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NCT01686503 · ClinicalTrials.gov registry record · Phase 2
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
A Phase 2 study, sponsored by Eastern Virginia Medical School.
- Completed
- Registry status
- Phase 2
- Development phase
- 231
- Enrollment target
NCT01686503: Completed Phase 2 study, sponsored by Eastern Virginia Medical School.
NCT01686503 is a Phase 2 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 231 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01686503, a Phase 2 study, has completed, sponsored by Eastern Virginia Medical School.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 231 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether a lower dose of inactivated polio vaccine (IPV) injected into the skin (intradermal administration) can work equally well or better than the standard dose injected into the muscle (intramuscular administration). There are more immune cells in the skin than in the muscle, and other vaccines have been shown to require a lower dose when administered intradermally. The study is being done in participants infected with HIV because HIV-infected people are known to respond less well to vaccines than other groups, so it is particularly important to know if IPV might work better in HIV-infected people if administered intradermally. If it is possible to lower the dose of IPV by intradermal administration, this would make inactivated polio vaccine more affordable in the developing countries where it is most needed
Primary Outcome
Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.
Interventions
- DRUG IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01686503 record still lists
NCT01686503 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher).
The record links to 0 conditions, and to 1 intervention - of which IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose is the first listed.
NCT01686503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01686503 about?
NCT01686503 is a clinical study titled "Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects". The purpose of this study is to determine whether a lower dose of inactivated polio vaccine (IPV) injected into the skin (intradermal administration) can work equally well or better than the standard dose injected into the muscle (intramuscular administration). There are more immune cells in the ski...
What is the current status of trial NCT01686503?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 231 participants. The study started on 2012-09. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01686503?
The interventions under investigation include: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (DRUG).
Who is sponsoring clinical trial NCT01686503?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01686503's enrollment target sits among peer trials
231 257th of 2000 higher than 1,744 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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