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Prevnar

Manufactured by Pfizer
Sourced in United States, Belgium

Prevnar is a laboratory product designed for the detection and quantification of pneumococcal antibodies. It serves as a tool for researchers and scientists to measure immune response to pneumococcal vaccines.

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8 protocols using prevnar

1

Pneumococcal Vaccination Responses in AAV Patients

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At 6 months, 36 of 38 AAV patients (18 treated/18 controls) were vaccinated with a T-cell–dependent PCV13 (0.5 mL; Prevnar, Pfizer) as per clinical recommendations [21 (link)]. Participants had not received pneumococcal vaccination in the preceding 5 years. Blood was drawn prior to vaccination and 4 weeks postvaccination to determine serotype-specific anti-IgG titer for 12 pneumococcal serotypes contained in PCV13 (serotypes 1, 3, 4, 5, 6b, 7f, 9v, 14, 18c, 19a, 19f, 23f) using a multiplex assay quality assured externally by the United Kingdom National External Quality Assessment Service [22 (link)]. Serum was separated from blood by centrifugation and cryopreserved at –80°C until analysis. Because a protective level of serum antibody has not been strictly defined and may differ among serotypes, we used the antibody response ratio (ARR) as a measure of immune response to vaccination as previously employed by others [23 (link)]. ARR was calculated (antibody titer at 4 weeks postvaccination / antibody titer prior to vaccination), and mean ARR (sum of ARR in all serotypes assessed / number of serotypes) was utilized as a single measure of immune response.
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2

Reanalysis of Pneumococcal Vaccine Trials

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A total of 1,574 archived serum samples were selected from 13vPnC and 7vPnC clinical trials conducted in infants and toddlers for reanalysis by the dLIA method based on the remaining sample volume and the serotype-specific IgG concentration by the WHO reference ELISA. Serum samples from four completed trials from the United States, Germany, and Japan were included (12 (link), 14 (link), 15 (link), 19 (link)). Clinical studies 6096A1-006 and 6096A1-3024 were phase 3 noninferiority trials conducted in Germany and Japan, respectively (14 (link), 19 (link)). Clinical study 6096A1-3005 was a phase 3 lot consistency trial conducted in the United States (15 (link)). These three trials supported Prevnar 13 (Pfizer, Inc.) registrations for infants. Serum samples from the post-primary-series immunization population and from the postbooster population were arranged into defined serum panels, as shown in Table 4. Note that preimmunization sera were not collected in these clinical trials. Therefore, paired pre- and postimmunization samples were obtained from study 6096A1-003, an early phase 1/2 trial in the United States, in which serum was collected prior to the first vaccine dose and again 1 month after the third immunization (see Table 4) (12 (link)).
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3

Longitudinal Evaluation of Pneumococcal and NTHi Immunity

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This study derives from a 5-year (2006-2011) prospective longitudinal evaluation of immunity to Spn and NTHi NP colonization and AOM in young children ages 6 to 24 months, supported by the U.S. National Institute of Deafness and Communication Disorders. Healthy children without previous episodes of AOM were enrolled at 6 months of age from a middle class, suburban sociodemographic pediatric practice in Rochester, NY (Legacy Pediatrics). NP samples were obtained every 3 to 6 months prospectively from healthy children at 6-24 months of age. When AOM occurred tympanocentesis was performed to collect MEF and confirm the diagnosis of AOM, as previously described.28 (link) At the time of an AOM diagnosis NP and MEF samples were concurrently obtained. All children in this study who developed an AOM had common clinical symptoms of viral upper respiratory infection (URI) such as cough, sore throat, runny nose, nasal congestion, headache, low grade fever and sneezing. All of the children received standard vaccinations including the PCV-7 or PCV-13 pneumococcal conjugate vaccine (Prevnar, Pfizer Pharmaceuticals, Collegeville, PA) at the appropriate age. The study was approved by the Institutional Review Board (IRB) of the University of Rochester and Rochester General Hospital, and written informed consent was obtained from parents or guardians of all child subjects.
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4

Longitudinal Evaluation of Pneumococcal and NTHi Immunity

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This study derives from a 5-year (2006-2011) prospective longitudinal evaluation of immunity to Spn and NTHi NP colonization and AOM in young children ages 6 to 24 months, supported by the U.S. National Institute of Deafness and Communication Disorders. Healthy children without previous episodes of AOM were enrolled at 6 months of age from a middle class, suburban sociodemographic pediatric practice in Rochester, NY (Legacy Pediatrics). NP samples were obtained every 3 to 6 months prospectively from healthy children at 6-24 months of age. When AOM occurred tympanocentesis was performed to collect MEF and confirm the diagnosis of AOM, as previously described.28 (link) At the time of an AOM diagnosis NP and MEF samples were concurrently obtained. All children in this study who developed an AOM had common clinical symptoms of viral upper respiratory infection (URI) such as cough, sore throat, runny nose, nasal congestion, headache, low grade fever and sneezing. All of the children received standard vaccinations including the PCV-7 or PCV-13 pneumococcal conjugate vaccine (Prevnar, Pfizer Pharmaceuticals, Collegeville, PA) at the appropriate age. The study was approved by the Institutional Review Board (IRB) of the University of Rochester and Rochester General Hospital, and written informed consent was obtained from parents or guardians of all child subjects.
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5

Fiji Pneumococcal Vaccine Study Follow-up

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The study design and details of the Fiji Pneumococcal Project (FiPP, 2003-2008) have been reported previously10 (link)-12 (link). Briefly, healthy Fijian infants (N=552) were randomised to receive a primary series of 0, 1, 2 or 3 doses of the 7-valent pneumococcal conjugate vaccine (PCV7, Prevnar®, Pfizer Inc.), with half the children randomised to receive the 23-valent pneumococcal polysaccharide vaccine (23vPPV, Pneumovax®, Merck & Co., Inc., USA) at 12 months of age. Children given 0 or 1 PCV7 during the primary series were given a catch-up PCV7 dose at 2 years of age (Table I). Between March 2011 and February 2012, families who had participated in FiPP and who had previously agreed to be contacted for follow-up studies, were invited to participate in a follow-up study. Following consent, on the first visit, all children had 10 mL of blood drawn into a sodium heparin tube, and a nasopharyngeal (NP) swab was taken according to standard methods13 (link). In addition, they were each administered a single dose of PCV13. A second blood sample was taken 28 days later. This study was approved by the Fiji National Research Ethics Review Committee and the Royal Children's Hospital Human Research Ethics Committee in Melbourne, Australia.
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6

Pentavalent and Hexavalent Vaccine Comparison

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Pentavalent vaccine (DTwP-HBV-Hib; Eupenta, LG Chem; Seoul, South Korea) and hexavalent vaccine (DTaP-IPV-HBV-Hib; Infanrix-Hexa, GlaxoSmithKline, Mississauga, Canada) were used in this study. According to the group assigned, the participants received 0.5 ml of the vaccines intramuscularly at 2, 4 and 6 months of age. The components of each vaccine are listed in Table, Supplemental Digital Content 1, https://links.lww.com/INF/F600. Concomitant pneumococcal conjugated vaccination (either with Prevnar, Pfizer, Bruxelles, Belgium or Synflorix, GlaxoSmithKline; Ontario, Canada) at 2-, 4-and 6-month-old and administration of seasonal influenza vaccine were at the discretion of parents.
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7

PCV-13 Immunization and Pneumococcal Colonization

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The PCV/EHPC study was conducted in 2012 and detailed methods for recruitment, nasopharyngeal pneumococcal inoculation and carriage detection as well as study design and study outcomes have been previously described.9 Ethical approval was obtained from the National Health Service (NHS) Research Ethics Committee (REC) (12/NW/0873). This study was co-sponsored by the Royal Liverpool and Broadgreen University Hospitals Trust and the Liverpool School of Tropical Medicine.
Briefly, 96 healthy adults aged 18–50 years were enrolled with informed consent and randomised to receive a single dose of either PCV-13 (Prevnar, Pfizer) or Hep-A vaccine as a control group (Avaxim, Sanofi Pasteur MSD). 4-5 weeks following vaccination subjects were intra-nasally inoculated with live 6B pneumococcus (BHN418) (80,000 CFUs per nostril).24 Sera samples were collected before vaccination (Pre-V), after vaccination/prior to pneumococcal inoculation (Post-V) and 21 days after pneumococcal inoculation. Nasal wash (NW) samples were collected at the same time points and also at days 2, 7 and 14 following pneumococcal inoculation (Supplementary Fig 1).
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8

PCV-13 Immunization and Pneumococcal Colonization

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The PCV/EHPC study was conducted in 2012 and detailed methods for recruitment, nasopharyngeal pneumococcal inoculation and carriage detection as well as study design and study outcomes have been previously described.9 Ethical approval was obtained from the National Health Service (NHS) Research Ethics Committee (REC) (12/NW/0873). This study was co-sponsored by the Royal Liverpool and Broadgreen University Hospitals Trust and the Liverpool School of Tropical Medicine.
Briefly, 96 healthy adults aged 18–50 years were enrolled with informed consent and randomised to receive a single dose of either PCV-13 (Prevnar, Pfizer) or Hep-A vaccine as a control group (Avaxim, Sanofi Pasteur MSD). 4-5 weeks following vaccination subjects were intra-nasally inoculated with live 6B pneumococcus (BHN418) (80,000 CFUs per nostril).24 Sera samples were collected before vaccination (Pre-V), after vaccination/prior to pneumococcal inoculation (Post-V) and 21 days after pneumococcal inoculation. Nasal wash (NW) samples were collected at the same time points and also at days 2, 7 and 14 following pneumococcal inoculation (Supplementary Fig 1).
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