Brief report. Placental transfer of IgG antibodies against Haemophilus influenzae type b capsular polysaccharide in Brazilian term and preterm newborns

The b-CAPSA I capsular polysaccharide vaccine for Haemophilus influenzae type b was given to 87,541 children 2 through 5 years of age in the Kaiser Permanente Medical Care Program, and the children were then followed using a multiple modality surveillance. Phase 1 consisted of 24-hour recall of immediate side effects which were recorded on questionnaires given to families of 13,500 children. Local side effects were found to be uncommon: 2.3% had a temperature of ≥38.3°C (≥101°F); 4.8% had local erythema, 2.9% local swelling, and 12.6% local tenderness; two children had wheezing shortly after immunization. In Phase 2, 30 days after immunization, questionnaires were mailed to parents of all 87,541 children, who were asked to respond to questions about illnesses and health care. Phase 3 consisted of active surveillance of patient health care use by physicians and nurses during the 30 days after immunization. During the 30-day reporting periods, there were 40 hospitalizations, including one for wheezing and one for febrile seizure. Of the 40 hospitalizations, only the one for wheezing was believed by the admitting physician to be probably associated with vaccine administration. Three children had seizures within 30 days of immunization. None of the seizures was believed by the reporting physician to be associated with immunization. Adverse effects of the vaccine were mild, limited to local reactions and occasional temperature elevation; bronchospasm after immunization occurred rarely.

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Disease Caused by Haemophilus influenzae Type b in the Immediate Period After Homologous Immunization: Immunologic Investigation

PEDIATRICS ◽

10.1542/peds.85.4.698 ◽

1990 ◽

Vol 85 (4) ◽

pp. 698-704

Author(s):

Sunil K. Sood ◽

Robert S. Daum

Keyword(s):

United States ◽

Haemophilus Influenzae ◽

Capsular Polysaccharide ◽

The United States ◽

Invasive Disease ◽

Haemophilus Influenzae Type ◽

Haemophilus Influenzae Type B ◽

Type B ◽

Background Rate ◽

Protein Conjugate

Several Haemophilus influenzae type b vaccines have been licensed and recommended for administration to children in the United States. These vaccines have consisted of purified polyribosylribitol-phosphate (PRP), the capsular polysaccharide of H influenzae type b,1 alone or covalently bound to one of several carrier proteins. Two of these saccharide-protein conjugate vaccines are now licensed, a polysaccharide-diphtheria toxoid conjugate (PRP-D)2 and an oligosaccharide-mutant diphtheria toxin conjugate (HbOC).3 Two others, a polysaccharide- Neisseria meningitidis outer membrane protein conjugate (PRP-OMPC)4 and a polysaccharide-tetanus toxoid conjugate (PRP-T),5 are currently in clinical trials. One concern with the use of PRP vaccine was the suggestion that the incidence of invasive disease caused by H influenzae type b in the immediate period after immunization might be increased; this idea was supported by evidence from several sources. In a case-control study of the efficacy of PRP vaccine, Black et al6 found that 4 children were hospitalized for invasive disease within 1 week of immunization, a rate of invasive disease 6.4 times greater (95% confidence interval [CI], 2.1 to 19.2) than the background rate in unvaccinated children. In Minnesota, the relative risk for invasive disease in the first week after immunization was 6.2 (95% CI, 0.6 to 45.9),7 and the results of a study conducted by the Centers for Disease Control in six areas of the United States revealed a 1.8-fold (95% CI, 0.3 to 10.2) increase in the occurrence of invasive disease caused by H influenzae type b in the first week after immunization.8 Moreover, among 16 cases of disease caused by H influenzae type b occurring within 14 days of immunization that were passively reported to the FDA,9 10 were clustered within the first 72 hours.

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