Polio ImmunityPhase 2IDIPVNCT01686503
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
A Phase 2 study testing IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose in people with Polio Immunity, run by Eastern Virginia Medical School at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Polio Immunity
- What is being tested?
- IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented HIV infection
- age of at least 18 years old
- HIV viral load <400 on the most recent test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
C3ID Clinic, Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects
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
- Polio Immunity
- Being tested
- IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPOL (Sanofi Pasteur) inactivated polio vaccine booster doseDrug
Also called IPOL (Sanofi Pasteur)
Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 2/5 dose intradermal IPV | Experimental | 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 Receives: Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose |
| 1/5 dose intradermal IPV | Experimental | 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. Receives: Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose |
| full dose intramuscular IPV | Active comparator | 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. Receives: Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose |
| 2/5 dose intramuscular IPV | Active comparator | 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. Receives: Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 weeks after receiving the vaccine
Secondary outcomes (1)
Baseline Polio Neutralizing Antibody Titers
serum polio neutralizing antibody titers prior to the vaccine booster
Measured: first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polio ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- NanoPass Technologies Ltd
- Responsible party
- Principal investigator, Stephanie Troy, Eastern Virginia Medical School
- Investigators
- Stephanie B Troy, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686503
- Sponsor's protocol ID
- Doris Duke CF-2012061
- Acronym
- IDIPV
- Status last verified
- Jan 2015
- First submitted
- 13 Sep 2012
- Last updated
- 5 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Immunogenicity of Various Inactivated Polio Vaccine Booster Doses by Intradermal vs. Intramuscular Routes in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT01686503
- Acronym / sponsor ID
- IDIPV / Doris Duke CF-2012061
- Conditions
- Polio Immunity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- NanoPass Technologies Ltd
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 5 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2/5 dose intradermal IPV | Experimental | Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster doseParticipants 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 |
| 1/5 dose intradermal IPV | Experimental | Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster doseParticipants 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. |
| full dose intramuscular IPV | Active comparator | Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster doseParticipants 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. |
| 2/5 dose intramuscular IPV | Active comparator | Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster doseParticipants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- documented HIV infection
- age of at least 18 years old
- HIV viral load <400 on the most recent test
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPOL (Sanofi Pasteur) inactivated polio vaccine booster doseAlso: IPOL (Sanofi Pasteur)Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly. | Drug | 1/5 dose intradermal IPV, 2/5 dose intradermal IPV, 2/5 dose intramuscular IPV, full dose intramuscular IPV |
Primary outcome
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.
1 secondary outcome
Baseline Polio Neutralizing Antibody Titers
Time frame: first visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25567841Troy 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.
Related trials for Polio Immunity
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RecruitingPhase 3
A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie B Troy, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose in people with Polio Immunity, run by Eastern Virginia Medical School at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Booster Polio Neutralizing Antibody Titers (time frame: 4-6 weeks after receiving the vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.