Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects (IDIPV)
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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 |
- 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 2014 |
| Estimated Primary Completion Date: | March 2014 (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 |
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| Contact: Julia Siik, BSN | 757-446-5080 | siikjk@evms.edu |
| United States, Virginia | |
| C3ID Clinic, Eastern Virginia Medical School | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Siik Julia, BSN 757-446-5080 siikjk@evms.edu | |
| Principal Investigator: Stephanie B. Troy, MD | |
| 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: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Poliomyelitis Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013