Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | September 2012 |
| End Date: | March 2014 |
| Contact: | Julia Siik, BSN |
| Email: | siikjk@evms.edu |
| Phone: | 757-446-5080 |
Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes 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 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
Oral polio vaccine (OPV) will not be sufficient to eradicate polio. OPV has failed to
provide adequate polio immunity in certain immunocompromised populations, such as people
with AIDS. Also, OPV can mutate and form neurovirulent strains capable of causing polio
outbreaks. Inactivated polio vaccine (IPV), which cannot mutate into neurovirulent strains
and which is more effective in populations that have failed to respond to OPV, will be
needed globally to eradicate polio, but it is unaffordable for many developing countries.
Because there are more immune cells in the skin than in the muscle, intradermal
administration of IPV may be a way to increase the efficacy and reduce the dose (and thus
the cost) of IPV. We plan to conduct a clinical trial randomizing 231 HIV-infected adults
to receive a booster of two-fifths dose intradermal IPV, one-fifth dose intradermal IPV,
full dose intramuscular IPV, or two-fifths dose intramuscular IPV. We will measure polio
immunity before and after vaccine administration. Through this study, we will determine the
optimal booster dose of intradermal IPV, whether intradermal works better than intramuscular
IPV administration, and whether intradermal IPV is effective in an immunocompromised
population. The data from this trial could contribute to global polio eradication.
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
We found this trial at
1
site
Click here to add this to my saved trials
