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Influenza A 2009 H1N1 Challenge Study in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01646138
First received: July 18, 2012
Last updated: April 5, 2016
Last verified: April 2016
Results First Received: July 2, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Influenza
Intervention: Biological: Ca/04/2009/H1N1 Vero Grown Challenge Virus

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
49 participants were enrolled but 1 participant did not receive the intervention.

Reporting Groups
  Description
10^3 TCID 50 Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
10^4 TCID 50 Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
10^5 TCID 50 Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
10^6 TCID 50 Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
10^7 TCID 50 Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.

Participant Flow:   Overall Study
    10^3 TCID 50   10^4 TCID 50   10^5 TCID 50   10^6 TCID 50   10^7 TCID 50
STARTED   5   4   5   19   15 
COMPLETED   5   4   5   19   13 
NOT COMPLETED   0   0   0   0   2 
Lost to Follow-up                0                0                0                0                2 



  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
10^3 TCID 50 Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
10^4 TCID 50 Participants received influenza A(H1N1) pdm09 at a dose of 10^4 TCID50 administered intranasally.
10^5 TCID 50 Participants received influenza A(H1N1) pdm09 at a dose of 10^5 TCID50 administered intranasally.
10^6 TCID 50 Participants received influenza A(H1N1) pdm09 at a dose of 10^6 TCID50 administered intranasally.
10^7 TCID 50 Participants received influenza A(H1N1) pdm09 at a dose of 10^7 TCID50 administered intranasally.
Total Total of all reporting groups

Baseline Measures
   10^3 TCID 50   10^4 TCID 50   10^5 TCID 50   10^6 TCID 50   10^7 TCID 50   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   5   20   15   49 
Age 
[Units: Participants]
           
<=18 years   0   0   0   0   0   0 
Between 18 and 65 years   5   4   5   20   15   49 
>=65 years   0   0   0   0   0   0 
Gender 
[Units: Participants]
           
Female   2   0   3   9   5   19 
Male   3   4   2   11   10   30 
Ethnicity (NIH/OMB) 
[Units: Participants]
           
Hispanic or Latino   0   0   0   2   1   3 
Not Hispanic or Latino   5   4   5   18   14   46 
Unknown or Not Reported   0   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
           
American Indian or Alaska Native   0   0   0   0   0   0 
Asian   0   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0 
Black or African American   2   3   3   11   7   26 
White   3   1   2   6   7   19 
More than one race   0   0   0   1   0   1 
Unknown or Not Reported   0   0   0   2   1   3 


  Outcome Measures

1.  Primary:   Percent MMID   [ Time Frame: 67 days after influenza inoculation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Matthew J. Memoli
Organization: National Institute of Allergy and Infectious Diseases
phone: +1 301 443 5971
e-mail: memolim@niaid.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01646138     History of Changes
Other Study ID Numbers: 120077
12-I-0077 ( Other Identifier: NIH - National Institute of Allergy and Infectious Diseases )
Study First Received: July 18, 2012
Results First Received: July 2, 2015
Last Updated: April 5, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration