Trial Outcomes & Findings for Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects (NCT NCT01686503)
NCT ID: NCT01686503
Last Updated: 2015-02-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
231 participants
Primary outcome timeframe
4-6 weeks after receiving the vaccine
Results posted on
2015-02-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
66
|
33
|
|
Overall Study
COMPLETED
|
65
|
63
|
64
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
Baseline characteristics by cohort
| Measure |
2/5 Dose Intradermal IPV
n=66 Participants
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.
|
1/5 Dose Intadermal IPV
n=66 Participants
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.
|
Full Dose Intramuscular IPV
n=66 Participants
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.
|
2/5 Dose Intramuscular IPV
n=33 Participants
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
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 10 • n=39 Participants
|
45 years
STANDARD_DEVIATION 11 • n=41 Participants
|
46 years
STANDARD_DEVIATION 11 • n=35 Participants
|
46 years
STANDARD_DEVIATION 11 • n=31 Participants
|
46 years
STANDARD_DEVIATION 11 • n=146 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
76 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
155 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=39 Participants
|
60 Participants
n=41 Participants
|
66 Participants
n=35 Participants
|
33 Participants
n=31 Participants
|
221 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=39 Participants
|
48 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
163 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
66 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Most recent CD4 count
|
669 cells/mm^3
STANDARD_DEVIATION 361 • n=39 Participants
|
630 cells/mm^3
STANDARD_DEVIATION 331 • n=41 Participants
|
676 cells/mm^3
STANDARD_DEVIATION 354 • n=35 Participants
|
569 cells/mm^3
STANDARD_DEVIATION 260 • n=31 Participants
|
645 cells/mm^3
STANDARD_DEVIATION 338 • n=146 Participants
|
|
Currently on antiretroviral therapy
|
64 participants
n=39 Participants
|
64 participants
n=41 Participants
|
66 participants
n=35 Participants
|
33 participants
n=31 Participants
|
227 participants
n=146 Participants
|
|
Diagnosis of AIDS in the record
|
38 participants
n=39 Participants
|
33 participants
n=41 Participants
|
39 participants
n=35 Participants
|
17 participants
n=31 Participants
|
127 participants
n=146 Participants
|
|
Year diagnosed with HIV
|
2001 calendar year
STANDARD_DEVIATION 8 • n=39 Participants
|
2002 calendar year
STANDARD_DEVIATION 8 • n=41 Participants
|
2001 calendar year
STANDARD_DEVIATION 8 • n=35 Participants
|
2001 calendar year
STANDARD_DEVIATION 9 • n=31 Participants
|
2002 calendar year
STANDARD_DEVIATION 8 • n=146 Participants
|
|
Born in the United States
|
65 participants
n=39 Participants
|
63 participants
n=41 Participants
|
60 participants
n=35 Participants
|
31 participants
n=31 Participants
|
219 participants
n=146 Participants
|
|
Lived or traveled internationally
|
18 participants
n=39 Participants
|
19 participants
n=41 Participants
|
29 participants
n=35 Participants
|
12 participants
n=31 Participants
|
78 participants
n=146 Participants
|
|
Reported receiving all childhood vaccines
|
64 participants
n=39 Participants
|
64 participants
n=41 Participants
|
60 participants
n=35 Participants
|
31 participants
n=31 Participants
|
219 participants
n=146 Participants
|
|
Current smoker
|
38 participants
n=39 Participants
|
31 participants
n=41 Participants
|
23 participants
n=35 Participants
|
13 participants
n=31 Participants
|
105 participants
n=146 Participants
|
|
Coinfected with hepatitis C
|
12 participants
n=39 Participants
|
10 participants
n=41 Participants
|
6 participants
n=35 Participants
|
5 participants
n=31 Participants
|
33 participants
n=146 Participants
|
|
Coinfected with hepatitis B
|
7 participants
n=39 Participants
|
4 participants
n=41 Participants
|
2 participants
n=35 Participants
|
0 participants
n=31 Participants
|
13 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 4-6 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.
Outcome measures
| Measure |
2/5 Dose Intradermal IPV
n=65 Participants
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.
|
1/5 Dose Intadermal IPV
n=63 Participants
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.
|
Full Dose Intramuscular IPV
n=64 Participants
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.
|
2/5 Dose Intramuscular IPV
n=32 Participants
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.
|
|---|---|---|---|---|
|
Post Booster Polio Neutralizing Antibody Titers
Serotype 1
|
1715 antibody titers
Interval 1174.0 to 2504.0
|
976 antibody titers
Interval 730.0 to 1304.0
|
1249 antibody titers
Interval 916.0 to 1705.0
|
1328 antibody titers
Interval 795.0 to 2219.0
|
|
Post Booster Polio Neutralizing Antibody Titers
Serotype 2
|
2188 antibody titers
Interval 1507.0 to 3178.0
|
1438 antibody titers
Interval 984.0 to 2101.0
|
1489 antibody titers
Interval 1041.0 to 2128.0
|
1938 antibody titers
Interval 1232.0 to 3047.0
|
|
Post Booster Polio Neutralizing Antibody Titers
Serotype 3
|
2375 antibody titers
Interval 1423.0 to 3963.0
|
1698 antibody titers
Interval 1114.0 to 2588.0
|
1792 antibody titers
Interval 1133.0 to 2835.0
|
2075 antibody titers
Interval 1225.0 to 3514.0
|
SECONDARY outcome
Timeframe: first visitserum polio neutralizing antibody titers prior to the vaccine booster
Outcome measures
| Measure |
2/5 Dose Intradermal IPV
n=65 Participants
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.
|
1/5 Dose Intadermal IPV
n=63 Participants
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.
|
Full Dose Intramuscular IPV
n=64 Participants
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.
|
2/5 Dose Intramuscular IPV
n=32 Participants
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.
|
|---|---|---|---|---|
|
Baseline Polio Neutralizing Antibody Titers
Serotype 1
|
44 antibody titers
Interval 31.0 to 64.0
|
42 antibody titers
Interval 29.0 to 59.0
|
42 antibody titers
Interval 30.0 to 58.0
|
34 antibody titers
Interval 20.0 to 56.0
|
|
Baseline Polio Neutralizing Antibody Titers
Serotype 2
|
33 antibody titers
Interval 24.0 to 44.0
|
53 antibody titers
Interval 37.0 to 76.0
|
36 antibody titers
Interval 26.0 to 51.0
|
44 antibody titers
Interval 29.0 to 66.0
|
|
Baseline Polio Neutralizing Antibody Titers
Serotype 3
|
14 antibody titers
Interval 10.0 to 20.0
|
20 antibody titers
Interval 14.0 to 28.0
|
16 antibody titers
Interval 11.0 to 21.0
|
11 antibody titers
Interval 7.0 to 16.0
|
Adverse Events
2/5 Dose Intradermal IPV
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
1/5 Dose Intadermal IPV
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Full Dose Intramuscular IPV
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
2/5 Dose Intramuscular IPV
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2/5 Dose Intradermal IPV
n=66 participants at risk
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.
|
1/5 Dose Intadermal IPV
n=66 participants at risk
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.
|
Full Dose Intramuscular IPV
n=66 participants at risk
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.
|
2/5 Dose Intramuscular IPV
n=33 participants at risk
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.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Hospitalization for electrolyte imbalances secondary to alcohol withdrawal
|
1.5%
1/66 • Number of events 1
|
0.00%
0/66
|
0.00%
0/66
|
0.00%
0/33
|
Other adverse events
| Measure |
2/5 Dose Intradermal IPV
n=66 participants at risk
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.
|
1/5 Dose Intadermal IPV
n=66 participants at risk
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.
|
Full Dose Intramuscular IPV
n=66 participants at risk
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.
|
2/5 Dose Intramuscular IPV
n=33 participants at risk
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.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/66 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
6.1%
4/66 • Number of events 4
|
6.1%
2/33 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Redness at Injection Site
|
28.8%
19/66 • Number of events 19
|
33.3%
22/66 • Number of events 22
|
6.1%
4/66 • Number of events 4
|
9.1%
3/33 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Swelling at Injection Site
|
7.6%
5/66 • Number of events 5
|
10.6%
7/66 • Number of events 7
|
4.5%
3/66 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
|
General disorders
Tenderness at Injection Site
|
15.2%
10/66 • Number of events 10
|
12.1%
8/66 • Number of events 8
|
16.7%
11/66 • Number of events 11
|
15.2%
5/33 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Itching at injection site
|
10.6%
7/66 • Number of events 7
|
6.1%
4/66 • Number of events 4
|
0.00%
0/66
|
0.00%
0/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place