Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults

McFetridge, Richard; Meulen, Ajoke Sobanjo-ter; Folkerth, Steven; Hoekstra, J.; Dallas, Michael J.; Hoover, Patricia A.; Marchese, Rocio D.; Zacholski, Donna M.; Watson, Wendy; Stek, Jon E.; Hartzel, Jonathan; Musey, Luwy

doi:10.1016/j.vaccine.2015.04.025

Cited by 57 publications

(33 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In comparison to the 23-valent pure PS vaccine the conjugate vaccines only include a selection of serotypes reaching 13 PS in total and with the prospect of a 15-valent version [51]. Composition of PCV7 and PCV13 were based on the serotype prevalence in the Western world; a fact that is reflected by the poor coverage in East and Southeast Asia e.g., 60% of the infective serotypes in China [52].…”

Section: Protein Conjugate Vaccinesmentioning

confidence: 99%

From Immunologically Archaic to Neoteric Glycovaccines

Cavallari

Libero

2017

Vaccines

View full text Add to dashboard Cite

Polysaccharides (PS) are present in the outermost surface of bacteria and readily come in contact with immune cells. They interact with specific antibodies, which in turn confer protection from infections. Vaccines with PS from pneumococci, meningococci, Haemophilus influenzae type b, and Salmonella typhi may be protective, although with the important constraint of failing to generate permanent immunological memory. This limitation has in part been circumvented by conjugating glycovaccines to proteins that stimulate T helper cells and facilitate the establishment of immunological memory. Currently, protection evoked by conjugated PS vaccines lasts for a few years. The same approach failed with PS from staphylococci, Streptococcus agalactiae, and Klebsiella. All those germs cause severe infections in humans and often develop resistance to antibiotic therapy. Thereby, prevention is of increasing importance to better control outbreaks. As only 23 of more than 90 pneumococcal serotypes and 4 of 13 clinically relevant Neisseria meningitidis serogroups are covered by available vaccines there is still tremendous clinical need for PS vaccines. This review focuses on glycovaccines and the immunological mechanisms for their success or failure. We discuss recent advances that may facilitate generation of high affinity anti-PS antibodies and confer specific immunity and long-lasting protection.

show abstract

Section: Protein Conjugate Vaccinesmentioning

confidence: 99%

From Immunologically Archaic to Neoteric Glycovaccines

Cavallari

Libero

2017

Vaccines

View full text Add to dashboard Cite

show abstract

“…7,8 Further vaccines are underway expanding the coverage further with the PCV-15 as the most recent example. 9 The 15-valent PCV vaccine, containing the PCV-13 serotypes plus serotypes 22F and 33F, 9 is being tested in clinical trials in the USA. In general, the focus for these vaccines has been children less than 5 y of age; not until recent years, the focus has changed to also include the rest of the population and in particular the elderly.…”

Section: Pneumococcal Conjugate Vaccines (Pcv)mentioning

confidence: 99%

Other age groups than children need to be considered as carriers of Streptococcal pneumoniae serotypes

Slotved

2016

Human Vaccines & Immunotherapeutics

View full text Add to dashboard Cite

We need to raise the issue that focus on children as the only carriage group for pneumococci is not optimal; we need to consider that other age groups might also be carriers of pneumococcal serotypes causing invasive pneumococcal diseases (IPD) in unvaccinated age groups. The pneumococcal conjugate vaccines (PCV) have successfully removed IPD from vaccinated children. Studies have shown an effect of PCV reducing the pneumococcal carriage of PCV serotypes in children. The status for several countries having used PCV for many years is that they do not see PCV serotypes neither carried nor as a cause of IPD in children.PCV vaccination of children has shown a herd protection effect in unvaccinated groups as a reduction in IPD cases caused by PCV serotypes. However, not all PCV serotypes have disappeared as the cause of IPD in the unvaccinated age groups. The author therefore believes that if we are to see PCV serotypes disappear as a cause of IPD in unvaccinated age groups, we need to perform further carriage studies to examine carriage in other age groups. Alternatively, all age groups should be vaccinated against pneumococci to eliminate IPD caused by PCV serotypes from possible hidden carriers.

show abstract

“…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%

“…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).…”

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%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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...

show abstract

Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults

Cited by 57 publications

References 38 publications

From Immunologically Archaic to Neoteric Glycovaccines

From Immunologically Archaic to Neoteric Glycovaccines

Other age groups than children need to be considered as carriers of Streptococcal pneumoniae serotypes

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

Contact Info

Product

Resources

About