Clinical trial NCT01686503: Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
Official title: Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polio Immunity
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: NanoPass Technologies Ltd
First posted: 2012-09-18
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed description: 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.

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

Primary outcomes:
measure: Post Booster Polio Neutralizing Antibody Titers
timeFrame: 4-6 weeks after receiving the vaccine
Secondary outcomes:
measure: Baseline Polio Neutralizing Antibody Titers
timeFrame: first visit
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: C3ID Clinic, Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Stephanie B Troy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Troy SB, Kouiavskaia D, Siik J, Kochba E, Beydoun H, Mirochnitchenko O, Levin Y, Khardori N, Chumakov K, Maldonado Y. Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults. J Infect Dis. 2015 Jun 15;211(12):1969-76. doi: 10.1093/infdis/jiu841. Epub 2015 Jan 7.