Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Virginia Medical School
• Collaborator: NanoPass Technologies Ltd
• Treatments: Vaccines

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