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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    2/5 Dose Intradermal IPV   1/5 Dose Intadermal IPV   Full Dose Intramuscular IPV   2/5 Dose Intramuscular IPV
STARTED   66   66   66   33 
COMPLETED   65   63   64   32 
NOT COMPLETED   1   3   2   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   2/5 Dose Intradermal IPV   1/5 Dose Intadermal IPV   Full Dose Intramuscular IPV   2/5 Dose Intramuscular IPV   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   66   66   33   231 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (10)   45  (11)   46  (11)   46  (11)   46  (11) 
Gender 
[Units: Participants]
         
Female   24   24   21   7   76 
Male   42   42   45   26   155 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   3   5   0   0   8 
Not Hispanic or Latino   62   60   66   33   221 
Unknown or Not Reported   1   1   0   0   2 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   47   48   47   21   163 
White   19   17   19   11   66 
More than one race   0   0   0   0   0 
Unknown or Not Reported   0   1   0   1   2 
Most recent CD4 count 
[Units: Cells/mm^3]
Mean (Standard Deviation)
 669  (361)   630  (331)   676  (354)   569  (260)   645  (338) 
Currently on antiretroviral therapy 
[Units: Participants]
 64   64   66   33   227 
Diagnosis of AIDS in the record 
[Units: Participants]
 38   33   39   17   127 
Year diagnosed with HIV 
[Units: Calendar year]
Mean (Standard Deviation)
 2001  (8)   2002  (8)   2001  (8)   2001  (9)   2002  (8) 
Born in the United States 
[Units: Participants]
 65   63   60   31   219 
Lived or traveled internationally 
[Units: Participants]
 18   19   29   12   78 
Reported receiving all childhood vaccines 
[Units: Participants]
 64   64   60   31   219 
Current smoker 
[Units: Participants]
 38   31   23   13   105 
Coinfected with hepatitis C 
[Units: Participants]
 12   10   6   5   33 
Coinfected with hepatitis B 
[Units: Participants]
 7   4   2   0   13 


  Outcome Measures

1.  Primary:   Post Booster Polio Neutralizing Antibody Titers   [ Time Frame: 4-6 weeks after receiving the vaccine ]

2.  Secondary:   Baseline Polio Neutralizing Antibody Titers   [ Time Frame: first visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Higher baseline antibody titers than expected making it more difficult to detect differences between the study groups.


  More Information

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
e-mail: troysb@evms.edu


Publications of Results:

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