Phase 2
N=231
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
Polio Immunity
Bottom Line
View on ClinicalTrials.gov: NCT01686503 ↗Enrolled (actual)
231
Serious AEs
0.4%
Results posted
Feb 2015
Primary outcome: Primary: Post Booster Polio Neutralizing Antibody Titers — 1715; 976; 1249; 1328 antibody titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Virginia Medical School
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Booster Polio Neutralizing Antibody Titers |
1715; 976; 1249; 1328; 2188; 1438 | — |
| SECONDARY Baseline Polio Neutralizing Antibody Titers |
44; 42; 42; 34; 33; 53 | — |
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
Eligibility Criteria
Inclusion Criteria
- documented HIV infection
- age of at least 18 years old
- HIV viral load <400 on the most recent test
Exclusion Criteria
- current acute moderate to severe illness (demonstrated by fever over 100.4 Fahrenheit, shortness of breath, altered mental status, or by judgment of the primary clinician)
- current pregnancy
- history of allergic reaction to a polio shot,
- history of a life-threatening allergic reaction to neomycin, streptomycin, or polymyxin B
Data sourced from ClinicalTrials.gov (NCT01686503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.