Systems Biology of PNEUMOVAX®23 and PREVNAR 13®
Systems Biology of 23 Valent Pneumococcal Polysaccharide Vaccine (PNEUMOVAX®23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®)
3 other identifiers
interventional
88
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
October 2, 2018
CompletedOctober 2, 2018
September 1, 2018
3.3 years
March 1, 2011
August 24, 2018
September 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Day 7
Secondary Outcomes (3)
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
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
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
Day 7
Study Arms (4)
Older Group on PREVNAR
EXPERIMENTALParticipants between the ages of 60-89 received PREVNAR
Younger Group on PREVNAR
EXPERIMENTALParticipants between the ages of 25-40 years received PREVNAR
Older Group on PNEUMOVAX
EXPERIMENTALParticipants between the ages of 60-89 received PNEUMOVAX
Younger Group on PNEUMOVAX
EXPERIMENTALParticipants between the ages of 25-40 years received PNEUMOVAX
Interventions
Eligibility Criteria
You may qualify if:
- Able to understand and give informed consent.
- Immunocompetent community dwelling subjects between the ages of ages of 25-40 and 60-89 years.
You may not qualify if:
- Prior vaccination with pneumococcal vaccine.
- Receipt of any of the following products:
- Blood products within 3 months prior to study entry or expected receipt at any time after study entry\*.
- Any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry\*.
- Any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry\*.
- Presence of co-morbidities or immunosuppressive states such as:
- Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, cerebrospinal fluid leaks, severe kidney disease, autoimmune diseases, severe gastrointestinal diseases and grade 4 hypertension per CTCAE criteria\*\* .
- Alcohol, drug abuse or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- Impaired immune function or known chronic infections including, but not limited, to known HIV, hepatitis B or C; organ transplant; immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids\*\*\* (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids\*\*\*\* or any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia and congenital immunodeficiency.
- Conditions that could affect the safety of the volunteers such as:
- o Severe reactions to prior vaccinations.
- o An allergy to any component of the study vaccines (phenol, aluminum, CRM197 protein, succinic acid, Polysorbate 80).
- History of Guillain-Barré syndrome.
- History of bleeding disorders.
- Volunteers with any acute illness\* including, but not limited to, - fever (\> 100.4 F \[\> 38 C\], regardless of the route) within 3 days prior to study entry.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rouphael, Nadine
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Nadine Rouphael, MD
Emory University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 1, 2011
First Posted
March 3, 2011
Study Start
April 1, 2014
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
October 2, 2018
Results First Posted
October 2, 2018
Record last verified: 2018-09