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16 protocols using pneumovax

1

Pneumococcal Polysaccharide-CRM197 Vaccine

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Example 7

Pneumococcal polysaccharide-CRM197 covalent. Compounds for serotypes containing 1, 3, 5, 7F, 14, 18C, 22F, 23F, 33F, 35B (10 serotypes polysaccharides) and cross-reactive polysaccharide compounds of (6A, 6B), (9V, 9N), (15A, 15B) and (19A, 19F) (8 serotypes) were combined to yield final polysaccharide concentration of 2.2-4.4 μg PS/mL (1.1-2.2 μg/human dose, 0.5 mL). Sodium chloride (150 mM) solution, 10-20 mM histidine, 20 mM HEPES or MOPS buffer and 0.001% Tween-20 was also used during the formulation process as diluent, and aluminum phosphate (Adju-Phos, Brenntag, USA) was used as investigational adjuvant.

18-valent or higher valent (>20V-24V) covalent compound was aseptically filled in 2 mL sterile vials. PNEUMOVAX® (Merck, USA) and/or PREVNAR-13® (Pfizer, USA) were used as controls.

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2

Vaccination Protocols for Inflammatory Bowel Disease

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Influenza vaccination was carried out with the trivalent component vaccine (Afluria, Seqirus USA Inc., King of Prussia, PA) or for patients’ ages 65 years and older (Fluzone, Sanofi Pasteur, Swiftwater, PA). Both of these vaccines were administered in a single dose of 0.5 mL intramuscularly.
Vaccination for pneumococcal pneumonia was carried out with either the PPSV23 (Pneumovax, Merck, Whitehouse Station, NJ) or with the PCV13 (Prevnar 13, Pfizer, Philadelphia, PA). Both vaccines were administered in a single dose of 0.5 mL intramuscularly. The selection of which pneumococcal vaccine was appropriate for the patient to receive was based on ACIP guidelines for these two vaccines.
Vaccination for hepatitis B was carried out with the Energix-B (Glaxo Smith Kline, Research Triangle Park, NC), administered in a three-dose series with 1.0 mL given at 0, 1, and 6 months or for patients receiving a booster, a single intramuscular dose of 1.0 mL was given.
Serum was obtained at the baseline visit prior to vaccination, and subjects returned 2–4 weeks later for follow-up blood collection. At this follow-up visit, subjects again completed the HBI for CD or SCCAI for UC questionnaire and were assessed for adverse events. Patients received a follow-up phone call between the initiation and follow-up visit to assess for adverse events.
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3

Pneumococcal Vaccine Composition Comparison

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23vPPV (Merck Pneumovax) consists of a mixture of purified capsular polysaccharides from 23 serotypes of S. pneumoniae: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F. The vaccine does not contain an adjuvant.
PCV7 (Wyeth/Pfizer Prevenar7), which is currently licensed for pediatric use, contains polysaccharides of pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. The polysaccharides are conjugated to the protein carrier CRM197. The vaccine contains aluminium phosphate as an adjuvant.
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4

Reduced Dose PCV7 Vaccine Impact

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The samples used in this study were collected as part of a phase II single-blind, open label, randomized controlled vaccine trial in Suva, Fiji aimed at examining the impact of reduced dose PCV7 (Prevenar, Pfizer Inc., USA) schedules on the safety, immunogenicity and nasopharyngeal (NP) carriage in 552 infants [19 (link)]. For this study, serum samples and NP swabs were analysed from all infants who received one (n=66), 2 (n=80) or 3 (n=65) PCV7 doses during infancy (at 14 weeks; 6 and 14 weeks, or 6, 10 and 14 weeks, respectively) and all were given PPS vaccine (Pneumovax, Merck, USA) at 12 months of age. The study was approved by the approved by the Fiji National Research Ethics Review Committee and the University of Melbourne Human Research Ethics Committee. All laboratory staff members were blinded to the group allocation for each of the study measurements.
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5

Prime-Boost Pneumococcal Vaccination in HIV

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This study was undertaken in an ambulatory HIV clinic in the Department of Genitourinary Medicine and Infectious Diseases (GUIDE), St James’s Hospital, Dublin, Ireland.
Pneumococcal vaccine naïve HIV-infected individuals >18 years with CD4 cell counts ≥200 cells/mm3 meeting eligibility criteria outlined in the study protocol (EudraCT number 2011-000260-99) were recruited between April 2011 and July 2012. As international pneumococcal vaccine recommendations changed in 2012 to recommend PCV13 followed by PPSV23 for all HIV-infected adults recruitment to this study was discontinued and the prime boost immunisation strategy implemented as standard of care for all patients attending our clinic.
Participants were randomized by computer generated allocation sequence with equal probability of being randomized to PCV13 (Prevnar; Wyeth Pharmaceuticals) at week 0 followed by PPSV23 at week 4 (prime boost group) or PPSV23 alone (Pneumovax; Merck) at week 4 (PPSV23 group). All subjects provided written informed consent.
Vaccines were supplied in pre-filled single-dose syringes without preservatives and stored according to manufacturer guidelines at 2–8 °C. Vaccines were injected intramuscularly (0.5 mL) in the deltoid muscle with the use of a 23-gauge, 1-inch needle.
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6

Pneumococcal Vaccine Response in CVID Patients

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Patients and HD were immunized with 1 dose of Pneumovax® (Merck and Co., Inc., West Point, PA, Lederle Pearl River, NY, USA) a 23-valent polysaccharide vaccine which contains the pneumococcal serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23,F and 33F. Based on our previous study (11 (link)) on the antibody response kinetics, blood samples of CVID patients were collected, aliquoted and stored at −20°C at the day pre-immunization (pre), and at 4 weeks post-immunization (post 1). A third assessment was done at 36 ± 6 months post-immunization (post 2). ELISA test was used to quantify the serotype-specific anti-PnPS IgA responses.
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7

Pneumococcal Vaccine Immunogenicity Analysis

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Three quality control (QC) serum pools were prepared by mixing equal volumes of serum from four healthy young adults (12 total donors, aged 22–34 years) 1 month after vaccination with PPV23 (Pneumovax; Merck & Co., Inc., Whitehouse Station, NJ, USA). The serum pools were expected to have variable opsonic indices (OIs) for each serotype.
A total of 42 serum samples were collected from healthy adults aged 20–50 years. Of these samples, 35 samples were obtained 14 to 27 days after immunization with PPV23 (Prodiax23®; Merck & Co., Inc.) by intramuscular injection (group 1). Seven samples were obtained from subjects immunized previously (46 to 123 months prior) with PPV23 (Prodiax23®) (group 2). OIs for 11 additional non-PCV13 serotypes were studied for 42 serum samples. The accuracy of MOPA was studied using 20 selected sera because of the limited volume for analysis.
Collected samples were stored frozen at −70°C until testing. All serum samples were heat-inactivated at 56°C for 30 minutes to inactivate endogenous complement activity and confirmed as antibiotic-free in test cultures with a rough pneumococcal strain (R36A).
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8

Multivalent Pneumococcal Polysaccharide Conjugate

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Example 7

Pneumococcal polysaccharide-CRM197 covalent. Compounds for serotypes containing 1, 3, 5, 7F, 14, 18C, 22F, 23F, 33F, 35B (10 serotypes polysaccharides) and cross-reactive polysaccharide compounds of (6A, 6B), (9V, 9N), (15A, 15B) and (19A, 19F) (8 serotypes) were combined to yield final polysaccharide concentration of 2.2-4.4 μg PS/mL (1.1-2.2 μg/human dose, 0.5 mL). Sodium chloride (150 mM) solution, 10-20 mM histidine, 20 mM HEPES or MOPS buffer and 0.001% Tween-20 was also used during the formulation process as diluent, and aluminum phosphate (Adju-Phos, Brenntag, USA) was used as investigational adjuvant.

18-valent or higher valent (>20V-24V) covalent compound was aseptically filled in 2 mL sterile vials. PNEUMOVAX® (Merck, USA) and/or PREVNAR-13® (Pfizer, USA) were used as controls.

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9

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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10

Influenza and Pneumococcal Vaccination Study

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Five- to six-week-old C57BL/6 and B6.Cg-Lepob/J mice were bled for baseline serum samples, lightly anesthetized with isofluorane, and then vaccinated intramuscularly (n = 5/group) with PBS, 4 hemagglutinating units of β-propriolactone-inactivated, sucrose-purified A/California/04/2009 virus, Pneumovax (Merck), Prevnar (Wyeth), or protein-based YLN vaccine (44 (link)). Prevnar and YLN vaccine were supplemented with alum as an adjuvant. Three weeks following initial vaccination, mice were then boosted with a second dose of vaccine or PBS. Two weeks after the boost, mice were bled for serum collection and then challenged as described above. Serological assessments for influenza virus (42 (link)) and bacterial vaccination (44 (link)) were performed as described previously.
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