Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects

Study Overview
=================
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.

Official Title
-----------------
Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects

Conditions
-----------------
Polio Immunity

Intervention / Treatment
-----------------
* Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2/5 dose intradermal IPV<br>Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device | Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose<br>* Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.<br>* Other names: IPOL (Sanofi Pasteur);|
| Experimental: 1/5 dose intradermal IPV<br>Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device. | Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose<br>* Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.<br>* Other names: IPOL (Sanofi Pasteur);|
| Active Comparator: full dose intramuscular IPV<br>Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly. | Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose<br>* Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.<br>* Other names: IPOL (Sanofi Pasteur);|
| Active Comparator: 2/5 dose intramuscular IPV<br>Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly. | Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose<br>* Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.<br>* Other names: IPOL (Sanofi Pasteur);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Booster Polio Neutralizing Antibody Titers | 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. | 4-6 weeks after receiving the vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Polio Neutralizing Antibody Titers | serum polio neutralizing antibody titers prior to the vaccine booster | first visit |