Pneumovax (Pneumococcal Vaccine Polyvalent) - Summary

PNEUMOVAX SUMMARY

PNEUMOVAX * 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in the United States. (See Table 1.) The 23-valent vaccine accounts for at least 90% of pneumococcal blood isolates and at least 85% of all pneumococcal isolates from sites which are generally sterile as determined by ongoing surveillance of U.S. data.

PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine.

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NEWS HIGHLIGHTS

Published Studies Related to Pneumovax (Pneumococcal Vaccine Polyvalent)

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.

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Clinical Trials Related to Pneumovax (Pneumococcal Vaccine Polyvalent)

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.

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.

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.

Study Evaluating Prevenar Vaccine in Healthy Infants [Completed]

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