Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00436046
First received: February 15, 2007
Last updated: June 9, 2011
Last verified: October 2009
Results First Received: October 9, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Trivalent inactivated influenza virus vaccine (2006-2007 formulation)
Biological: Type 1 interferon

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy ambulatory adults were recruited from the surrounding community of the research clinic from March 16, 2007 through March 21, 2007.

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
IVV With 1M IFN IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
IVV Without IFN IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
IVV With 10M IFN IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].

Participant Flow:   Overall Study
    IVV With 1M IFN     IVV Without IFN     IVV With 10M IFN  
STARTED     32     32     31  
COMPLETED     32     32     31  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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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
IVV With 1M IFN IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
IVV Without IFN IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
IVV With 10M IFN IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
Total Total of all reporting groups

Baseline Measures
    IVV With 1M IFN     IVV Without IFN     IVV With 10M IFN     Total  
Number of Participants  
[units: participants]
  32     32     31     95  
Age  
[units: participants]
       
<=18 years     0     1     0     1  
Between 18 and 65 years     32     31     31     94  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  25.3  ± 5.2     25.2  ± 4.8     24.7  ± 4.9     25.1  ± 4.9  
Gender  
[units: participants]
       
Female     22     18     23     63  
Male     10     14     8     32  
Region of Enrollment  
[units: participants]
       
United States     32     32     31     95  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.   [ Time Frame: 14 days after immunization. ]

2.  Primary:   Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization   [ Time Frame: 28 days after immunization. ]

3.  Secondary:   Local and/or Systemic Solicited Symptoms After Intranasal Immunization.   [ Time Frame: 0-7 days following immunization ]

4.  Secondary:   Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.   [ Time Frame: 14 days after immunization. ]

5.  Secondary:   Unsolicited Adverse Events After Intranasal Immunization   [ Time Frame: Non-serious AEs are collected through 28 days after vaccination. Serious AEs are collected through 180 days after vaccination. ]

6.  Secondary:   Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.   [ Time Frame: 28 days after immunization ]

7.  Other Pre-specified:   Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 14 Days After Intranasal Immunization.   [ Time Frame: 14 days after immunization ]

8.  Other Pre-specified:   Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 28 Days After Intranasal Immunization.   [ Time Frame: 28 days after immunization ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Robert Couch, MD
Organization: Baylor College of Medicine
phone: 713-798-4474
e-mail: rcouch@bcm.tmc.edu


No publications provided


Responsible Party: Director, ORA, HHS/NIAID/DMID
ClinicalTrials.gov Identifier: NCT00436046     History of Changes
Other Study ID Numbers: 06-0074, N01AI30039C
Study First Received: February 15, 2007
Results First Received: October 9, 2008
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration