FindTrial
Sign In

Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01686503
Acronym
IDIPV
Enrollment
231
Registered
2012-09-18
Start date
2012-09-30
Completion date
2013-08-31
Last updated
2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polio Immunity

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.

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.

Sponsors

NanoPass Technologies Ltd
CollaboratorINDUSTRY
Eastern Virginia Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Post Booster Polio Neutralizing Antibody Titers4-6 weeks after receiving the vaccineBlood 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

MeasureTime frameDescription
Baseline Polio Neutralizing Antibody Titersfirst visitserum polio neutralizing antibody titers prior to the vaccine booster

Countries

United States

Participant flow

Participants by arm

ArmCount
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 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.
66
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. 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.
66
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. 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.
66
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. 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.
33
Total231

Baseline characteristics

Characteristic1/5 Dose Intadermal IPVTotal2/5 Dose Intradermal IPV2/5 Dose Intramuscular IPVFull Dose Intramuscular IPV
Age, Continuous45 years
STANDARD_DEVIATION 11
46 years
STANDARD_DEVIATION 11
45 years
STANDARD_DEVIATION 10
46 years
STANDARD_DEVIATION 11
46 years
STANDARD_DEVIATION 11
Born in the United States63 participants219 participants65 participants31 participants60 participants
Coinfected with hepatitis B4 participants13 participants7 participants0 participants2 participants
Coinfected with hepatitis C10 participants33 participants12 participants5 participants6 participants
Currently on antiretroviral therapy64 participants227 participants64 participants33 participants66 participants
Current smoker31 participants105 participants38 participants13 participants23 participants
Diagnosis of AIDS in the record33 participants127 participants38 participants17 participants39 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants8 Participants3 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
60 Participants221 Participants62 Participants33 Participants66 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants0 Participants0 Participants
Lived or traveled internationally19 participants78 participants18 participants12 participants29 participants
Most recent CD4 count630 cells/mm^3
STANDARD_DEVIATION 331
645 cells/mm^3
STANDARD_DEVIATION 338
669 cells/mm^3
STANDARD_DEVIATION 361
569 cells/mm^3
STANDARD_DEVIATION 260
676 cells/mm^3
STANDARD_DEVIATION 354
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
48 Participants163 Participants47 Participants21 Participants47 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
White
17 Participants66 Participants19 Participants11 Participants19 Participants
Reported receiving all childhood vaccines64 participants219 participants64 participants31 participants60 participants
Sex: Female, Male
Female
24 Participants76 Participants24 Participants7 Participants21 Participants
Sex: Female, Male
Male
42 Participants155 Participants42 Participants26 Participants45 Participants
Year diagnosed with HIV2002 calendar year
STANDARD_DEVIATION 8
2002 calendar year
STANDARD_DEVIATION 8
2001 calendar year
STANDARD_DEVIATION 8
2001 calendar year
STANDARD_DEVIATION 9
2001 calendar year
STANDARD_DEVIATION 8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
33 / 6629 / 6618 / 6610 / 33
serious
Total, serious adverse events
1 / 660 / 660 / 660 / 33

Outcome results

Primary

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

ArmMeasureGroupValue (GEOMETRIC_MEAN)
2/5 Dose Intradermal IPVPost Booster Polio Neutralizing Antibody TitersSerotype 11715 antibody titers
2/5 Dose Intradermal IPVPost Booster Polio Neutralizing Antibody TitersSerotype 32375 antibody titers
2/5 Dose Intradermal IPVPost Booster Polio Neutralizing Antibody TitersSerotype 22188 antibody titers
1/5 Dose Intadermal IPVPost Booster Polio Neutralizing Antibody TitersSerotype 1976 antibody titers
1/5 Dose Intadermal IPVPost Booster Polio Neutralizing Antibody TitersSerotype 21438 antibody titers
1/5 Dose Intadermal IPVPost Booster Polio Neutralizing Antibody TitersSerotype 31698 antibody titers
Full Dose Intramuscular IPVPost Booster Polio Neutralizing Antibody TitersSerotype 21489 antibody titers
Full Dose Intramuscular IPVPost Booster Polio Neutralizing Antibody TitersSerotype 11249 antibody titers
Full Dose Intramuscular IPVPost Booster Polio Neutralizing Antibody TitersSerotype 31792 antibody titers
2/5 Dose Intramuscular IPVPost Booster Polio Neutralizing Antibody TitersSerotype 32075 antibody titers
2/5 Dose Intramuscular IPVPost Booster Polio Neutralizing Antibody TitersSerotype 21938 antibody titers
2/5 Dose Intramuscular IPVPost Booster Polio Neutralizing Antibody TitersSerotype 11328 antibody titers
Secondary

Baseline Polio Neutralizing Antibody Titers

serum polio neutralizing antibody titers prior to the vaccine booster

Time frame: first visit

ArmMeasureGroupValue (GEOMETRIC_MEAN)
2/5 Dose Intradermal IPVBaseline Polio Neutralizing Antibody TitersSerotype 144 antibody titers
2/5 Dose Intradermal IPVBaseline Polio Neutralizing Antibody TitersSerotype 314 antibody titers
2/5 Dose Intradermal IPVBaseline Polio Neutralizing Antibody TitersSerotype 233 antibody titers
1/5 Dose Intadermal IPVBaseline Polio Neutralizing Antibody TitersSerotype 142 antibody titers
1/5 Dose Intadermal IPVBaseline Polio Neutralizing Antibody TitersSerotype 320 antibody titers
1/5 Dose Intadermal IPVBaseline Polio Neutralizing Antibody TitersSerotype 253 antibody titers
Full Dose Intramuscular IPVBaseline Polio Neutralizing Antibody TitersSerotype 236 antibody titers
Full Dose Intramuscular IPVBaseline Polio Neutralizing Antibody TitersSerotype 142 antibody titers
Full Dose Intramuscular IPVBaseline Polio Neutralizing Antibody TitersSerotype 316 antibody titers
2/5 Dose Intramuscular IPVBaseline Polio Neutralizing Antibody TitersSerotype 134 antibody titers
2/5 Dose Intramuscular IPVBaseline Polio Neutralizing Antibody TitersSerotype 311 antibody titers
2/5 Dose Intramuscular IPVBaseline Polio Neutralizing Antibody TitersSerotype 244 antibody titers

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026