Safety and Immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine in 2 to 70 Years Old Healthy People in China
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      Pneumococcal infection is a leading cause of death throughout the world and a major cause of
      pneumonia, bacteremia, meningitis, and otitis media.

      It has been established that purified pneumococcal capsular polysaccharides induce antibody
      production and such antibody is effective in preventing pneumococcal disease. Clinical
      studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in
      polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children of two years old
      and older and in adults of all ages have showed immunogenic response. In order to provide
      more evidence for the immunogenicity and the safety of the vaccine, a phase III clinical
      trial is planed to conduct.
    

Detailed description: 
      Pneumonia is a major cause of morbidity and mortality in developing countries. Pneumonia is
      predominantly bacterial in origin: isolation rates of Streptococcus pneumoniae and
      Haemophilus influenzae were 34% and 40%, respectively, in a series of lung aspirates
      collected from children under 5 years of age (Shann et al., 1984).

      Pneumococcal infection is a leading cause of death throughout the world and a major cause of
      pneumonia, bacteremia, meningitis, and otitis media.

      Strains of drug-resistant S. pneumoniae have become increasingly common in China and in other
      parts of the world. In some areas as many as 35% of pneumococcal isolates have been reported
      to be resistant to penicillin. Many penicillin-resistant pneumococci are also resistant to
      other antimicrobial drugs (e.g., erythromycin, trimethoprim-sulfamethoxazole and
      extended-spectrum cephalosporins), therefore the importance of vaccine prophylaxis should be
      emphasized against pneumococcal disease.

      Epidemiology Pneumococcal infection causes approximately125,000 deaths annually in China. At
      least 2,500,000 cases of pneumococcal pneumonia are estimated to occur annually in the United
      States; S. pneumoniae accounts for approximately 25-35% of cases of community-acquired
      bacterial pneumonia in persons who require hospitalization.

      Despite appropriate antimicrobial therapy and intensive medical care, the overall
      case-fatality rate for pneumococcal bacteremia is 15-20% among adults, and among elderly
      patients this rate is approximately 30-40%. An overall case-fatality rate of 36% was
      documented for adult inner-city residents who were hospitalized for pneumococcal bacteremia.

      Invasive pneumococcal disease (e.g., bacteremia or meningitis) and pneumonia cause high
      morbidity and mortality in spite of effective antimicrobial control by antibiotics. These
      effects of pneumococcal disease appear due to irreversible physiologic damage caused by the
      bacteria during the first 5 days following onset of illness, and occur regardless of
      antimicrobial therapy. Vaccination offers an effective mean of further reducing the mortality
      and morbidity of this disease.

      Risk Factors In addition to the very young and persons 65 years of age or older, patients
      with certain chronic conditions are at increased risk of developing pneumococcal infection
      and severe pneumococcal illness.

      Patients with chronic cardiovascular diseases (e.g., congestive heart failure or
      cardiomyopathy), chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease or
      emphysema), or chronic liver diseases (e.g., cirrhosis), diabetes mellitus, alcoholism or
      asthma (when it occurs with chronic bronchitis, emphysema, or long-term use of systemic
      corticosteroids) have an increased risk of pneumococcal disease. In adults, this population
      is generally immunocompetent.

      Patients at high risk are those who have a decreased responsiveness to polysaccharide antigen
      or an increased rate of decline in serum antibody concentration as a result of:
      immunosuppressive conditions (congenital immunodeficiency, human immunodeficiency virus (HIV)
      infection, leukemia, lymphoma, multiple myeloma, Hodgkin's disease, or generalized
      malignancy); organ or bone marrow transplantation; therapy with alkylating agents,
      antimetabolites, or systemic corticosteroids; chronic renal failure or nephrotic syndrome.

      Patients at the highest risk of pneumococcal infection are those with functional or anatomic
      asplenia (e.g., sickle cell disease or splenectomy), because this condition leads to reduced
      clearance of encapsulated bacteria from the bloodstream. Children who have sickle cell
      disease or have had a splenectomy are at increased risk of outbreak pneumococcal sepsis
      associated with high mortality.

      Immunogenicity It has been established that purified pneumococcal capsular polysaccharides
      induce antibody production and that such antibody is effective in preventing pneumococcal
      disease. Clinical studies have demonstrated the immunogenicity of each of the 23 capsular
      types when tested in polyvalent vaccines.

      Studies of 23-valent pneumococcal vaccines in children of two years old and older and in
      adults of all ages have showed immunogenic responses. Protective capsular type-specific
      antibody levels generally develop in the third week following vaccination.
    

Intervention name(s): vaccine made by Beijing Minhai Biotechnology Co., Ltd; vaccine made by Chengdu Institute of Biological Products
Intervention type(s): Biological; Biological
Intervention description(s): Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.; Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Pneumococcal vaccine