Trial Outcomes & Findings for Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People (NCT NCT01971255)

NCT ID: NCT01971255

Last Updated: 2017-04-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Within 10 days of inoculation

Results posted on

2017-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	High Titer (HAI > 1:40) Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of =1:40 were assigned to this group.	Low Titer (HAI < 1:40) Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of \<1:40 were assigned to this group.
Overall Study STARTED	32	42
Overall Study COMPLETED	31	40
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Titer (HAI > 1:40) n=32 Participants Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 at the time of planned inoculation were placed in this group.	Low Titer (HAI < 1:40) n=42 Participants Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of \<1:40 at the time of planned inoculation and were placed in this group.	Total n=74 Participants Total of all reporting groups
Age, Categorical LTE18	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical BTWN	32 Participants n=5 Participants	41 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical GTE65	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	38 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Hawaiian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black	12 Participants n=5 Participants	20 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 10 days of inoculation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	High Titer (HAI > 1:40) n=25 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.	Low Titer (HAI < 1:40) n=40 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of \<1:40 were assigned to this group.
Number of Patients With Mild to Moderate Influenza Disease (MMID)	6 participants	29 participants

SECONDARY outcome

Timeframe: Within 28 days after inoculation

Population: 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.)

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.

Outcome measures

Outcome measures
Measure	High Titer (HAI > 1:40) n=25 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.	Low Titer (HAI < 1:40) n=40 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of \<1:40 were assigned to this group.
Clinical Disease Severity Score	18 units on a scale Interval 6.0 to 34.0	21 units on a scale Interval 8.0 to 88.0

SECONDARY outcome

Timeframe: Within 14 days of inoculation

The number of days total from the time a participant had the first positive test for influenza to their last positive test.

Outcome measures

Outcome measures
Measure	High Titer (HAI > 1:40) n=25 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.	Low Titer (HAI < 1:40) n=40 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of \<1:40 were assigned to this group.
Duration of Shedding (Days)	0 Days Interval 0.0 to 1.0	2 Days Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: within 68 days after inoculation

The number of days a participant experienced any influenza symptoms

Outcome measures

Outcome measures
Measure	High Titer (HAI > 1:40) n=25 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.	Low Titer (HAI < 1:40) n=40 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of \<1:40 were assigned to this group.
Duration of Symptoms (Days)	4 Days Interval 2.0 to 5.0	5.5 Days Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: within 68 days after inoculation

A simple count of the number of unique influenza symptoms the participant experienced.

Outcome measures

Outcome measures
Measure	High Titer (HAI > 1:40) n=25 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.	Low Titer (HAI < 1:40) n=40 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of \<1:40 were assigned to this group.
Number of Symptoms	2 Number Interval 1.0 to 4.0	4.5 Number Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: within 68 days after inoculation

This was determined by the presence or absence of influenza symptoms.

Outcome measures

Outcome measures
Measure	High Titer (HAI > 1:40) n=25 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.	Low Titer (HAI < 1:40) n=40 Participants Subjects with prechallenge hemagglutination inhibition (HAI) titers of \<1:40 were assigned to this group.
Number of Participants With Influenza Symptoms	20 participants	35 participants

Adverse Events

High Titer (HAI > 1:40)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Low Titer (HAI < 1:40)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	High Titer (HAI > 1:40) n=25 participants at risk Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.	Low Titer (HAI < 1:40) n=40 participants at risk Subjects with prechallenge hemagglutination inhibition (HAI) titers of \<1:40 were assigned to this group.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/25	2.5% 1/40
Ear and labyrinth disorders Ear discomfort	0.00% 0/25	2.5% 1/40
Gastrointestinal disorders Oral disorder	4.0% 1/25	0.00% 0/40
Gastrointestinal disorders Tooth disorder	4.0% 1/25	0.00% 0/40
Infections and infestations Platelet Count Decreased	4.0% 1/25	0.00% 0/40
Infections and infestations Viral infection	4.0% 1/25	0.00% 0/40
Injury, poisoning and procedural complications Laceration	4.0% 1/25	0.00% 0/40
Investigations Blood bilirubin increased	4.0% 1/25	0.00% 0/40
Investigations Blood creatine phosphokinase	8.0% 2/25	0.00% 0/40
Investigations Blood sodium increased	4.0% 1/25	0.00% 0/40
Investigations Blood thyroid stimulating hormone abnormal	0.00% 0/25	2.5% 1/40
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/25	2.5% 1/40
Nervous system disorders Migraine	0.00% 0/25	2.5% 1/40
Respiratory, thoracic and mediastinal disorders Dysphonia	4.0% 1/25	0.00% 0/40
Skin and subcutaneous tissue disorders Rash pruritic	8.0% 2/25	0.00% 0/40

Additional Information

Matthew James Memoli

National Institute of Allergy and Infectious Diseases

Phone: +1 301 443 5971

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place