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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
NanoPass Technologies Ltd
Information provided by (Responsible Party):
Stephanie Troy, Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01686503
First received: September 13, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Polio Immunity
Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • Increase in polio neutralizing antibody titers [ Time Frame: 4-6 weeks after receiving the vaccine ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 231
Study Start Date: September 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 intadermal 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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686503

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

No publications provided

Responsible Party: Stephanie Troy, Assistant Professor, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01686503     History of Changes
Other Study ID Numbers: Doris Duke CF-2012061
Study First Received: September 13, 2012
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 22, 2014