcome in a district paediatric office, an otolaryngological and a paediatric hospital emergency department. The initial work-up of the 216 patients studied at the three units was in good agreement with predefined standards. However, while the district paediatrician arranged a follow-up for all patients, the hospitals did so only in 10--30% of the visits. Parent satisfaction was significantly higher at the district office when the time spent waiting and the time the patient was with the doctor were kept constant. Urinary penicillin was not detected in 1/17 of district paediatric and in 6/19 of otological patients. Compliance with follow-up was also much higher at the district paediatrician. Medical outcome did not differ between the units. The majority of the parents expressed preference for the type of care given in a neighbourhood service. It is suggested that the criteria for adequate treatment of acute otitis media adapted for emergency departments may be revised in case easy access is provided to a medical centre offering continuity of care and proper follow-up. Studies of the quality of care have so far not managed to demonstrate a definite and positive relationship between the process of care, patient satisfaction and final medical results.

Adult↗
PubMed1979

Paediatric services within the primary health care system in suburban areas.

Results from a few studies on community paediatrics in suburbs of Stockholm are presented. Pattern of diagnoses, utilization of care and social and psychological team work are discussed. Goals of the paediatric service in the primary care are set up and a distribution of duties between different professionals is suggested.

Child↗
PubMed1979

Day care and respiratory infection.

Medical opinion on day care for young children since the 1940s is reviewed with emphasis on risks of respiratory illnesses. Recent knowledge about respiratory infections and the dissemination of viruses among day care children has (1) ascertained the importance of simple preventive measures; (2) modified the value of strict isolation of each child with respiratory symptoms, and (3) emphasized that medical treatment should be kept for complicated illnesses and a few particularly infection-prone children. Child health services, parents and day care personnel should develop principles for the care of children with minor respiratory illnesses, mainly leaving the responsibility for the sick child with the parents.

Child↗