Postlicensure surveillance for Haemophilus influenzae type b invasive disease after use of Haemophilus influenzae type b oligosaccharide CRM197 conjugate vaccine in a large defined United States population

1995 ◽  
Vol 14 (11) ◽  
pp. 978-981 ◽  
Author(s):  
HENRY R. SHINEFIELD ◽  
STEVE BLACK
Keyword(s):  
United States ◽  
Haemophilus Influenzae ◽  
Conjugate Vaccine ◽  
Invasive Disease ◽  
Haemophilus Influenzae Type ◽  
Haemophilus Influenzae Type B ◽  
Type B ◽  
United States Population

Comparative Immune Responses to Haemophilus influenzae Type b Polysaccharide and a Polysaccharide-Protein Conjugate Vaccine

PEDIATRICS ◽  
1990 ◽  
Vol 85 (4) ◽  
pp. 648-650
Author(s):  
Kwang Sik Kim ◽  
Victor K. Wong ◽  
Robert Adler ◽  
Evan A. Steinberg
Keyword(s):  
United States ◽  
Los Angeles ◽  
Haemophilus Influenzae ◽  
Conjugate Vaccine ◽  
The United States ◽  
Invasive Disease ◽  
Haemophilus Influenzae Type ◽  
Haemophilus Influenzae Type B ◽  
Healthy Children ◽  
Type B

Haemophilus influenzae type b is the most common cause of bacterial meningitis in children in the United States. Antibody to the capsular polysaccharide of this organism, polyribosylribitol-phosphate (PRP), is important in protecting against invasive disease. In 1985, H influenzae type b vaccine containing only PRP was licensed in the United States for use in children 24 to 59 months of age. Studies conducted in the United States and Finland have shown that PRP vaccine is safe and immunogenic in children older than 18 months of age.1,2 In Finland, an efficacy of approximately 80% was obtained when PRP vaccine was used to prevent invasive disease caused by H influenzae type b in children older than 24 months of age.3 The immunogenicity of the PRP vaccine in children 18 to 23 months of age, however, was not clearly established. Reported rates of seroconversion after receipt of a single dose of PRP vaccine ranged from 20% to 75%1.3-5 The purpose of our studies was to evaluate the immunogenicity y of PRP vaccines and of conjugate vaccine (PRP-Neisseria meningitidis outer membrane protein complex [PRP-OMPC]) in children from the Los Angeles area. First, we conducted a randomized, prospective study to compare the immunogenicity of the PRP vaccines produced by three manufacturers. A total of 147 healthy children between the ages of 18 and 58 months were recruited from Childrens Hospital of Los Angeles and Kaiser Foundation Hospital, Los Angeles, to receive, according to a prepared randomization schedule, 25 µg of the following PRP vaccines: Hib-Immune, lot 184-669, 190-654; Hib-Vax, lot 7L91071, 7D91043; or b-CAPSA I, lot M087BD, M068BC.

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

PEDIATRICS ◽  
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.

Protective Efficacy of Haemophilus influenzae Type b Polysaccharide Vaccine

PEDIATRICS ◽  
1990 ◽  
Vol 85 (4) ◽  
pp. 643-647
Author(s):  
Eugene D. Shapiro ◽  
Anne T. Berg
Keyword(s):  
United States ◽  
Haemophilus Influenzae ◽  
Protective Efficacy ◽  
The United States ◽  
Invasive Disease ◽  
Polysaccharide Vaccine ◽  
Haemophilus Influenzae Type ◽  
Haemophilus Influenzae Type B ◽  
Type B ◽  
Increased Risk

There has been uncertainty and controversy about the protective efficacy of Haemophilus influenzae type b polysaccharide vaccine almost since it first was licensed in the United States. This article will briefly review the available epidemiologic data about the protective efficacy of this vaccine in children with no recognized underlying illnesses. H influenzae type b polysaccharide vaccine was licensed in the United States in April 1985, based on the results of a randomized clinical trial that was conducted in Finland.1 That study indicated that the vaccine's protective efficacy was 90% against invasive disease caused by H influenzae type b in children 18 to 71 months of age. Authorities recommended that all children receive the vaccine at 2 years of age and that it be administered to children up to the age of 60 months.2,3 The Immunization Practices Advisory Committee also recommended that children at increased risk (such as those who attend group day care) receive the vaccine at 18 months and again at 24 months of age because of its inconsistent immunogenicity when administered to 18-month-old children.2 Soon after its licensure, however, reports of vaccine failures began to appear. In some instances the vaccine failure could be attributed to an identifiable immune deficiency.4,5 However, Granoff et al6 reported 54 apparently normal children who had received the H influenzae type b polysaccharide vaccine but subsequently developed invasive disease caused by H influenzae type b. The majority of these children had normal serum concentrations of total immunoglobulins, IgG2, hemolytic complement, and antibody to tetanus toxoid (a T-cell-dependent antigen).

Haemophilus influenzae Type b Conjugate Vaccines: Immunization of Children at 15 Months of Age

PEDIATRICS ◽  
1990 ◽  
Vol 86 (5) ◽  
pp. 794-796
Author(s):  
Keyword(s):  
United States ◽  
Haemophilus Influenzae ◽  
Conjugate Vaccine ◽  
Outer Membrane Proteins ◽  
The United States ◽  
Haemophilus Influenzae Type ◽  
Invasive Infection ◽  
Haemophilus Influenzae Type B ◽  
Type B ◽  
Conjugate Vaccines

This statement updates previous information and recommendations regarding Haemophilus influenzae type b conjugate vaccines. The four vaccines that have received extensive clinical investigation and/or licensure by the United States Food and Drug Administration (FDA) are listed in the Table. Previously, the Committee recommended that all infants be immunized at 18 months of age with one of the two conjugate vaccines, designated PRP-D and HbOC, that were licensed at that time.1, 2 A third conjugate vaccine, designated PRP-OMP and consisting of the capsular polysaccharide of H influenzae type b complexed with outer membrane proteins of Neisseria meningitidis, was licensed by the FDA in December 1989. Currently, the FDA has approved labeling for PRP-OMP, HbOC, and PRP-D vaccines that states "Administration of Haemophilus b Conjugate Vaccine may be considered for children as young as 15 months of age when it is expected that the child will not return at 18 months for Haemophilus b immunization." After review of the data available on immunogenicity for PRP-D, HbOC, and PRP-OMP administered to children at 15 months of age, the Committee concludes that all children should be immunized at 15 months of age. BACKGROUND Before the introduction of immunization against H influenzae type b, it was estimated that annually approximately 16 000 cases of invasive infection occurred in the United States in children 5 years of age or younger.3 About 26.6% of cases occurred in children 18 months of age or older, and approximately an additional 9.3% occurred in children 15 to 17 months of age.

Haemophilus influenzae Type b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIBTM): Clinical Evaluation

PEDIATRICS ◽  
1990 ◽  
Vol 85 (4) ◽  
pp. 676-681
Author(s):  
Vincent I. Ahonkhai ◽  
Linda J. Lukacs ◽  
Leslie C. Jonas ◽  
Holly Matthews ◽  
Philip P. Vella ◽  
...  
Keyword(s):  
United States ◽  
Haemophilus Influenzae ◽  
Conjugate Vaccine ◽  
Clinical Evaluation ◽  
Control Strategies ◽  
The United States ◽  
Haemophilus Influenzae Type ◽  
Haemophilus Influenzae Type B ◽  
Type B ◽  
Protein Conjugate

Although systemic infections caused by Haemophilus influenzae type b occur worldwide, detailed epidemiologic data are available in but a few countries.1-3 The public health impact of morbidity, mortality, and serious sequelae from disease caused by H influenzae type b has stimulated the search for control strategies. In the United States now, active immunoprophylaxis is largely favored over treatment or prophylaxis with antibiotics. This preference stems from three major observations: that high mortality and morbidity persist despite the availability of potent antimicrobial agents, that antibiotic-resistant strains of H influenzae type b have emerged, and that implementation of antimicrobial prophylaxis on a large scale has been unsatisfactory. Moreover, universal vaccination has been projected as offering a higher economic benefit than other control strategies.4 A matter of more proximate importance, however, is the search for H influenzae type b vaccines that will confer protection to all age groups, including infants younger than 18 months of age and subpopulations specifically at risk for invasive disease caused by H influenzae type b. Haemophilus b conjugate vaccine (meningococcal protein conjugate), PedvaxHIBTM (PRP-OMPC), is a conjugate H influenzae type b vaccine developed at Merck Sharp & Dohme Research Laboratories that now is undergoing extensive clinical evaluation to assess its prospects for disease control when first administered in early infancy. This is an interim report of results obtained in studies conducted in diverse locations throughout the United States. METHODS Study protocols were approved by Merck Sharp & Dohme Research Laboratories and the Institutional Review Board of each center. Written informed consent was obtained from the parents of subjects at the time of enrollment into each study.

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