Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects (IDIPV)

• ClinicalTrials.gov Identifier: NCT01686503
• Recruitment Status: Completed
• First Posted: September 18, 2012
• Results First Posted: February 5, 2015
• Last Update Posted: February 5, 2015
• Sponsor: Eastern Virginia Medical School
• Collaborator: NanoPass Technologies Ltd
• Information provided by (Responsible Party): Stephanie Troy, Eastern Virginia Medical School

Study Description

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

Condition or disease	Intervention/treatment	Phase
Polio Immunity	Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 231 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects
• Study Start Date: September 2012
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 2/5 dose intradermal IPV; 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; 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 Name: IPOL (Sanofi Pasteur)
Experimental: 1/5 dose intradermal IPV; 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; 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 Name: IPOL (Sanofi Pasteur)
Active Comparator: full dose intramuscular IPV; 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; 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 Name: IPOL (Sanofi Pasteur)
Active Comparator: 2/5 dose intramuscular IPV; 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; 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 Name: IPOL (Sanofi Pasteur)

Outcome Measures

Primary Outcome Measures :

1. Post Booster Polio Neutralizing Antibody Titers [ 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.

Secondary Outcome Measures :

1. Baseline Polio Neutralizing Antibody Titers [ Time Frame: first visit ]
   serum polio neutralizing antibody titers prior to the vaccine booster

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Virginia

C3ID Clinic, Eastern Virginia Medical School

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Eastern Virginia Medical School

NanoPass Technologies Ltd

Investigators

• Principal Investigator: Stephanie B Troy, MD; Eastern Virginia Medical School

More Information

Publications of Results:

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.

• Responsible Party: Stephanie Troy, Assistant Professor, Eastern Virginia Medical School
• ClinicalTrials.gov Identifier: NCT01686503
• Other Study ID Numbers: Doris Duke CF-2012061
• First Posted: September 18, 2012
• Results First Posted: February 5, 2015
• Last Update Posted: February 5, 2015
• Last Verified: January 2015

Additional relevant MeSH terms:

Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuromuscular Diseases