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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
88
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M4.15
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR \< 0.05) positive enrichment of Monocyte Module M4.15 is reported.
Time frame: Day 7
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M11
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR \< 0.05) positive enrichment of Monocyte Module M11 is reported.
Time frame: Day 7
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M73
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR \< 0.05) positive enrichment of Monocyte Module M73 is reported.
Time frame: Day 7
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module S3
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR \< 0.05) positive enrichment of B cell module S3 is reported.
Time frame: Day 7
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.0
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR \< 0.05) positive enrichment of B cell module M156.0 is reported.
Time frame: Day 7
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.1
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR \< 0.05) positive enrichment of B cell module M156.1 is reported.
Time frame: Day 7
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