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临床试验/NCT01686503
NCT01686503已完成2 期

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

Eastern Virginia Medical School1 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
231
试验地点
1
主要终点
Post Booster Polio Neutralizing Antibody Titers

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • documented HIV infection
  • age of at least 18 years old
  • HIV viral load <400 on the most recent test

排除标准

  • 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

研究组 & 干预措施

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

干预措施: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (Drug)

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.

干预措施: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (Drug)

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.

干预措施: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (Drug)

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.

干预措施: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (Drug)

结局指标

主要结局

Post Booster Polio Neutralizing Antibody Titers

时间窗: 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.

次要结局

  • Baseline Polio Neutralizing Antibody Titers(first visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie Troy

Assistant Professor

Eastern Virginia Medical School

研究点 (1)

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