CompletedNCT01686503IDIPVUpdated Feb 5, 2015Results posted

Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects

A Phase 2 interventional study of IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose in Polio Immunity, sponsored by Eastern Virginia Medical School. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-02-05.

Sponsored by Eastern Virginia Medical School · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 231
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study 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

Read the 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.

Conditions studied

Polio Immunity

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In context

Poliomyelitis

222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.

This study's enrollment of 231 is below the median of 456 across 199 interventional studies indexed under Poliomyelitis.

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Lead sponsor

Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
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

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

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 231 participants (actual)

Study arms

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
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
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
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

Interventions

DrugIPOL (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.
Also known as: IPOL (Sanofi Pasteur)

What researchers measure

Primary outcomes

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.
Time frame: 4-6 weeks after receiving the vaccine

Secondary outcomes

Baseline Polio Neutralizing Antibody Titers
serum polio neutralizing antibody titers prior to the vaccine booster
Time frame: first visit

Results

Posted Feb 5, 2015

Limitations and caveats

Higher baseline antibody titers than expected making it more difficult to detect differences between the study groups.

Participant flow

Participant flow — Overall Study
Milestone	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV
Started	66	66	66	33
Completed	65	63	64	32
Not completed	1	3	2	1

Outcome measures

PrimaryPost 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.

Time frame:: 4-6 weeks after receiving the vaccine
Reported as:: Geometric mean · antibody titers

Post Booster Polio Neutralizing Antibody Titers
antibody titers	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV
Serotype 1	1715 (1174 to 2504)	976 (730 to 1304)	1249 (916 to 1705)	1328 (795 to 2219)
Serotype 2	2188 (1507 to 3178)	1438 (984 to 2101)	1489 (1041 to 2128)	1938 (1232 to 3047)
Serotype 3	2375 (1423 to 3963)	1698 (1114 to 2588)	1792 (1133 to 2835)	2075 (1225 to 3514)

SecondaryBaseline Polio Neutralizing Antibody Titers

serum polio neutralizing antibody titers prior to the vaccine booster

Time frame:: first visit
Reported as:: Geometric mean · antibody titers

Baseline Polio Neutralizing Antibody Titers
antibody titers	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV
Serotype 1	44 (31 to 64)	42 (29 to 59)	42 (30 to 58)	34 (20 to 56)
Serotype 2	33 (24 to 44)	53 (37 to 76)	36 (26 to 51)	44 (29 to 66)
Serotype 3	14 (10 to 20)	20 (14 to 28)	16 (11 to 21)	11 (7 to 16)

Adverse events

Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
2/5 Dose Intradermal IPV	—	1/66 (1.5%)	33/66 (50%)
1/5 Dose Intadermal IPV	—	0/66 (0%)	29/66 (43.9%)
Full Dose Intramuscular IPV	—	0/66 (0%)	18/66 (27.3%)
2/5 Dose Intramuscular IPV	—	0/33 (0%)	10/33 (30.3%)

Most frequent serious events

Most frequent serious events
Event	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV
Hospitalization for electrolyte imbalances secondary to alcohol withdrawalRenal and urinary disorders	1/66	0/66	0/66	0/33

Most frequent other events

Most frequent other events
Event	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV
Redness at Injection SiteSkin and subcutaneous tissue disorders	19/66	22/66	4/66	3/33
Tenderness at Injection SiteGeneral disorders	10/66	8/66	11/66	5/33
Swelling at Injection SiteSkin and subcutaneous tissue disorders	5/66	7/66	3/66	2/33
Itching at injection siteSkin and subcutaneous tissue disorders	7/66	4/66	0/66	0/33
RashSkin and subcutaneous tissue disorders	1/66	1/66	4/66	2/33

Baseline characteristics

Age, Continuous
Age, Continuous(years)	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV	Total
Mean	45 ± 10	45 ± 11	46 ± 11	46 ± 11	46 ± 11

Sex: Female, Male
Sex: Female, Male(Participants)	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV	Total
Female	24	24	21	7	76
Male	42	42	45	26	155

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV	Total
Hispanic or Latino	3	5	0	0	8
Not Hispanic or Latino	62	60	66	33	221
Unknown or Not Reported	1	1	0	0	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	47	48	47	21	163
White	19	17	19	11	66
More than one race	0	0	0	0	0
Unknown or Not Reported	0	1	0	1	2

Most recent CD4 count
Most recent CD4 count(cells/mm^3)	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV	Total
Mean	669 ± 361	630 ± 331	676 ± 354	569 ± 260	645 ± 338

Currently on antiretroviral therapy
Currently on antiretroviral therapy(participants)	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV	Total
Number	64	64	66	33	227

Diagnosis of AIDS in the record
Diagnosis of AIDS in the record(participants)	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV	Total
Number	38	33	39	17	127

Year diagnosed with HIV
Year diagnosed with HIV(calendar year)	2/5 Dose Intradermal IPV	1/5 Dose Intadermal IPV	Full Dose Intramuscular IPV	2/5 Dose Intramuscular IPV	Total
Mean	2001 ± 8	2002 ± 8	2001 ± 8	2001 ± 9	2002 ± 8

6 further baseline measures are reported on the registry.

Study locations

1 site

C3ID Clinic, Eastern Virginia Medical School
Norfolk, Virginia 23507, United States

References and documents

Publications

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. PubMed 25567841 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01686503
Lead sponsor: Eastern Virginia Medical School
Collaborators: NanoPass Technologies Ltd
Responsible party: Stephanie Troy (Assistant Professor, Eastern Virginia Medical School) — Principal investigator
First posted: Sep 18, 2012
Start date: Sep 2012
Primary completion: Aug 2013
Completion: Aug 2013
Results posted: Feb 5, 2015
Last update: Feb 5, 2015

Study contacts

Stephanie B Troy, MD

principal investigator · Eastern Virginia Medical School

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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