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Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People

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ClinicalTrials.gov Identifier: NCT01971255
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
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: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Influenza
Intervention Biological: Ca/04/2009/H1N1r Challenge Virus
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Hide Arm/Group Description Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of =1:40 were assigned to this group. Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of <1:40 were assigned to this group.
Period Title: Overall Study
Started 32 42
Completed 31 40
Not Completed 1 2
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40) Total
Hide Arm/Group Description Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 at the time of planned inoculation were placed in this group. Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 at the time of planned inoculation and were placed in this group. Total of all reporting groups
Overall Number of Baseline Participants 32 42 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 42 participants 74 participants
LTE18
0
   0.0%
1
   2.4%
1
   1.4%
BTWN
32
 100.0%
41
  97.6%
73
  98.6%
GTE65
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 42 participants 74 participants
Female
16
  50.0%
20
  47.6%
36
  48.6%
Male
16
  50.0%
22
  52.4%
38
  51.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 42 participants 74 participants
Hispanic
4
  12.5%
3
   7.1%
7
   9.5%
Not Hispanic or Latino
27
  84.4%
38
  90.5%
65
  87.8%
Unknown or Not Reported
1
   3.1%
1
   2.4%
2
   2.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 42 participants 74 participants
American Indian or Alaska Native
1
   3.1%
0
   0.0%
1
   1.4%
Asian
2
   6.3%
3
   7.1%
5
   6.8%
Hawaiian
0
   0.0%
0
   0.0%
0
   0.0%
Black
12
  37.5%
20
  47.6%
32
  43.2%
White
17
  53.1%
19
  45.2%
36
  48.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Patients With Mild to Moderate Influenza Disease (MMID)
Hide Description This was determined by presence of the combination of symptoms of influenza and presence of a positive clinical test for influenza. If both were present then the participant had positive MMID.
Time Frame Within 10 days of inoculation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included only those subjects who received the influenza challenge virus and were not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.) In addition this represents the number of people who were high or low titer at the time of challenge with influenza virus not at screening.
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Hide Arm/Group Description:
Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
Overall Number of Participants Analyzed 25 40
Measure Type: Number
Unit of Measure: participants
6 29
2.Secondary Outcome
Title Clinical Disease Severity Score
Hide Description This was measured using a validated participant directed questionnaire called FLUPRO. This is then scored daily with a range of score from 0-185. The total score is the sum of all time points the questionnaire is given, which is 16 time points. Therefore the total score range is from 0-2960. 0 would represent no symptoms over the 16 time points while 2960 would represent maximum symptoms and perceived severity at all 16 time points.
Time Frame Within 28 days after inoculation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Hide Arm/Group Description:
Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
Overall Number of Participants Analyzed 25 40
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
18
(6 to 34)
21
(8 to 88)
3.Secondary Outcome
Title Duration of Shedding (Days)
Hide Description The number of days total from the time a participant had the first positive test for influenza to their last positive test.
Time Frame Within 14 days of inoculation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Hide Arm/Group Description:
Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
Overall Number of Participants Analyzed 25 40
Median (Inter-Quartile Range)
Unit of Measure: Days
0
(0 to 1)
2
(1 to 5)
4.Secondary Outcome
Title Duration of Symptoms (Days)
Hide Description The number of days a participant experienced any influenza symptoms
Time Frame within 68 days after inoculation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Hide Arm/Group Description:
Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
Overall Number of Participants Analyzed 25 40
Median (Inter-Quartile Range)
Unit of Measure: Days
4
(2 to 5)
5.5
(3 to 8)
5.Secondary Outcome
Title Number of Symptoms
Hide Description A simple count of the number of unique influenza symptoms the participant experienced.
Time Frame within 68 days after inoculation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Hide Arm/Group Description:
Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
Overall Number of Participants Analyzed 25 40
Median (Inter-Quartile Range)
Unit of Measure: Number
2
(1 to 4)
4.5
(2 to 8)
6.Secondary Outcome
Title Number of Participants With Influenza Symptoms
Time Frame within 68 days after inoculation
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Hide Arm/Group Description:
Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
Overall Number of Participants Analyzed 25 40
Measure Type: Number
Unit of Measure: participants
20 35
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Hide Arm/Group Description Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group. Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
All-Cause Mortality
High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Titer (HAI > 1:40) Low Titer (HAI < 1:40)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/25 (40.00%)   4/40 (10.00%) 
Blood and lymphatic system disorders     
Lymphadenopathy   0/25 (0.00%)  1/40 (2.50%) 
Ear and labyrinth disorders     
Ear discomfort   0/25 (0.00%)  1/40 (2.50%) 
Gastrointestinal disorders     
Oral disorder   1/25 (4.00%)  0/40 (0.00%) 
Tooth disorder   1/25 (4.00%)  0/40 (0.00%) 
Infections and infestations     
Platelet Count Decreased   1/25 (4.00%)  0/40 (0.00%) 
Viral infection   1/25 (4.00%)  0/40 (0.00%) 
Injury, poisoning and procedural complications     
Laceration   1/25 (4.00%)  0/40 (0.00%) 
Investigations     
Blood bilirubin increased   1/25 (4.00%)  0/40 (0.00%) 
Blood creatine phosphokinase   2/25 (8.00%)  0/40 (0.00%) 
Blood sodium increased   1/25 (4.00%)  0/40 (0.00%) 
Blood thyroid stimulating hormone abnormal   0/25 (0.00%)  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders     
Back pain   0/25 (0.00%)  1/40 (2.50%) 
Nervous system disorders     
Migraine   0/25 (0.00%)  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia   1/25 (4.00%)  0/40 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash pruritic   2/25 (8.00%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
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 James 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: NCT01971255     History of Changes
Other Study ID Numbers: 130215
13-I-0215 ( Other Identifier: United States: The National Institutes of Health )
First Submitted: October 23, 2013
First Posted: October 29, 2013
Results First Submitted: October 20, 2016
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017