Trial Outcomes & Findings for Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model (NCT NCT03180801)
NCT ID: NCT03180801
Last Updated: 2020-08-05
Results Overview
To determine the effect of FLU-v on reducing the incidence of Mild to Moderate Influenza Disease (MMID) defined as detectable viral shedding by Luminex Respiratory Pathogen Panel Test (RPP) in the presence of at least one influenza symptom.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
From 24h post-viral inoculation (Day 1) until the end of the quarantine phase on Day 7
Results posted on
2020-08-05
Participant Flow
An excess number of subjects were vaccinated to ensure 123 subjects were able to complete the quarantine period . Any subject that dropped out after vaccination but before inoculation with the challenge virus was replaced with another vaccinated subject.
Participant milestones
| Measure |
Group 1 Adjuvanted Placebo
0.5ml adjuvanted placebo (Montanide ISA-51: WFI) on Day -43 and on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
|
Group 2 Adjuvanted FLU-v One Dose
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
|
Group 3 Adjuvanted FLU-v Two Doses
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
51
|
|
Overall Study
Safety Population
|
50
|
52
|
51
|
|
Overall Study
Intention to Treat
|
42
|
40
|
41
|
|
Overall Study
COMPLETED
|
42
|
40
|
41
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
10
|
Reasons for withdrawal
| Measure |
Group 1 Adjuvanted Placebo
0.5ml adjuvanted placebo (Montanide ISA-51: WFI) on Day -43 and on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
|
Group 2 Adjuvanted FLU-v One Dose
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
|
Group 3 Adjuvanted FLU-v Two Doses
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 as subcutaneous injection followed by H1N1 influenza challenge on day 0.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
3
|
3
|
1
|
|
Overall Study
Non-compliance
|
1
|
4
|
0
|
|
Overall Study
Inoculation Target Reached
|
1
|
1
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
3
|
Baseline Characteristics
Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model
Baseline characteristics by cohort
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
adjuvanted placebo on Day -43 and on Day -22 followed
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
500mcg adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
500mcg adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.8 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian/Asian British
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black/Black British
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Chinese
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Japanese
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
41 participants
n=5 Participants
|
123 participants
n=4 Participants
|
|
Number of subjects with challenge strain HAI titers > or = 40 at screening
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From 24h post-viral inoculation (Day 1) until the end of the quarantine phase on Day 7Population: ITT includes those participants who received both vaccination and were challenged with the H1N1 influenza virus
To determine the effect of FLU-v on reducing the incidence of Mild to Moderate Influenza Disease (MMID) defined as detectable viral shedding by Luminex Respiratory Pathogen Panel Test (RPP) in the presence of at least one influenza symptom.
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Number of Participants With Mild to Moderate Influenza Disease (MMID)
Negative MMID
|
19 Participants
|
27 Participants
|
26 Participants
|
|
Number of Participants With Mild to Moderate Influenza Disease (MMID)
positive MMID
|
23 Participants
|
13 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: From the first vaccination on day -43 to the last follow up visit on day 63.Population: Safety population
To determine the number of TEAEs that were reported after the first administration of the vaccine until the end of the study (overall) and then separated into pre-inoculation (events reported from the time of first vaccination up to Day 0 prior to time of inoculation) and post-inoculation (Day 0 inoculation time through study completion).
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=50 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=52 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=51 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) Per Subject.
Overall
|
1.86 Number of TEAEs per subject
Standard Error 0.26
|
1.38 Number of TEAEs per subject
Standard Error 0.24
|
2.35 Number of TEAEs per subject
Standard Error 0.27
|
|
Number of Treatment Emergent Adverse Events (TEAEs) Per Subject.
Pre-inoculation
|
1.00 Number of TEAEs per subject
Standard Error 0.21
|
0.81 Number of TEAEs per subject
Standard Error 0.13
|
1.51 Number of TEAEs per subject
Standard Error 0.19
|
|
Number of Treatment Emergent Adverse Events (TEAEs) Per Subject.
Post-Inoculation
|
0.86 Number of TEAEs per subject
Standard Error 0.16
|
0.58 Number of TEAEs per subject
Standard Error 0.15
|
0.84 Number of TEAEs per subject
Standard Error 0.16
|
PRIMARY outcome
Timeframe: From the day of the first vaccination up to the end of the study on day +63.Population: Safety population
Number of subjects with one or more AE are reported by severity (mild, moderate and severe) and relatedness to vaccine or challenge virus inoculation (definitely, probably, possibly, unlikely, not related).
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=50 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=52 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=51 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs definately related to vaccine
|
7 Number of participants
|
24 Number of participants
|
29 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects withTEAEs probably related to vaccine
|
1 Number of participants
|
0 Number of participants
|
6 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs possibly related to vaccine
|
3 Number of participants
|
2 Number of participants
|
3 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs not related to vaccine
|
37 Number of participants
|
21 Number of participants
|
34 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs definately related to virus
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs unlikely related to virus
|
7 Number of participants
|
0 Number of participants
|
6 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with Severe TEAEs
|
0 Number of participants
|
1 Number of participants
|
3 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with Serious Adverse Events (SAEs)
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs unlikely related to vaccine
|
11 Number of participants
|
4 Number of participants
|
9 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs probably related to virus
|
3 Number of participants
|
1 Number of participants
|
1 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs possibly related to virus
|
4 Number of participants
|
3 Number of participants
|
6 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with TEAEs not related to virus
|
37 Number of participants
|
32 Number of participants
|
44 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with mild TEAEs
|
37 Number of participants
|
33 Number of participants
|
42 Number of participants
|
|
Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Subjects with moderate TEAEs
|
13 Number of participants
|
4 Number of participants
|
11 Number of participants
|
SECONDARY outcome
Timeframe: Quarantine period from day 1 to day 7 post-inoculation.Population: ITT
Number of subjects experiencing at least one influenza symptom and at least two influenza symptoms. Number of subjects with detectable shedding by RPP (Luminex) test from nasal swabs. Number asymptomatic subjects with detectable virus by RPP (Luminex) test from nasal swabs.
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Number of Subjects With Detectable Viral Shedding and Number of Subjects With Recorded Influenza Symptoms During the Quarantine Period.
Subjects with at least one symptom
|
37 Participants
|
34 Participants
|
30 Participants
|
|
Number of Subjects With Detectable Viral Shedding and Number of Subjects With Recorded Influenza Symptoms During the Quarantine Period.
Subjects with detectable shedding
|
23 Participants
|
15 Participants
|
18 Participants
|
|
Number of Subjects With Detectable Viral Shedding and Number of Subjects With Recorded Influenza Symptoms During the Quarantine Period.
Asymptomatic subjects with detectable shedding
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Detectable Viral Shedding and Number of Subjects With Recorded Influenza Symptoms During the Quarantine Period.
Subjects with at least two symptoms
|
27 Participants
|
16 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: starting from evening of Day 1 post-inoculation up to Day 7.Population: ITT
Number of days with detectable viral shedding measured using the Luminex Respiratory Pathogen Panel test.
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Viral Shedding Duration
|
1.95 days
Standard Error 0.36
|
1.20 days
Standard Error 0.31
|
1.90 days
Standard Error 0.39
|
SECONDARY outcome
Timeframe: from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)Population: ITT
Shedding is quantified by RT-PCR from nasal swabs taken twice daily (am/pm) during the quarantine period. Plotting the log copy number/ml for each time point against time is done to calculate the area under the curve (AUC) using the trapezoidal rule.
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Total Viral Shedding (Area Under the Curve)
|
153.67 hours*log10copy number/ml
Standard Error 33.39
|
98.47 hours*log10copy number/ml
Standard Error 27.39
|
138.79 hours*log10copy number/ml
Standard Error 31.73
|
SECONDARY outcome
Timeframe: from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)Population: ITT
Shedding is quantified by RT-PCR from nasal swabs taken twice daily (am/pm) during the quarantine period. Peak viral load is the highest recorded log10copy number/ml.
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Peak Viral Load
|
2.24 log10copy number/ml
Standard Error 0.40
|
1.54 log10copy number/ml
Standard Error 0.39
|
2.28 log10copy number/ml
Standard Error 0.42
|
SECONDARY outcome
Timeframe: from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)Population: ITT
Subjects were assessed by the physician whilst under quarantine post-inoculation. The number of days subjects experienced influenza symptoms was recorded.
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Duration of Influenza Symptoms
|
3.26 days
Standard Error 0.37
|
2.67 days
Standard Error 0.35
|
2.76 days
Standard Error 0.37
|
SECONDARY outcome
Timeframe: from the evening of Day 1 post-inoculation to the morning until the day of last symptom noted during the expected quarantine period (up tp Day 7)Population: ITT
Mean of total number of symptoms (upper and lower respiratory and systemic symptoms) experienced calculated as the total sum of symptoms experienced divided by the number of days in which symptoms were collected.
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Number of Symptoms Experienced Per Subject Per Day.
|
2.57 number of symptoms per day
Standard Error 0.33
|
2.08 number of symptoms per day
Standard Error 0.32
|
2.51 number of symptoms per day
Standard Error 0.41
|
SECONDARY outcome
Timeframe: from the evening of Day 1 post-inoculation until the day of last symptom noted during the expected quarantine period (up to Day 7).Population: ITT
The highest level of the total sum of all upper and lower respiratory tract and systemic symptoms recorded on any day starting from the evening of Day 1 post-inoculation until the day of last symptom noted during the expected quarantine period (up to Day 7).
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Peak Number of Symptoms Experienced Per Subject in a Single Day.
|
2.12 number of symptoms
Standard Error 0.26
|
1.68 number of symptoms
Standard Error 0.22
|
1.88 number of symptoms
Standard Error 0.28
|
SECONDARY outcome
Timeframe: from Day 1 post-inoculation until the day 7.Population: ITT
FLU-PRO assesses 32 influenza symptoms. Subjects rate each symptom on a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. For 27 of the items, the scale is as follows: 0 ("Not at all"), 1 ("A little bit"), 2 ("Somewhat"), 3 ("Quite a bit"), and 4 ("Very much"). For 5 items, severity is assessed in terms of numerical frequency, i.e., vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing, and coughed up mucus or phlegm evaluated on a scale from 0 ("Never") to 4 ("Always").The FLU-PRO total score is computed as a mean score across all 32 items comprising the instrument. Total scores can range from 0 (symptom free) to 4 (very severe symptoms).
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=42 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=41 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Assessment of Self-reported Influenza Symptoms by FLU-PRO Questionnaire.
|
0.05 FLU-PRO total score
Standard Error 0.01
|
0.03 FLU-PRO total score
Standard Error 0.01
|
0.04 FLU-PRO total score
Standard Error 0.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At pre-inoculation post-vaccination (Day -2), and post-influenza challenge (Day 35/Day 63)Population: Subjects that received vaccination, underwent influenza challenge and provided serum samples.
To determine the antibody responses specific to FLU-v.
Outcome measures
| Measure |
Group 1 Adjuvanted Placebo
n=41 Participants
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=40 Participants
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Immunogenicity of FLU-v
Day -2
|
5.94 ng/ml
Standard Error 0.99
|
72.17 ng/ml
Standard Error 6.28
|
75.74 ng/ml
Standard Error 5.50
|
|
Immunogenicity of FLU-v
Day 35
|
6.09 ng/ml
Standard Error 0.93
|
66.86 ng/ml
Standard Error 6.07
|
73.55 ng/ml
Standard Error 5.69
|
|
Immunogenicity of FLU-v
Day 63
|
6.26 ng/ml
Standard Error 1.06
|
60.33 ng/ml
Standard Error 5.81
|
67.90 ng/ml
Standard Error 5.35
|
Adverse Events
Group 1 Adjuvanted Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Group 2 Adjuvanted FLU-v One Dose
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Group 3 Adjuvanted FLU-v Two Doses
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Adjuvanted Placebo
n=50 participants at risk
0.5ml adjuvanted placebo on Day -43 and on Day -22
|
Group 2 Adjuvanted FLU-v One Dose
n=52 participants at risk
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
|
Group 3 Adjuvanted FLU-v Two Doses
n=51 participants at risk
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/50 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.9%
3/51 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
3/50 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
1.9%
1/52 • Number of events 1 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
2.0%
1/51 • Number of events 1 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.9%
3/51 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/50 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.9%
3/51 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
General disorders
Injection site induration
|
18.0%
9/50 • Number of events 9 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
46.2%
24/52 • Number of events 24 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
60.8%
31/51 • Number of events 31 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
General disorders
Injection site pain
|
0.00%
0/50 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
1.9%
1/52 • Number of events 1 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.9%
3/51 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.9%
3/51 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Infections and infestations
Nasopharyngitis
|
12.0%
6/50 • Number of events 6 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.9%
3/51 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Infections and infestations
Oral Herpes
|
2.0%
1/50 • Number of events 1 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
1.9%
1/52 • Number of events 1 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.9%
3/51 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.0%
14/50 • Number of events 14 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
17.3%
9/52 • Number of events 9 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
15.7%
8/51 • Number of events 8 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Injury, poisoning and procedural complications
Laceration
|
4.0%
2/50 • Number of events 2 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/51 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
3/50 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
3.9%
2/51 • Number of events 2 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Investigations
Aspartate aminotransferase increased
|
6.0%
3/50 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
3.9%
2/51 • Number of events 2 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Investigations
Neutrophil count decreased
|
4.0%
2/50 • Number of events 2 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/52 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/51 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/50 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.8%
3/52 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/51 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • Number of events 4 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
3.8%
2/52 • Number of events 2 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
3.9%
2/51 • Number of events 2 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Nervous system disorders
Headache
|
22.0%
11/50 • Number of events 11 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
9.6%
5/52 • Number of events 5 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
25.5%
13/51 • Number of events 13 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.0%
3/50 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
3.8%
2/52 • Number of events 2 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
2.0%
1/51 • Number of events 1 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
5.8%
3/52 • Number of events 3 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
0.00%
0/51 • From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Treatment Emergent AEs are all AEs that occur in the period between the first administration of the vaccine and the end of the study independently of their intensity and if they are related or not to the vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI requires the Sponsor's consent to publish any material that contains Sponsor Property; including Study Data.
- Publication restrictions are in place
Restriction type: OTHER