Journal article
Establishment of a New Human Pneumococcal Standard Reference Serum, 007sp
Clinical and vaccine immunology, Vol.18(10), pp.1728-1736
10/2011
DOI: 10.1128/CVI.05252-11
PMCID: PMC3187044
PMID: 21852547
Abstract
Lot 89SF has been the reference standard serum pool used in pneumococcal enzyme-linked immunosorbent assays (ELISAs) since 1990. In 2005, it was estimated that there remained between 2 and 5 years' supply of lot 89SF. Since lot 89SF was the reference standard used in the evaluation of the seven-valent pneumococcal conjugate vaccine Prevnar (PCV7), the link to clinical efficacy would be severed if stocks became completely depleted. Furthermore, demonstration of immune responses comparable to those elicited by PCV7 is a licensure approach used for new pneumococcal conjugate vaccines, so a replacement reference standard was required. A total of 278 volunteers were immunized with the 23-valent unconjugated polysaccharide vaccine Pneumovax II, and a unit of blood was obtained twice within 120 days following immunization. Plasma was prepared, pooled, and confirmed to be free from hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV. The pooled serum was poured at 6 ml per vial into 15,333 vials and lyophilized. Immunological bridging of 007sp to 89SF was used 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 five independent laboratories. Antibody concentrations in 007sp were established relative to the lot 89SF reference preparation using the WHO reference ELISA. Subsequently, 12 existing WHO calibration sera had concentrations reassigned for 13 pneumococcal serotypes using new serum 007sp as the reference, and these were compared to concentrations relative to the original reference serum. Agreement was excellent for the 12 WHO calibration sera. The 007sp preparation has replaced 89SF as the pneumococcal reference standard. Sufficient quantity of this new preparation is available such that, with judicious use, it should be available for at least 25 years.
Details
- Title: Subtitle
- Establishment of a New Human Pneumococcal Standard Reference Serum, 007sp
- Creators
- D Goldblatt - University College London Institute of Child Health, London, United KingdomB. D Plikaytis - Centers for Disease Control and Prevention, Atlanta, GeorgiaM Akkoyunlu - FDA/CBER, Bethesda, MarylandJ Antonello - Merck, Sharp & Dohme Corp., West Point, PennsylvaniaL Ashton - University College London Institute of Child Health, London, United KingdomM Blake - FDA/CBER, Bethesda, MarylandR Burton - University of Alabama, Huntsville, AlabamaR Care - National Institute for Biological Standards and Control, Potters Bar, United KingdomN Durant - GlaxoSmithKline Biologicals, Rixensart, BelgiumI Feavers - National Institute for Biological Standards and Control, Potters Bar, United KingdomF Fievet - GlaxoSmithKline Biologicals, Rixensart, BelgiumP Fernsten - Pfizer Vaccine Research, Pearl River, New YorkP Giardina - Pfizer Vaccine Research, Pearl River, New YorkK Jansen - Pfizer Vaccine Research, Pearl River, New YorkL Katz - Mississippi Valley Regional Blood Center, Davenport, IowaL Kierstead - PPD Vaccines & Biologics Laboratory, Wayne, PennsylvaniaL Lee - FDA/CBER, Bethesda, MarylandJ Lin - University of Alabama in HuntsvilleJ Maisonneuve - PATH, Seattle, WashingtonM. H Nahm - University of Alabama in HuntsvilleJ Raab - PPD Vaccines & Biologics Laboratory, Wayne, PennsylvaniaS Romero-Steiner - Centers for Disease Control and Prevention, Atlanta, GeorgiaC Rose - Centers for Disease Control and Prevention, Atlanta, GeorgiaD Schmidt - Centers for Disease Control and Prevention, Atlanta, GeorgiaJ Stapleton - University of Iowa, Iowa City, IowaG. M Carlone - Centers for Disease Control and Prevention, Atlanta, Georgia
- Resource Type
- Journal article
- Publication Details
- Clinical and vaccine immunology, Vol.18(10), pp.1728-1736
- Publisher
- American Society for Microbiology
- DOI
- 10.1128/CVI.05252-11
- PMID
- 21852547
- PMCID
- PMC3187044
- ISSN
- 1556-6811
- eISSN
- 1556-679X
- Language
- English
- Date published
- 10/2011
- Academic Unit
- Microbiology and Immunology; Infectious Diseases; Internal Medicine
- Record Identifier
- 9984094506802771
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