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Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects (IDIPV)

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ClinicalTrials.gov Identifier: NCT01686503
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : February 5, 2015
Last Update Posted : February 5, 2015
Sponsor:
Collaborator:
NanoPass Technologies Ltd
Information provided by (Responsible Party):
Stephanie Troy, Eastern Virginia Medical School

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Polio Immunity
Intervention Drug: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose
Enrollment 231

Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2/5 Dose Intradermal IPV 1/5 Dose Intadermal IPV Full Dose Intramuscular IPV 2/5 Dose Intramuscular IPV
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 66 66 66 33
Completed 65 63 64 32
Not Completed 1 3 2 1
Arm/Group Title 2/5 Dose Intradermal IPV 1/5 Dose Intadermal IPV Full Dose Intramuscular IPV 2/5 Dose Intramuscular IPV Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 66 66 66 33 231
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
45  (10) 45  (11) 46  (11) 46  (11) 46  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
Female
24
  36.4%
24
  36.4%
21
  31.8%
7
  21.2%
76
  32.9%
Male
42
  63.6%
42
  63.6%
45
  68.2%
26
  78.8%
155
  67.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
Hispanic or Latino
3
   4.5%
5
   7.6%
0
   0.0%
0
   0.0%
8
   3.5%
Not Hispanic or Latino
62
  93.9%
60
  90.9%
66
 100.0%
33
 100.0%
221
  95.7%
Unknown or Not Reported
1
   1.5%
1
   1.5%
0
   0.0%
0
   0.0%
2
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
47
  71.2%
48
  72.7%
47
  71.2%
21
  63.6%
163
  70.6%
White
19
  28.8%
17
  25.8%
19
  28.8%
11
  33.3%
66
  28.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.5%
0
   0.0%
1
   3.0%
2
   0.9%
Most recent CD4 count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
669  (361) 630  (331) 676  (354) 569  (260) 645  (338)
Currently on antiretroviral therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
64 64 66 33 227
Diagnosis of AIDS in the record  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
38 33 39 17 127
Year diagnosed with HIV  
Mean (Standard Deviation)
Unit of measure:  Calendar year
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
2001  (8) 2002  (8) 2001  (8) 2001  (9) 2002  (8)
Born in the United States  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
65 63 60 31 219
Lived or traveled internationally  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
18 19 29 12 78
Reported receiving all childhood vaccines  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
64 64 60 31 219
Current smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
38 31 23 13 105
Coinfected with hepatitis C  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
12 10 6 5 33
Coinfected with hepatitis B  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 66 participants 66 participants 33 participants 231 participants
7 4 2 0 13
1.Primary Outcome
Title Post Booster Polio Neutralizing Antibody Titers
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2/5 Dose Intradermal IPV 1/5 Dose Intadermal IPV Full Dose Intramuscular IPV 2/5 Dose Intramuscular IPV
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 65 63 64 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: antibody titers
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)
2.Secondary Outcome
Title Baseline Polio Neutralizing Antibody Titers
Hide Description serum polio neutralizing antibody titers prior to the vaccine booster
Time Frame first visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2/5 Dose Intradermal IPV 1/5 Dose Intadermal IPV Full Dose Intramuscular IPV 2/5 Dose Intramuscular IPV
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 65 63 64 32
Geometric Mean (95% Confidence Interval)
Unit of Measure: antibody titers
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2/5 Dose Intradermal IPV 1/5 Dose Intadermal IPV Full Dose Intramuscular IPV 2/5 Dose Intramuscular IPV
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
2/5 Dose Intradermal IPV 1/5 Dose Intadermal IPV Full Dose Intramuscular IPV 2/5 Dose Intramuscular IPV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2/5 Dose Intradermal IPV 1/5 Dose Intadermal IPV Full Dose Intramuscular IPV 2/5 Dose Intramuscular IPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/66 (1.52%)      0/66 (0.00%)      0/66 (0.00%)      0/33 (0.00%)    
Renal and urinary disorders         
Hospitalization for electrolyte imbalances secondary to alcohol withdrawal [1]  1/66 (1.52%)  1 0/66 (0.00%)  0 0/66 (0.00%)  0 0/33 (0.00%)  0
[1]
Occured one month after receiving the vaccine
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
2/5 Dose Intradermal IPV 1/5 Dose Intadermal IPV Full Dose Intramuscular IPV 2/5 Dose Intramuscular IPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/66 (50.00%)      29/66 (43.94%)      18/66 (27.27%)      10/33 (30.30%)    
General disorders         
Tenderness at Injection Site  10/66 (15.15%)  10 8/66 (12.12%)  8 11/66 (16.67%)  11 5/33 (15.15%)  5
Skin and subcutaneous tissue disorders         
Rash  1/66 (1.52%)  1 1/66 (1.52%)  1 4/66 (6.06%)  4 2/33 (6.06%)  2
Redness at Injection Site  19/66 (28.79%)  19 22/66 (33.33%)  22 4/66 (6.06%)  4 3/33 (9.09%)  3
Swelling at Injection Site  5/66 (7.58%)  5 7/66 (10.61%)  7 3/66 (4.55%)  3 2/33 (6.06%)  2
Itching at injection site  7/66 (10.61%)  7 4/66 (6.06%)  4 0/66 (0.00%)  0 0/33 (0.00%)  0
Higher baseline antibody titers than expected making it more difficult to detect differences between the study groups.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Stephanie Troy
Organization: Eastern Virginia Medical School
Phone: 757-446-8999
Responsible Party: Stephanie Troy, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01686503     History of Changes
Other Study ID Numbers: Doris Duke CF-2012061
First Submitted: September 13, 2012
First Posted: September 18, 2012
Results First Submitted: January 13, 2015
Results First Posted: February 5, 2015
Last Update Posted: February 5, 2015