CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 231 enrolled
Drug / intervention
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dosedrug
Likely dose
IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose 0.2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01686503
NCT01686503Phase 2Completed

Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects

Eastern Virginia Medical School·interventional·Posted Sep 18, 2012·Updated Feb 5, 2015

In Brief

A Phase 2 clinical trial evaluating IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose for Polio Immunity. Completed, enrolled 231 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolio Immunity
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2012
Enrollment StartSep 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.8 years ago

Interventions

IPOL (Sanofi Pasteur) inactivated polio vaccine booster dosedrug

Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.