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NCT01307449 · ClinicalTrials.gov registry record · NA
Systems Biology of PNEUMOVAX®23 and PREVNAR 13®
A NA study of Pneumococcal Infection, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 2
- Study locations
NCT01307449: Completed NA study of Pneumococcal Infection, sponsored by Emory University.
NCT01307449 is a NA study of Pneumococcal Infection that has completed, run by Emory University. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01307449, a NA study of Pneumococcal Infection, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL PNEUMOVAX
- BIOLOGICAL Prevnar
Study Locations (2)
Georgia
- Hope Clinic of the Emory Vaccine Center - Decatur
- Atlanta VA Medical Center - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2014-04 |
| Est. Completion | 2017-07 |
| Phase | NA |
What the finished NCT01307449 record still lists
NCT01307449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Pneumococcal Infection appearing as the primary indexed condition, and to 2 interventions - of which PNEUMOVAX is the first listed.
NCT01307449 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01307449 about?
NCT01307449 is a clinical study titled "Systems Biology of PNEUMOVAX®23 and PREVNAR 13®". 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....
What is the current status of trial NCT01307449?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2014-04. Estimated completion is 2017-07.
What conditions does trial NCT01307449 study?
This clinical trial studies the following conditions: Pneumococcal Infection.
What interventions are being tested in trial NCT01307449?
The interventions under investigation include: PNEUMOVAX (BIOLOGICAL), Prevnar (BIOLOGICAL).
Who is sponsoring clinical trial NCT01307449?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01307449 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01307449's enrollment target sits among peer trials
88 972nd of 2000 higher than 1,027 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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