C3ID Clinic, Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
NCT Number: NCT01686503
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
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Notify Me18 year–90 year
All sexes
Interventional
Phase 2
Norfolk, Virginia, 23507, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.
Other names: IPOL (Sanofi Pasteur)
Time frame: 4-6 weeks after receiving the vaccine
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.
Time frame: first visit
serum polio neutralizing antibody titers prior to the vaccine booster
Eastern Virginia Medical School
Other
Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects
Acronym: IDIPV
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