Trial Outcomes & Findings for Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model (NCT NCT02525055)

NCT ID: NCT02525055

Last Updated: 2020-01-27

Results Overview

Area under the curve (AUC) of the Challenge Viral load, measured by nasopharyngeal swab quantitative polymerase chain reaction \[qPCR\], from Day 1 to Day 8 post-Viral Challenge. Nasopharyngeal swabs are collected up to 3 times per day ( every 8 hours +/- 30mins)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: 8 days
• Results posted on: 2020-01-27

Participant Flow

Participant milestones

Measure	Infectious Titre 1 Infectious titre 1: 6 subjects aged 18 to 45 received 1mL containing 2.8 x 10\*3 TCID50 Infectious titre 1: 2.8 x 10\*3 TCID50/mL	Infectious Titre 2 Infectious titre 2: 6 subjects aged 18 to 45 received 1mL containing 2.5 x 10\*4 TCID50 Infectious titre 2: 2.5 x 10\*4 TCID50/mL	Infectious Titre 3 Infectious titre 3: 6 subjects aged 18 to 45 received 1mL containing 3.6 x 10\*5 TCID50 Infectious titre 3: 3.6 x 10\*5 TCID50/mL	Infectious Titre 4 Infectious titre 4: 6 subjects aged 18 to 45 received 1mL containing 4.7 x 10\*6 TCID50 Infectious titre 4: 4.7 x 10\*6 TCID50/mL	Infectious Titre 5 (18 to 45 Years Old) Infectious titre 5: 6 subjects aged 18 to 45 received 1mL containing 3.5 x 10\*5 TCID50 Infectious titre 5: 3.5 x 10\*5 TCID50/mL	Infectious Titre 5 (46 to 64 Years Old) Infectious titre 5: 16 subjects aged 46 to 64 received 1mL containing 3.5 x 10\*5 TCID50 Infectious titre 5: 3.5 x 10\*5 TCID50/mL
Overall Study STARTED	6	6	6	6	6	16
Overall Study COMPLETED	6	6	6	6	6	16
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model

Baseline characteristics by cohort

Measure	Infectious Titre 1 n=6 Participants 6 participants aged 18 to 45 inoculated with 1mL containing 2.8 x 10\*3 TCID50	Infectious Titre 2 n=6 Participants 6 participants aged 18 to 45 inoculated with 1mL containing 2.5 x 10\*4 TCID50	Infectious Titre 3 n=6 Participants 6 participants aged 18 to 45 inoculated with 1mL containing 3.6 x 10\*5 TCID50	Infectious Titre 4 n=6 Participants 6 participants aged 18 to 45 inoculated with 1mL containing 4.7 x 10\*6 TCID50	Infectious Titre 5 (18 to 45 Years Old) n=6 Participants 6 participants aged 18 to 45 inoculated with 1mL containing 3.5 x 10\*5 TCID50	Infectious Titre 5 (46 to 64 Years Old) n=16 Participants 16 participants aged 46 to 64 inoculated with 1mL containing 3.5 x 10\*5 TCID50	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	6 Participants n=36 Participants	16 Participants n=10 Participants	46 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants	2 Participants n=36 Participants	5 Participants n=10 Participants	17 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	3 Participants n=483 Participants	4 Participants n=36 Participants	11 Participants n=10 Participants	29 Participants n=115 Participants
Region of Enrollment United Kingdom	6 participants n=93 Participants	6 participants n=4 Participants	6 participants n=27 Participants	6 participants n=483 Participants	6 participants n=36 Participants	16 participants n=10 Participants	46 participants n=115 Participants

PRIMARY outcome

Timeframe: 8 days

Area under the curve (AUC) of the Challenge Viral load, measured by nasopharyngeal swab quantitative polymerase chain reaction [qPCR], from Day 1 to Day 8 post-Viral Challenge. Nasopharyngeal swabs are collected up to 3 times per day ( every 8 hours +/- 30mins)

Outcome measures

Measure	Infectious Titre 1 n=6 Participants Participants aged 18 to 45 received 1mL containing 2.8 x 10\*3 TCID50	Infectious Titre 2 n=6 Participants Participants aged 18 to 45 received 1mL containing 2.5 x 10\*4 TCID50	Infectious Titre 3 n=6 Participants Participants aged 18 to 45 received 1mL containing 3.6 x 10\*5 TCID50	Infectious Titre 4 n=6 Participants Participants aged 18 to 45 received 1mL containing 4.7 x 10\*6 TCID50	Infectious Titre 5 (18 to 45 Years Old) n=6 Participants Participants aged 18 to 45 received 1mL containing 3.5 x 10\*5 TCID50	Infectious Titre 5 (46 to 64 Years Old) n=16 Participants Participants aged 46 to 64 received 1mL containing 3.5 x 10\*5 TCID50
Area Under the Curve of Virus Load	-2081.98 mins*Eq log10 TCID50/mL Standard Deviation 869.61	18,973.90 mins*Eq log10 TCID50/mL Standard Deviation 1048.23	15,944.09 mins*Eq log10 TCID50/mL Standard Deviation 13751.39	12,201.14 mins*Eq log10 TCID50/mL Standard Deviation 8877.43	9563.26 mins*Eq log10 TCID50/mL Standard Deviation 10,536.96	11,710.28 mins*Eq log10 TCID50/mL Standard Deviation 11833.87

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 days

Outcome measures

Outcome data not reported

Adverse Events

Infectious Titre 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Infectious Titre 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Infectious Titre 3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Infectious Titre 4

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Infectious Titre 5 (Aged 18 to 45)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Infectious Titre 5 (Aged 45 to 64)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Infectious Titre 1 n=6 participants at risk Infectious titre 1: 6 participants aged 18 to 45 were inoculated with 1mL containing 2.8 x 10\*3 TCID50 Infectious titre 1: 2.8 x 10\*3 TCID50/mL	Infectious Titre 2 n=6 participants at risk Infectious titre 2: 6 participants aged 18 to 45 were inoculated with 1mL containing 2.5 x 10\*4 TCID50 Infectious titre 2: 2.5 x 10\*4 TCID50/mL	Infectious Titre 3 n=6 participants at risk Infectious titre 3: 6 participants aged 18 to 45 were inoculated with 1mL containing 3.6 x 10\*5 TCID50 Infectious titre 3: 3.6 x 10\*5 TCID50/mL	Infectious Titre 4 n=6 participants at risk Infectious titre 4: 6 participants aged 18 to 45 were inoculated with 1mL containing 4.7 x 10\*6 TCID50 Infectious titre 4: 4.7 x 10\*6 TCID50/mL	Infectious Titre 5 (Aged 18 to 45) n=6 participants at risk 6 participants aged 18 to 45 were inoculated with 1mL containing 3.5 x 10\*5 TCID50 Infectious titre 5: 3.5 x 10\*5 TCID50/mL	Infectious Titre 5 (Aged 45 to 64) n=16 participants at risk 16 participants aged 46 to 64 were inoculated with 1mL containing 3.5 x 10\*5 TCID50 Infectious titre 5: 3.5 x 10\*5 TCID50/mL
Cardiac disorders Tachycardia	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	12.5% 2/16 • Number of events 2 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Gastrointestinal disorders Toothache	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/16 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Gastrointestinal disorders Haemorrhoidal	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Gastrointestinal disorders Mouth ulceration	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Immune system disorders Seasonal allergy	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/16 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Infections and infestations Rash pustular	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/16 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Infections and infestations Candida infection	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Injury, poisoning and procedural complications Procedural haemorrhage	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	50.0% 3/6 • Number of events 3 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	12.5% 2/16 • Number of events 2 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations Spirometry abnormal	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/16 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations ALT increased	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/16 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations AST increased	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations Blood glucose increased	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations Blood pressure increased	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations C-reactive protein increased	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	18.8% 3/16 • Number of events 3 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations Lymphocyte count decreased	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations Reticulocyte count increased	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Investigations Vital capacity decreased	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Nervous system disorders Headache	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	12.5% 2/16 • Number of events 2 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/16 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	16.7% 1/6 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/16 • Adverse events are collected throughout the study from screening to last study visit (108 days)
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	0.00% 0/6 • Adverse events are collected throughout the study from screening to last study visit (108 days)	6.2% 1/16 • Number of events 1 • Adverse events are collected throughout the study from screening to last study visit (108 days)

Additional Information

Dr Nicolas Noulin

hVIVO Services Limeted

Phone: +442077561365

Email: n.noulin@hvivo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place