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29 protocols using pneumovax 23

1

Maternal 23vPPV in Pregnancy Outcomes

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This was a secondary analysis of an open label, allocation concealed, outcome-assessor blinded, randomised controlled trial of maternal 23vPPV (PNEUMOVAX® 23, Merck, USA) in pregnancy. The trial was conducted between August 2006 and January 2011. The detailed trial design, eligibility, randomisation procedures (stratified by community of residence) and co-primary outcomes (middle ear disease and infant pneumococcal carriage) are described elsewhere [1 (link)]. The original study protocol is available online [14 ].
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2

Pneumococcal Vaccine Induced Immunity in Mice

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A group of mice (four mice per group for the Ab experiment and ten mice per group for the survival experiment) was intramuscularly administered with 0.125μg of Pneumovax® 23 (Merck, cat#7002681601) in 50μl Ultrapure PBS (Amresco, cat#K812) or PBS alone. Blood was collected, before and after immunization at indicated time. Anti-PPS2 and PPS3 IgM were determined by ELISA. Following reagents were used Pneumococcal polysaccharide Type 3 (PPS3) (ATCC® 31-X, ID # 61810463), Pneumococcal polysaccharide Type 2 (PPS2) (ATCC® 500-X,ID# 63406999), 1× ELISA assay diluent (eBioscience, REF # 00-4202-43) and goat anti-Mouse IgM HRP (cat # 1020-05, SouthernBiotech). One month after the immunization, mice were challenged (i.n) with S. pneumonia (A66.1 strain, serotype 3, ~106 c.f.u in 50μl PBS). Animal health was monitored for eight days.
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3

Pneumococcal Vaccination Sequence Evaluation

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Participants received one dose of PCV13, followed by one dose of PPSV23, with a 2-month interval. PCV13 or Prevenar 13® (Pfizer, New York, NY, USA) includes purified capsular polysaccharide of 13 serotypes of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F) conjugated to a nontoxic variant of diphtheria toxin known as CRM197. PPSV23 or Pneumovax 23® (Merck Sharp & Dohme, Kenilworth, NJ, USA) contains purified capsular polysaccharide of 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). Some participants concomitantly received other recommended vaccinations, such as hepatitis B, influenza, or travel vaccines. All vaccines were administered intramuscularly. Prior to the first vaccination (T0), baseline clinical and demographical data were collected. Serum samples were collected at baseline and at 2, 4, 6, and 12 months after enrollment, and were frozen at −80 °C until further analysis. Serotype-specific pneumococcal IgG serum concentrations were measured using a 26-plex multiplex immunoassay as described previously [16 (link)]. After each vaccination, participants were asked to record adverse events (AEs) through an online questionnaire. Serious adverse events (SAEs) were recorded throughout the study period.
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4

Plasma Immune Response Profiling After Vaccination

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Serum lambda and kappa levels were measured from plasma obtained from two cohorts. The first cohort (Cohort 1) consisted of plasma samples from healthy donors from the Oklahoma Immune Cohort [19 (link)]. This cohort is well characterized for autoantibodies and all donors chosen for this study were autoantibody negative. The second cohort (Cohort 2) was plasma samples from healthy individuals obtained 6 weeks following vaccination with the 2008–2009 influenza vaccine (A/Brisbane/59/2007 (H1N1)-like virus, A/Brisbane/10/2007 (H3N2)-like virus and B/Florida/4/2006-like virus). All protocols were approved by the OMRF Institutional Review Board, and patients consented to participate.
Human monoclonal antibodies were prepared from one donor previously described (PVAX4, [20 (link)]), as well as two new donors PVAX5 and PVAX6. These donors received Pneumovax23 (Merck, Whitehouse Station, NJ) as standard of care vaccination based upon their age or diagnosis of systemic lupus erythematosus (SLE). Donor PVAX5 was a Caucasian male, age 63 with no known autoimmune disease. Donors PVAX4 and PVAX6 were Caucasian females with SLE, ages 45 and 38 respectively. Blood was drawn (~50ml) into ACD vacutainers (BD, Franklin Lakes, NJ) by venipuncture seven days post vaccination and was stored no longer than 18 hours before processing.
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5

Pneumococcal Vaccine Formulations: PCV13 and PPSV23

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The final marketed vaccine formulation of PCV13 contains capsular polysaccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F individually conjugated to nontoxic diphtheria CRM197 carrier protein and adsorbed on AlPO4 (0.125 mg aluminum). Each 0.5-mL dose contains 2.2 µg of polysaccharides of each serotype, except for serotype 6B polysaccharides, which contain 4.4 µg. Excipients include sodium chloride, succinic acid, polysorbate 80, and water for injection. PCV13 formulations used in study A (South Africa) with and without AlPO4 did not contain polysorbate 80.7 (link)
PPSV23 (Pneumovax® 23; Merck & Co., Inc., Whitehouse Station, NJ) contains capsular polysaccharides from serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F. Each 0.5-mL dose contains 25 µg of each polysaccharide type. Excipients include 0.25% phenol as a preservative, sodium chloride, and water.
Study vaccine was administered into the deltoid muscle.
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6

Pneumococcal Vaccine Study in Older Adults

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Volunteers 50–65 years old were recruited between April 2012 and January 2015 in this University of Toledo Institutional Review Board-approved study. Written, informed consent was obtained from all subjects. Exclusion criteria included: active infection (except HIV), PPV <5 years prior, pregnancy, immunosuppressive medications, and prior history of splenectomy or other immunocompromising conditions as defined by ACIP vaccination recommendations [10 (link)]. Volunteers were questioned about any past hospitalizations. Eligibility criteria for HIV+ participants were further defined as current CD4>200, HIV viral load ≤400 copies/ml, and ART for ≥1 year. HIV– controls received a single dose of PCV (Prevnar 13®; Wyeth Pharmaceuticals, Inc.) at enrollment followed by one dose of PPV (Pneumovax 23®; Merck & Co., Inc.) 8 weeks later (PCV/PPV). HIV+ individuals received either PCV/PPV or a single dose of PPV.
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7

Comparative Evaluation of Pneumococcal Vaccines

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V114 is a 15-valent PCV containing capsular polysaccharide from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 23F, 22F, and 33F, all conjugated to CRM197 carrier protein and adjuvanted with 125 μg aluminum phosphate. PCV13 (Prevnar 13; Wyeth LLC, marketed by Pfizer, New York, New York, USA) is a 13-valent PCV containing capsular polysaccharide from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, all conjugated to CRM197 carrier protein and adjuvanted with 125 μg aluminum phosphate. PPSV23 (PNEUMOVAX23; Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, USA) is an unadjuvanted 23-valent pneumococcal polysaccharide vaccine. Each dose contains 25 μg of pneumococcal capsular polysaccharide from serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.
V114 and PCV13 were supplied as sterile suspensions and PPSV23 was supplied as a sterile solution. All vaccines were supplied in prefilled syringes and stored at 2–8°C. They were all administered intramuscularly as 0.5 ml doses.
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8

Laparoscopic Splenectomy for Refractory ITP

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Thirty six patients were included within the study between May 2009 and June 2012. Of these patients, 34 had medically refractory chronic ITP, one had hereditary spherocytosis, and one had autoimmune hemolytic anemia. Informed consent was obtained prior to the procedure. The patients consisted of 19 women and 17 men with a mean age of 54.5 (range 22-66 years). Preoperative platelet counts were under 50.000/mm3 in all patients (range 1.000-48.500). Pneumococcus (Pneumovax 23, Merck & Co Inc., Whitehouse Station, NJ, USA) and Haemophilus influenza type B (Hiberix, GlaxoSmithKline) vaccines were administered two weeks before the operations. The risk of operative bleeding was reduced with IV prednisolone (1 mg/kg) and intravenous IgG (1 g/kg) medication. TUMP-LS was performed in 19 patients and standard LS in 17 patients by the same surgeon. Two groups of patients were compared retrospectively by means of operation time, intra- and postoperative blood loss, perioperative complications, packed red cell and platelet requirements, length of hospitalization, visual analog scale (VAS) pain scores and patient satisfaction (Likert Scale). Umbilical incisions and blood tests of patients were checked on postoperative day 10, 1st , 3rd , and 6th month. Additionally, ultrasonography (USG) was performed in sixth month and first year of follow-up to assess if there was any incisional hernia.
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9

Immunization and Infection Protocols

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Mice were i.v. or i.p. immunized with 5 µg TNP-Ficoll, 5 µg TNP-LPS (LGC Biosearch Technologies), 2.87 µg Pneumovax 23 (Merck), or 50 µg NP-OVA supplemented with alum (LGC Biosearch Technologies). Mice were also i.v. infected with 2 × 107 SP (CPS-14) or i.n. infected with 100 PFU mouse-adapted human influenza virus A/PR/8/34 (PR8). In some experiments, SP was treated with mitomycin to inhibit bacterial proliferation. Lung tissue was processed to determine viral titers by plaque-forming assays.
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10

Immunization Protocols for Antibody Responses

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Mice were immunized i.p. or i.v. with 100 μg/mouse NP-50-ficoll, which is presumed to be the peak amount of antigen, above which an inhibition of the IgM response may occur (Dintzis et al., 1989 (link)). Other antigens were used at the following concentrations: 100 μg/mouse NP-33-KLH with Imject alum (Thermo Fisher), 50 μg/mouse NP-0.15-LPS, 10 μg/mouse NP-18-ficoll for ELISpot experiments (Biosearch Technologies), and 10 μg/mouse Pneumovax 23 (Merck) in PBS. Imject alum was from Thermo Scientific. Blood samples were collected from the tail at days 0, 7, 14, 21, and 28 after immunization.
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