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Influenza A 2009 H1N1 Challenge Study in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01646138
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Influenza
Intervention Biological: Ca/04/2009/H1N1 Vero Grown Challenge Virus
Enrollment 49
Recruitment Details  
Pre-assignment Details 49 participants were enrolled but 1 participant did not receive the intervention.
Arm/Group Title 10^3 TCID 50 10^4 TCID 50 10^5 TCID 50 10^6 TCID 50 10^7 TCID 50
Hide Arm/Group Description Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally. Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally. Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally. Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally. Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
Period Title: Overall Study
Started 5 4 5 19 15
Completed 5 4 5 19 13
Not Completed 0 0 0 0 2
Reason Not Completed
Lost to Follow-up             0             0             0             0             2
Arm/Group Title 10^3 TCID 50 10^4 TCID 50 10^5 TCID 50 10^6 TCID 50 10^7 TCID 50 Total
Hide Arm/Group Description Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally. Participants received influenza A(H1N1) pdm09 at a dose of 10^4 TCID50 administered intranasally. Participants received influenza A(H1N1) pdm09 at a dose of 10^5 TCID50 administered intranasally. Participants received influenza A(H1N1) pdm09 at a dose of 10^6 TCID50 administered intranasally. Participants received influenza A(H1N1) pdm09 at a dose of 10^7 TCID50 administered intranasally. Total of all reporting groups
Overall Number of Baseline Participants 5 4 5 20 15 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 5 participants 20 participants 15 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
4
 100.0%
5
 100.0%
20
 100.0%
15
 100.0%
49
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 5 participants 20 participants 15 participants 49 participants
Female
2
  40.0%
0
   0.0%
3
  60.0%
9
  45.0%
5
  33.3%
19
  38.8%
Male
3
  60.0%
4
 100.0%
2
  40.0%
11
  55.0%
10
  66.7%
30
  61.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 5 participants 20 participants 15 participants 49 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
1
   6.7%
3
   6.1%
Not Hispanic or Latino
5
 100.0%
4
 100.0%
5
 100.0%
18
  90.0%
14
  93.3%
46
  93.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 5 participants 20 participants 15 participants 49 participants
American Indian or Alaska Native
0
   0.0%
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%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
3
  75.0%
3
  60.0%
11
  55.0%
7
  46.7%
26
  53.1%
White
3
  60.0%
1
  25.0%
2
  40.0%
6
  30.0%
7
  46.7%
19
  38.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.0%
0
   0.0%
1
   2.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.0%
1
   6.7%
3
   6.1%
1.Primary Outcome
Title Percent MMID
Hide Description Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.
Time Frame 67 days after influenza inoculation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of the subjects who completed the study after receiving a particular dose of Ca/04/2009/H1N1 Vero Grown Challenge Virus.
Arm/Group Title 10^3 TCID 50 10^4 TCID 50 10^5 TCID 50 10^6 TCID 50 10^7 TCID 50
Hide Arm/Group Description:
Participants received influenza A(H1N1) pdm09 at a dose of 10^3 TCID 50 administered intranasally.
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
Overall Number of Participants Analyzed 5 4 5 19 13
Measure Type: Number
Unit of Measure: percentage of participants
0 0 20 47 69
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 10^3 TCID 50 10^4 TCID 50 10^5 TCID 50 10^6 TCID 50 10^7 TCID 50
Hide Arm/Group Description Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally. Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally. Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally. Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally. Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
All-Cause Mortality
10^3 TCID 50 10^4 TCID 50 10^5 TCID 50 10^6 TCID 50 10^7 TCID 50
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
10^3 TCID 50 10^4 TCID 50 10^5 TCID 50 10^6 TCID 50 10^7 TCID 50
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/4 (0.00%)   0/5 (0.00%)   0/19 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
10^3 TCID 50 10^4 TCID 50 10^5 TCID 50 10^6 TCID 50 10^7 TCID 50
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/5 (20.00%)   1/4 (25.00%)   0/5 (0.00%)   8/19 (42.11%)   7/15 (46.67%) 
Eye disorders           
Photophobia  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Gastrointestinal disorders           
Abdominal distension  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Aphthous stomatitis  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Constipation  1  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  0/15 (0.00%) 
Stomatitis  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Vomiting  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Injury, poisoning and procedural complications           
Fall  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Investigations           
Blood bilirubin increased  1  0/5 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/19 (0.00%)  0/15 (0.00%) 
Blood creatine phosphokinase  1  0/5 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/19 (0.00%)  2/15 (13.33%) 
Blood creatine phosphokinase increased  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/19 (10.53%)  0/15 (0.00%) 
Blood urea increased  1  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  0/15 (0.00%) 
Haemoglobin decreased  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Neutrophil count decreased  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/19 (10.53%)  0/15 (0.00%) 
Metabolism and nutrition disorders           
Hyperkalaemia  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Hypocalcaemia  1  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/5 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/19 (0.00%)  0/15 (0.00%) 
Musculoskeletal disorder  1  1/5 (20.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  0/15 (0.00%) 
Nervous system disorders           
Dizziness  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Presyncope  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders           
Urinary tract pain  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/19 (5.26%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Epistaxis  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders           
Rash  1  0/5 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/19 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matthew J. Memoli
Organization: National Institute of Allergy and Infectious Diseases
Phone: +1 301 443 5971
EMail: memolim@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01646138    
Other Study ID Numbers: 120077
12-I-0077 ( Other Identifier: NIH - National Institute of Allergy and Infectious Diseases )
First Submitted: July 18, 2012
First Posted: July 20, 2012
Results First Submitted: July 2, 2015
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016