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Pcv13

Manufactured by Pfizer

PCV13 is a pneumococcal conjugate vaccine developed by Pfizer. It is designed to protect against 13 strains of the Streptococcus pneumoniae bacteria. The vaccine works by stimulating the body's immune system to produce antibodies that can recognize and fight these bacteria.

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8 protocols using pcv13

1

Pneumococcal Vaccination in Botswana

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Botswana is a landlocked country in southern Africa with a semi-arid climate and a short rainy season that typically occurs from November to March. The country’s under-five child mortality rate was estimated to be 41.6 per 1,000 live births in 2019 [18 ]. Gaborone, the capital and largest city in Botswana, is located in the country’s South-East district and was estimated to have a population of 231,626 in 2011 [19 ]. In July 2012, 13-valent pneumococcal conjugate vaccine (Prevnar 13®, Pfizer; PCV-13) was included in the national immunization program as a 3-dose primary series without a booster (3+0 schedule) with doses administered at 2, 3, and 4 months of age. There was no national program for vaccination of adults or pregnant women against pneumococcus during the study period. The HIV prevalence among individuals 15 to 49 years of age in Botswana was 20.7% in 2019 [20 ]. More than 95% of pregnant women with HIV in Botswana receive antiretroviral therapy, and the vertical HIV transmission rate is estimated to be less than 2% [20 ].
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2

Pneumococcal Vaccine Immune Response

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Eleven healthy volunteers were recruited upon informed and written consent. Two subjects had previously been vaccinated with pneumococcal vaccines (Table 2). Eight subjects received a single dose of a 13-valent conjugate pneumococcal vaccine (Prevenar 13, PCV13, Pfizer) and three subjects received a single dose of a 23-valent unconjugated pneumococcal polysaccharide vaccine (Pneumovax 23, PPV23, MSD). Serum and blood from venous blood were taken before, 2 weeks and 2 months after vaccination. Pneumococcal serotype-specific IgG concentrations were analyzed as described above. Opsonophagocytic killing was assessed using the hirudin assays described above inoculated with a bacterial dilution containing 7.3 ± 3.1 x 103 CFU/mL.
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3

Pneumococcal Vaccine Immune Response Study

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To study cellular and humoral immune responses towards a pneumococcal vaccine, SLy2‐wild‐type (Wt) and Ko littermates were immunized with either 1 µg P23 (SanofiPasteurMSD) or 3 µg PCV13 (Pfizer) in 100 µl PBS intraperitoneally (ip). Complementarily, mice were immunized with 2 µg trinitrophenyl hapten (TNP)–lipopolysaccharide (LPS) in 200 µl PBS. For P23 and LPS, blood was collected before and 4, 7, 14, and 21 days after immunization (retrobulbar blood sampling). For PCV13 studies, mice were killed before and 7, 14, and 21 days after immunization to collect blood, peritoneal cells, spleen, and BM.
All blood samples were collected in Microtainer® blood collection tubes (BD Bioscience). After at least 30 min of incubation at room temperature (RT), tubes were centrifuged at 15,000g for 90 s to collect the serum in the supernatant. Sera were stored at −20°C. Peritoneal lavage (PL) was performed with 5 ml of ice‐cold PBS. Femurs were flushed out with 5 ml of ice‐cold PBS to harvest BM cells. After one washing step, PL and BM cells were directly used for further analysis. Spleens were homogenized using a 70 µm cell strainer and subsequently incubated with erythrocyte lysis buffer to get rid of red blood cells before analysis.
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4

Vaccine-induced Antibody Response in Mice

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Adult female C57/Bl6 mice housed as above, were vaccinated intrapareteneally with 1:50 human dose (10μL vaccine+90μL PBS) PCV-13 (Pfizer) or 10μg recombinant protein: rCppA, or rPiaA, (prepared as described below) conjugated to 130μg alum, or 130μg Alum in a volume of 100μL PBS two weeks prior to mating and then boosted every two weeks for the duration of the study. Pups were infected with wild type BHN97 and monitored as above. For analysis of circulating antibody response by western and ELISA, two additional adult male mice were vaccinated with each antigen and boosted twice. One week following the final boost the mice were anesthetized with 4% isoflorane and bleed by retro-orbital route and maximum blood volume was collected. Mice were then euthanized by CO2 asphyxiation followed by cervical dislocation.
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5

Cost-Effectiveness Analysis of PCV13 and PCV15

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Our analysis was performed from the societal perspective, including both medical and nonmedical costs. Medical costs were from MarketScan data [35 ] while nonmedical costs were informed from Ray et al. [36 (link)] and a Morbidity and Mortality Weekly Report [37 (link)]. For medical costs, conversions to 2021 dollars were done using the Consumer Price Index for medical care. For nonmedical costs, conversions to 2021 dollars were done using the Consumer Price Index for all items [38 ]. All outcomes were discounted by 3% annually. The public ($150.83) and private ($226.43) prices of a dose of PCV13 were obtained from CDC’s 2021 vaccine price list [39 ] and were weighted by public (61%) and private (39%) purchase shares from Pfizer’s (manufacturer of PCV13) internal sales data for 2021 (obtained through email communication). We assumed a vaccine administration cost of $15.04 [40 (link)] and travel/caregiver time cost as $33.30 [41 (link)]. At the time of this analysis, PCV15 (manufactured by Merck) did not have a published price for use within the pediatric population. Based on the price of PCV15 use among adults and following discussions Merck, we assumed the private price for PCV15 was $216.09 and the public price was $150.83.
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6

Cost-Effectiveness Analysis of PCV13 and PCV15

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Our analysis was performed from the societal perspective, including both medical and nonmedical costs. Medical costs were from MarketScan data [35 ] while nonmedical costs were informed from Ray et al. [36 (link)] and a Morbidity and Mortality Weekly Report [37 (link)]. For medical costs, conversions to 2021 dollars were done using the Consumer Price Index for medical care. For nonmedical costs, conversions to 2021 dollars were done using the Consumer Price Index for all items [38 ]. All outcomes were discounted by 3% annually. The public ($150.83) and private ($226.43) prices of a dose of PCV13 were obtained from CDC’s 2021 vaccine price list [39 ] and were weighted by public (61%) and private (39%) purchase shares from Pfizer’s (manufacturer of PCV13) internal sales data for 2021 (obtained through email communication). We assumed a vaccine administration cost of $15.04 [40 (link)] and travel/caregiver time cost as $33.30 [41 (link)]. At the time of this analysis, PCV15 (manufactured by Merck) did not have a published price for use within the pediatric population. Based on the price of PCV15 use among adults and following discussions Merck, we assumed the private price for PCV15 was $216.09 and the public price was $150.83.
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7

Pneumococcal and Influenza Vaccine Protocols

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PCV13 (lot #H32094, Pfizer Inc) contains polysaccharides from pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F individually conjugated to nontoxic diphtheria toxin cross-reactive material 197 (CRM197). Each 0.5-mL dose contains 2.2 µg of each polysaccharide, except for 4.4 µg for 6B, 5 mM succinate buffer, 0.85% sodium chloride, 0.02% polysorbate 80, and 0.125 mg aluminum as aluminum phosphate. Placebo (lot #J13932) matched the PCV13 formulation for aluminum phosphate, succinate buffer, sodium chloride, and polysorbate 80. QIV (Fluzone Quadrivalent; lot #UI158AA) was manufactured by Sanofi Pasteur MSD (Swiftwater, PA, USA) and contained hemagglutinin antigens from 4 influenza strains: 2 A strains(A/H1N1/California/7/2009 and A/H3N2/Texas/50/2012) and 2 B strains (B/Brisbane/60/2008 and B/Massachusetts/2/2012).
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8

Pneumococcal Conjugate and Polysaccharide Vaccines

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PCV13 (Pfizer), 0.5 mL, contains polysaccharides of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; each one is individually conjugated to CRM197 (non-toxic mutant of diphtheria toxin). The vaccine contains 4.4 µg of 6B and 2.2 µg of each remaining saccharide. PPV23 (Sanofi Pasteur), 0.5 mL, consists of purified capsular polysaccharide. PPV23 contains 25 µg of each pneumococcal serotype: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Vaccines were administered intramuscularly.
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