Systems Biology of PNEUMOVAX®23 and PREVNAR 13®
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Study type: Interventional

Summary: 
      Vaccination is the most effective way of preventing infectious diseases. Despite the success
      of vaccines in general, vaccines induce diminished antibody responses and lower protection in
      the elderly in particular. This could be explained by a defect in the early responses of an
      ageing immune system. A better understanding of the basic immunological mechanisms that
      mediate vaccine efficacy is incomplete. Such information is critical and could greatly
      decrease both the cost and the time to new vaccine development particularly for the geriatric
      population.

      In this trial, the investigators will study the immunologic differences of two FDA approved
      licensed pneumococcal vaccines between a younger and an older group. Twenty two healthy
      volunteers between the age of 25-40 and sixty six healthy volunteers between the ages of
      60-89 will be enrolled in the study. Each participant in the study will be given one
      pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days,
      seven days, fourteen days, as well as one month and six months after vaccination. Throughout
      the duration of the study, the participants will be monitored for safety.
    

Detailed description: 
      RATIONALE: PCV13 [13-valent pneumococcal conjugate vaccine (Prevnar®13)] induces better
      functional immune responses when compared to PPV23 [23-valent pneumococcal polysaccharide
      vaccine (Pneumovax®23)] in older naïve adults. We hypothesize that this is due to intrinsic
      defects in innate responses that could explain the poor immunogenicity of PPV23 when compared
      to PCV13. Therefore, we propose to extensively study innate and adaptive immune responses
      generated after administration of either pneumococcal polysaccharide or conjugate vaccines in
      older adults.

      STUDY DESIGN: Single center, open label study in which adult healthy volunteers will be
      vaccinated with either PPV23 or PCV13. Blood samples will be collected on Days D0 (at
      enrollment) and D1, D3, D7, D14, D30 and D180 post vaccination to study innate and adaptive
      immune responses.

      Even though PPV23 and PCV13 are considered safe, volunteers will be asked to report any local
      or systemic AEs from Day 0 (vaccination) to Day 7 . Reactogenicity events will also be
      evaluated by injection site examination on visits at D0, D1, D3 and D7. Also volunteers are
      asked to report any local or systemic AEs for 30 days post vaccination and any SAEs for 180
      days post vaccination. Volunteers are also asked to report local and systemic AEs developing
      the day of a blood draw.
    

Intervention name(s): PNEUMOVAX; Prevnar
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose of PNEUMOVAX; 1 dose of Prevnar
Other intervention name(s): 23-valent polysaccharide pneumococcal vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pneumococcal vaccine; immune responses