PREVNAR SUMMARY
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar® , is a sterile solution of saccharides of the capsular antigens of
Streptococcus pneumoniae
serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F individually conjugated to diphtheria CRM197 protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography.
Prevnar® is indicated for active immunization of infants and toddlers against invasive disease caused by
S. pneumoniae
due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). The routine schedule is 2, 4, 6, and 12-15 months of age.
The decision to administer Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar® should be based primarily on its efficacy in preventing invasive pneumococcal disease. As with any vaccine, Prevnar® may not protect all individuals receiving the vaccine from invasive pneumococcal disease.
Prevnar® is also indicated for active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine. However, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. Additionally, because otitis media is caused by many organisms other than serotypes of
S. pneumoniae
represented in the vaccine, protection against all causes of otitis media is expected to be low.
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NEWS HIGHLIGHTSMedia Articles Related to Prevnar (Pneumococcal Vaccine)
FDA Advisory Committee Finds Data Support The Safety And Effectiveness Of Prevnar 13™ Vaccine For The Prevention Of Invasive Pneumococcal Diseas
Source: Immune System / Vaccines News From Medical News Today [2009.11.19]
Pfizer Inc (NYSE:PFE) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children.
FDA Panel Votes in Favor of New Strep Pneumoniae Vaccine
Source: MedPage Today Infectious Disease [2009.11.18]
BETHESDA, Md. (MedPage Today) -- A Food and Drug Administration (FDA) advisory panel has voted to recommend approval of an updated version of the Streptococcus pneumoniae vaccine Prevnar.
FDA Panel to Vote on Updated Strep pneumoniae Vaccine
Source: MedPage Today Infectious Disease [2009.11.17]
WASHINGTON (MedPage Today) -- A Food and Drug Administration (FDA) advisory panel will decide Wednesday whether to recommend approval of a new version of the popular Streptococcus pneumoniae children's vaccine Prevnar.
Adult Smokers Need Pneumococcal Vaccine
Source: MedicineNet Pneumococcal Vaccination Specialty [2008.10.23]
Title: Adult Smokers Need Pneumococcal Vaccine
Category: Health News
Created: 10/23/2008
Last Editorial Review: 10/23/2008
Published Studies Related to Prevnar (Pneumococcal Vaccine)
Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. [2009.09.15]
RATIONALE: Debate exists about the immunogenicity and protective efficacy of antibodies produced by the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in chronic obstructive pulmonary disease (COPD). The 7-valent diphtheria-conjugated pneumococcal polysaccharide vaccine (PCV7) induces a more robust immune response than PPSV23 in healthy elderly adults. OBJECTIVES: We hypothesized that serotype-specific IgG antibody concentration and functional antibody activity would be superior after PCV7 vaccination compared with PPSV23 in moderate to severe COPD. We also posited that older age and prior PPSV23 vaccination would be associated with reduced vaccine responsiveness... CONCLUSIONS: PCV7 induces a superior immune response at 1 month post vaccination compared with PPSV23 in COPD. Older age and prior PPSV23 reduce vaccine responsiveness. Clinical trial registered with www.clinicaltrials.gov (NCT00457977).
Safety and immunogenicity of sequential pneumococcal immunization in preschool asthmatics. [2009.08.20]
OBJECTIVE: Respiratory infections are major triggers of exacerbations in preschool asthma. Many countries' guidelines recommend immunization against pneumococci for patients suffering from chronic airway disease. Beyond infancy, however, data on the immunogenicity and safety are scarce. Also, the interval between priming and booster is a matter of debate... CONCLUSIONS: Although both sequential pneumococcal vaccine regimens were safe and immunogenic among preschool asthmatics, immunogenicity was higher when the booster was given after 10 months.
Nasopharyngeal carriage of Streptococcus pneumoniae in Navajo and White Mountain Apache children before the introduction of pneumococcal conjugate vaccine. [2009.08]
BACKGROUND: Infants and children are frequently colonized with pneumococcus. Recent nasopharyngeal acquisition of pneumococcus is thought to precede disease episodes. The increased risk of pneumococcal disease among Navajo and White Mountain Apache populations has been documented. Little is known about the dynamics of pneumococcal carriage in these populations... CONCLUSIONS: The high carriage prevalence among Navajo and Apache children reflects an intense exposure to pneumococcus. The lack of modifiable risk factors for carriage highlights the importance of preventive strategies for disease control.
Immunogenicity and reactogenicity of pneumococcal polysaccharide and conjugate vaccines in alaska native adults 55-70 years of age. [2009.07.15]
BACKGROUND: Vaccination with conjugate vaccines stimulates T cell-dependent immunity, whereas vaccination with polysaccharide vaccines does not. Thus, vaccination with the 7-valent pneumococcal conjugate vaccine (PCV7) followed by the 23-valent pneumococcal polysaccharide vaccine (PPV23) may offer better protection against invasive pneumococcal disease for older adults than does vaccination with PPV23 alone, which is what is currently recommended... CONCLUSIONS: In this study, PCV7 given 2 or 6 months before PPV23 was well tolerated but did not improve immune response to PPV23 in older Alaska Native adults.
Effect of reduced-dose schedules with 7-valent pneumococcal conjugate vaccine on nasopharyngeal pneumococcal carriage in children: a randomized controlled trial. [2009.07.08]
CONTEXT: The effects of reduced-dose schedules of 7-valent pneumococcal conjugate vaccine (PCV-7) on pneumococcal carriage in children are largely unknown, although highly relevant in the context of subsequent herd effects. OBJECTIVE: To examine the effects of a 2-dose and 2 + 1-dose PCV-7 schedule on nasopharyngeal pneumococcal carriage in young children compared with controls... CONCLUSION: Compared with no pneumococcal vaccination, a 2 + 1-dose and 2-dose schedule of PCV-7 resulted in significant reductions of vaccine serotype pneumococcal carriage in the second year of life. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00189020.
Clinical Trials Related to Prevnar (Pneumococcal Vaccine)
Immuno-Augmentation With GM-CSF of Pneumococcal Vaccine in Chronic Lymphocytic Leukemia Patients [Active, not recruiting]
Primary Objective:
1. To evaluate efficacy of GM-CSF-mediated enhanced seroconversion (protective
anti-pneumococcal serum immunoglobulins) in patients receiving conventional 23-valent
capsular polysaccharide pneumococcal vaccine (PPV) and 7-valent Pneumococcal conjugated
vaccine (PCV7) while undergoing treatment for advanced chronic lymphocytic leukemia (CLL).
Secondary Objective:
1. To evaluate the effect of GM-CSF on the dendritic cells and cytokine production in CLL
patients.
Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine [Active, not recruiting]
The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination
("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more
effective without causing too many side effects.
Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis [Completed]
Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal
meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality
and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of
dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely
observational manner, we thought to measure blood and CSF concentrations of vancomycin in
adult patients with pneumococcal meningitis, treated with vancomycin, third-generation
cephalosporin and dexamethasone.
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants [Active, not recruiting]
The purpose of the study is to provide immunogenicity and safety data of the investigational
hexavalent vaccine when it is given concomitantly (the same day at separate injection sites)
with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB
vaccine at birth.
Primary Objective:
To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune
response that is at least as good as the response following Infanrix™-Hexa in terms of
seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6
months), when co-administered with Prevnar®
Secondary Objectives:
Immunogenicity:
To describe in each group the immunogenicity parameters to each vaccine component (for
DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.
Safety:
To describe the overall safety after each injection.
Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults. [Completed]
Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients.
The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count
lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal
vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.
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