Safety, Tolerability and Immunogenicity of 15-valent Pneumococcal Conjugate Vaccine in Toddlers Previously Vaccinated With 7-valent Pneumococcal Conjugate Vaccine

Meulen, Ajoke Sobanjo-ter; Vesikari, Timo; Malacaman, Edgardo A.; Shapiro, Steven A.; Dallas, Michael J.; Hoover, Patricia A.; McFetridge, Richard; Stek, Jon E.; Marchese, Rocio D.; Hartzel, Jonathan; Watson, Wendy; Musey, Luwy

doi:10.1097/inf.0000000000000516

Cited by 53 publications

(30 citation statements)

References 31 publications

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“…79 Our included studies summarized in the current analysis confirmed that serotype 14 was the most common serotype in African children. 80 The two vaccines provided coverage for 66.9% % and 80.6% of serotypes detected in IPD, respectively The proposed PCV15, which adds serotypes 22F and 33F, 81 would provide coverage against only an additional 0.11% of circulating strains compared with PCV13. Surprisingly, PCV13 was found to cover a higher proportion (98.6%) of serotypes causing nonbacteremic pneumonia/noninvasive disease, compared to IPD (80.6%).…”

Section: Discussionmentioning

confidence: 99%

Childhood pneumococcal disease in Africa – A systematic review and meta-analysis of incidence, serotype distribution, and antimicrobial susceptibility

Tam

Thielen

Obaro

et al. 2017

Vaccine

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Background Determining the incidence, disease-associated serotypes and antimicrobial susceptibility of invasive pneumococcal disease (IPD) among children in Africa is essential in order to monitor the impact of these infections prior to widespread introduction of the pneumococcal conjugate vaccine (PCV). Methods To provide updated estimates of the incidence, serotype distribution, and antimicrobial susceptibility profile of Streptococcus pneumoniae causing disease in Africa, we performed a systematic review of articles published from 2000–2015 using Ovid Medline and Embase. We included prospective and surveillance studies that applied predefined diagnostic criteria. Meta-analysis for all pooled analyses was based on random-effects models. Results We included 38 studies consisting of 386,880 participants in 21 countries over a total of 350,613 person-years. The pooled incidence of IPD was 62.6 (95% CI 16.9, 226.5) per 100,000 person-years, including meningitis which had a pooled incidence of 24.7 (95% CI 11.9, 51.6) per 100,000 person-years. The pooled prevalence of penicillin susceptibility was 78.1% (95% CI 61.9, 89.2). Cumulatively, PCV10 and PCV13 included 66.9% (95% CI 55.9, 76.7) and 80.6% (95% CI 66.3, 90.5) of IPD serotypes, respectively. Conclusions Our study provides an integrated and robust summary of incidence data, serotype distribution and antimicrobial susceptibility for S. pneumoniae in children ≤5 years of age in Africa prior to widespread introduction of PCV on the continent. The heterogeneity of studies and wide range of incidence rates across the continent indicate that surveillance efforts should be intensified in all regions of Africa to improve the integrity of epidemiologic data, vaccine impact and cost benefit. Although the incidence of IPD in young children in Africa is substantial, currently available conjugate vaccines are estimated to cover the majority of invasive disease-causing pneumococcal serotypes. These data provide a reliable baseline from which to monitor the impact of the broad introduction of PCV.

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Section: Discussionmentioning

confidence: 99%

Childhood pneumococcal disease in Africa – A systematic review and meta-analysis of incidence, serotype distribution, and antimicrobial susceptibility

Tam

Thielen

Obaro

et al. 2017

Vaccine

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“…Five independent laboratories participated in bridging the serotype-specific IgG assignments for 89SF to the new reference standard, 007sp, to establish equivalent reference values for 13 pneumococcal capsular serotypes (1,3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) by using the WHO reference ELISA (3). 007sp has replaced 89SF (which is no longer distributed) and been routinely used in pneumococcal assays globally since 2011.With the ongoing requirement to evaluate Pneumovax II and the ongoing development of additional extended valency conjugate vaccines, it has been imperative to assign values to 007sp for additional serotypes (4,5). This report describes the efforts undertaken to establish the serotype-specific IgG concentrations for 007sp to seven more serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F), to validate its performance as a standard, and to assign values to a set of 12 existing World Health Organization (WHO) quality control (QC) serum samples for the serotypes.…”

mentioning

confidence: 99%

“…With the ongoing requirement to evaluate Pneumovax II and the ongoing development of additional extended valency conjugate vaccines, it has been imperative to assign values to 007sp for additional serotypes (4,5). This report describes the efforts undertaken to establish the serotype-specific IgG concentrations for 007sp to seven more serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F), to validate its performance as a standard, and to assign values to a set of 12 existing World Health Organization (WHO) quality control (QC) serum samples for the serotypes.…”

mentioning

confidence: 99%

“…Lot 89SF was used in serotype-specific ELISAs designed to measure IgG antibody specific for individual pneumococcal capsular polysaccharides. Serotype-specific weight-based values for IgG, IgA, and IgM were originally derived for serotypes 1,3,4,5, 6B, 7F, 9V,14, 18C, 19F, and 23F for lot 89SF by Quataert et al (1). Assignments for the additional serotypes in the 23-valent pneumococcal polysaccharide vaccine were subsequently bridged from the assignments for the original 11 serotypes (2).…”

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confidence: 99%

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Assignment of Weight-Based Antibody Units for Seven Additional Serotypes to a Human Pneumococcal Standard Reference Serum, 007sp

McKeen

Burbidge

McElhiney

et al. 2015

Clin Vaccine Immunol

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The pneumococcal enzyme-linked immunosorbent assay (ELISA) reference standard serum, lot 89SF, has been in use since 1990 and was replaced in 2013 with a new reference standard, 007sp, that is projected to be available for the next 25 years. 007sp was generated under an FDA-approved clinical protocol; 278 adult volunteers were immunized with the 23-valent unconjugated polysaccharide vaccine Pneumovax II, and a unit of blood was obtained twice from each immunized subject within 120 days following immunization. Pooled serum was prepared from the plasma of 262 subjects, filled at 6 ml per vial, and lyophilized. Five independent laboratories participated in bridging the serotype-specific IgG assignments for 89SF to the new reference standard, 007sp, to establish equivalent reference values for 13 pneumococcal capsular serotypes (1,3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) by using the WHO reference ELISA. In a second study involving three laboratories, a similar protocol was used to assign weight-based IgG concentrations in micrograms per ml to 007sp of seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) also present in the 23-valent pneumococcal unconjugated polysaccharide vaccine. In addition, the IgG assignments for a 12-member WHO quality control (QC) serum panel were also extended to cover these seven serotypes. Agreement was excellent, with a concordance correlation coefficient (r c ) of >0.996 when each laboratory was compared to the assigned values for the 12 WHO QC serum samples. There are four remaining pneumococcal serotypes (2, 9N, 17F, and 20) found in Pneumovax II for which IgG assignments exist for 89SF and remain to be bridged. AStreptococcus pneumoniae Human Reference Standard, lot 89SF, greatly facilitated the standardization of enzyme-linked immunosorbent assay (ELISA) methodologies during a critical period when the first pneumococcal polysaccharide conjugate vaccines were being evaluated for licensure. Lot 89SF was used in serotype-specific ELISAs designed to measure IgG antibody specific for individual pneumococcal capsular polysaccharides. Serotype-specific weight-based values for IgG, IgA, and IgM were originally derived for serotypes 1,3,4,5, 6B, 7F, 9V,14, 18C, 19F, and 23F for lot 89SF by Quataert et al. (1). Assignments for the additional serotypes in the 23-valent pneumococcal polysaccharide vaccine were subsequently bridged from the assignments for the original 11 serotypes (2). Because of dwindling supplies of 89SF, a new reference standard, 007sp, was developed and described in 2011 (3). This serum was generated under an FDA-approved clinical protocol in which 278 adult volunteers were immunized with the 23-valent unconjugated polysaccharide vaccine Pneumovax II. A unit of blood was obtained twice from each immunized subject within 120 days following immunization. Pooled serum was prepared from the plasma, filled at 6 ml per vial, and lyophilized. Five independent laboratories participated in bridging the serotype-specific IgG assignments for 89SF to the new reference sta...

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“…6 Serotype 33F is included in a 15-valent conjugate vaccine currently in trial. 9 Both 15B and 33F are included in the 23-valent pneumococcal polysaccharide vaccine but this vaccine is not currently recommended for children without underlying medical conditions and is not intended to replace conjugate vaccines. 10 The large number of pneumococcal serotypes, and the possibility for even lessinvasive serotypes such as 15B to produce invasive disease as in patient 2, also provide support for alternative vaccination strategies that are not serotype-specific.…”

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confidence: 99%

Cerebrovascular Complications of Pediatric Pneumococcal Meningitis in the PCV13 Era

Bernson-Leung

Lehman

2016

Hospital Pediatrics

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A previously healthy, full-term 5-month-old girl presented to the emergency department with a 1-day history of fever to 103°F, emesis, poor feeding, and progressive lethargy. She had recently started day care. The patient had received her routine 2-and 4-month childhood vaccines on schedule, including the 13-valent pneumococcal conjugate vaccine (PCV13). Initial examination revealed decreased responsiveness, rightward gaze preference, decreased movement of the left side, and positive Brudzinski sign. Laboratory testing is as in Table 1. Ceftriaxone and vancomycin were started at meningitic dosing. Cerebrospinal fluid grew Streptococcus pneumoniae serotype 33F, a nonvaccine serotype. Case 2A previously healthy 21-month-old boy presented to the emergency department with a 1-day history of fever to 103°F, emesis, cough, and lethargy. Rapid influenza testing was positive for influenza A, and oseltamivir was started. History was notable for day care attendance and multiple sick contacts. He was fully immunized, including PCV13.The next morning, he had a brief seizure with eye deviation and generalized convulsions, and became obtunded. Simultaneously, blood culture grew gram-positive cocci in pairs and chains. He returned to the emergency department, where he had right-sided weakness, posturing, rightward eye deviation, and meningismus as well as further seizures requiring lorazepam and fosphenytoin. Laboratory testing is as in Table 1. Ceftriaxone and vancomycin were started at meningitic dosing. Cerebrospinal fluid grew S pneumoniae serotype 15B, a nonvaccine serotype.

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Safety, Tolerability and Immunogenicity of 15-valent Pneumococcal Conjugate Vaccine in Toddlers Previously Vaccinated With 7-valent Pneumococcal Conjugate Vaccine

Abstract: Both formulations of PCV15 display acceptable safety profiles and induce IgG and OPA responses to all vaccine serotypes.

Cited by 53 publications

References 31 publications

Childhood pneumococcal disease in Africa – A systematic review and meta-analysis of incidence, serotype distribution, and antimicrobial susceptibility

Childhood pneumococcal disease in Africa – A systematic review and meta-analysis of incidence, serotype distribution, and antimicrobial susceptibility

Assignment of Weight-Based Antibody Units for Seven Additional Serotypes to a Human Pneumococcal Standard Reference Serum, 007sp

Cerebrovascular Complications of Pediatric Pneumococcal Meningitis in the PCV13 Era

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