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Trial record 2 of 4 for:    flu-v | influenza

Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180801
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : May 1, 2019
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
PepTcell Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: adjuvanted FLU-v
Biological: adjuvanted placebo
Other: Influenza challenge
Enrollment 153
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 50 52 51
Safety Population [1] 50 52 51
Intention to Treat [2] 42 40 41
Completed 42 40 41
Not Completed 8 12 10
Reason Not Completed
Physician Decision             3             3             1
Non-compliance             1             4             0
Inoculation Target Reached             1             1             3
Adverse Event             1             0             2
Withdrawal by Subject             2             2             1
Lost to Follow-up             0             2             3
[1]
The safety population included all vaccinated subjects
[2]
ITT included all vaccinated and inoculated subjects
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses Total
Hide Arm/Group Description adjuvanted placebo on Day -43 and on Day -22 followed 500mcg adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 500mcg adjuvanted FLU-v vaccine on Day -43 and on Day -22 Total of all reporting groups
Overall Number of Baseline Participants 42 40 41 123
Hide Baseline Analysis Population Description
The Intention to treat (ITT) group was used for all analysis. ITT includes those participants who received both vaccination and challenge with an influenza virus.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 40 participants 41 participants 123 participants
28.8  (7.5) 29.9  (8.9) 27.4  (9.2) 28.7  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 41 participants 123 participants
Female
13
  31.0%
12
  30.0%
11
  26.8%
36
  29.3%
Male
29
  69.0%
28
  70.0%
30
  73.2%
87
  70.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 42 participants 40 participants 41 participants 123 participants
White
33
  78.6%
37
  92.5%
34
  82.9%
104
  84.6%
Asian/Asian British
1
   2.4%
0
   0.0%
1
   2.4%
2
   1.6%
Black/Black British
3
   7.1%
0
   0.0%
2
   4.9%
5
   4.1%
Chinese
0
   0.0%
1
   2.5%
0
   0.0%
1
   0.8%
Hispanic
0
   0.0%
1
   2.5%
0
   0.0%
1
   0.8%
Japanese
1
   2.4%
0
   0.0%
0
   0.0%
1
   0.8%
Mixed
4
   9.5%
0
   0.0%
3
   7.3%
7
   5.7%
Other
0
   0.0%
1
   2.5%
1
   2.4%
2
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 42 participants 40 participants 41 participants 123 participants
42 40 41 123
Number of subjects with challenge strain HAI titers > or = 40 at screening  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 41 participants 123 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Mild to Moderate Influenza Disease (MMID)
Hide Description 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.
Time Frame From 24h post-viral inoculation (Day 1) until the end of the quarantine phase on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
ITT includes those participants who received both vaccination and were challenged with the H1N1 influenza virus
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
Overall Number of Participants Analyzed 42 40 41
Measure Type: Count of Participants
Unit of Measure: Participants
positive MMID
23
  54.8%
13
  32.5%
15
  36.6%
Negative MMID
19
  45.2%
27
  67.5%
26
  63.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Number of Treatment Emergent Adverse Events (TEAEs) Per Subject.
Hide Description 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).
Time Frame From the first vaccination on day -43 to the last follow up visit on day 63.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
Overall Number of Participants Analyzed 50 52 51
Mean (Standard Error)
Unit of Measure: Number of TEAEs per subject
Overall 1.86  (0.26) 1.38  (0.24) 2.35  (0.27)
Pre-inoculation 1.00  (0.21) 0.81  (0.13) 1.51  (0.19)
Post-Inoculation 0.86  (0.16) 0.58  (0.15) 0.84  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One sided Fisher's exact test is used to test if the TEAE rates pre-inoculation recorded for the treatment group are higher than for placebo.
Type of Statistical Test Other
Comments One sided Fisher's exact test is used to test if TEAE rates of vaccine group is higher than the placebo group.
Statistical Test of Hypothesis P-Value 0.647
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Fisher's exact test is used to test if TEAE rate of vaccine group recorded pre-inoculation is higher than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0240
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.
Hide Description 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).
Time Frame From the day of the first vaccination up to the end of the study on day +63.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
Overall Number of Participants Analyzed 50 52 51
Measure Type: Number
Unit of Measure: Number of participants
Subjects with TEAEs definately related to vaccine 7 24 29
Subjects withTEAEs probably related to vaccine 1 0 6
Subjects with TEAEs possibly related to vaccine 3 2 3
Subjects with TEAEs unlikely related to vaccine 11 4 9
Subjects with TEAEs not related to vaccine 37 21 34
Subjects with TEAEs definately related to virus 1 0 0
Subjects with TEAEs probably related to virus 3 1 1
Subjects with TEAEs possibly related to virus 4 3 6
Subjects with TEAEs unlikely related to virus 7 0 6
Subjects with TEAEs not related to virus 37 32 44
Subjects with mild TEAEs 37 33 42
Subjects with moderate TEAEs 13 4 11
Subjects with Severe TEAEs 0 1 3
Subjects with Serious Adverse Events (SAEs) 0 0 0
4.Secondary Outcome
Title Number of Subjects With Detectable Viral Shedding and Number of Subjects With Recorded Influenza Symptoms During the Quarantine Period.
Hide Description

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.

Time Frame Quarantine period from day 1 to day 7 post-inoculation.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
Overall Number of Participants Analyzed 42 40 41
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with at least one symptom
37
  88.1%
34
  85.0%
30
  73.2%
Subjects with at least two symptoms
27
  64.3%
16
  40.0%
23
  56.1%
Subjects with detectable shedding
23
  54.8%
15
  37.5%
18
  43.9%
Asymptomatic subjects with detectable shedding
0
   0.0%
2
   5.0%
3
   7.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.465
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.230
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Viral Shedding Duration
Hide Description Number of days with detectable viral shedding measured using the Luminex Respiratory Pathogen Panel test.
Time Frame starting from evening of Day 1 post-inoculation up to Day 7.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
Overall Number of Participants Analyzed 42 40 41
Mean (Standard Error)
Unit of Measure: days
1.95  (0.36) 1.20  (0.31) 1.90  (0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0501
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3139
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Total Viral Shedding (Area Under the Curve)
Hide Description 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.
Time Frame from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
Overall Number of Participants Analyzed 42 40 41
Mean (Standard Error)
Unit of Measure: hours*log10copy number/ml
153.67  (33.39) 98.47  (27.39) 138.79  (31.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Wilcoxon test is used to test if vaccine group has smaller shedding AUC than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Wilcoxon test is used to test if vaccine group has a smaller shedding AUC than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.481
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Peak Viral Load
Hide Description 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.
Time Frame from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
Overall Number of Participants Analyzed 42 40 41
Mean (Standard Error)
Unit of Measure: log10copy number/ml
2.24  (0.40) 1.54  (0.39) 2.28  (0.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.601
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Duration of Influenza Symptoms
Hide Description Subjects were assessed by the physician whilst under quarantine post-inoculation. The number of days subjects experienced influenza symptoms was recorded.
Time Frame from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
Overall Number of Participants Analyzed 42 40 41
Mean (Standard Error)
Unit of Measure: days
3.26  (0.37) 2.67  (0.35) 2.76  (0.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Number of Symptoms Experienced Per Subject Per Day.
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
Overall Number of Participants Analyzed 42 40 41
Mean (Standard Error)
Unit of Measure: number of symptoms per day
2.57  (0.33) 2.08  (0.32) 2.51  (0.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Peak Number of Symptoms Experienced Per Subject in a Single Day.
Hide Description 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).
Time Frame from the evening of Day 1 post-inoculation until the day of last symptom noted during the expected quarantine period (up to Day 7).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
Overall Number of Participants Analyzed 42 40 41
Mean (Standard Error)
Unit of Measure: number of symptoms
2.12  (0.26) 1.68  (0.22) 1.88  (0.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.178
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Assessment of Self-reported Influenza Symptoms by FLU-PRO Questionnaire.
Hide Description 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).
Time Frame from Day 1 post-inoculation until the day 7.
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Hide Analysis Population Description
ITT
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
Overall Number of Participants Analyzed 42 40 41
Mean (Standard Error)
Unit of Measure: FLU-PRO total score
0.05  (0.01) 0.03  (0.01) 0.04  (0.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.201
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Other Pre-specified Outcome
Title Immunogenicity of FLU-v
Hide Description To determine the antibody responses specific to FLU-v.
Time Frame At pre-inoculation post-vaccination (Day -2), and post-influenza challenge (Day 35/Day 63)
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Hide Analysis Population Description
Subjects that received vaccination, underwent influenza challenge and provided serum samples.
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description:
0.5ml adjuvanted placebo on Day -43 and on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 followed by influenza challenge on day 0
0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22 followed by influenza challenge on day 0
Overall Number of Participants Analyzed 41 40 40
Mean (Standard Error)
Unit of Measure: ng/ml
Day -2 5.94  (0.99) 72.17  (6.28) 75.74  (5.50)
Day 35 6.09  (0.93) 66.86  (6.07) 73.55  (5.69)
Day 63 6.26  (1.06) 60.33  (5.81) 67.90  (5.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments comparison on day -2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments Comparion on day -2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments Comparison on day 35
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments Comparison on day 35
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 2 Adjuvanted FLU-v One Dose
Comments Comparison on day 63
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group 1 Adjuvanted Placebo, Group 3 Adjuvanted FLU-v Two Doses
Comments Comparison on day 63
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame From the date of first administration of vaccine to the date of inoculation with the challenge virus (TEAEs).
Adverse Event Reporting Description 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.
 
Arm/Group Title Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Hide Arm/Group Description 0.5ml adjuvanted placebo on Day -43 and on Day -22 0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and adjuvanted placebo on Day -22 0.5ml (500mcg) adjuvanted FLU-v vaccine on Day -43 and on Day -22
All-Cause Mortality
Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/52 (0.00%)      0/51 (0.00%)    
Hide Serious Adverse Events
Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/52 (0.00%)      0/51 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Group 1 Adjuvanted Placebo Group 2 Adjuvanted FLU-v One Dose Group 3 Adjuvanted FLU-v Two Doses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/50 (54.00%)      33/52 (63.46%)      45/51 (88.24%)    
Blood and lymphatic system disorders       
Neutropenia  1  0/50 (0.00%)  0 0/52 (0.00%)  0 3/51 (5.88%)  3
Gastrointestinal disorders       
Diarrhoea  1  3/50 (6.00%)  3 1/52 (1.92%)  1 1/51 (1.96%)  1
Nausea  1  1/50 (2.00%)  1 0/52 (0.00%)  0 3/51 (5.88%)  3
Toothache  1  0/50 (0.00%)  0 0/52 (0.00%)  0 3/51 (5.88%)  3
General disorders       
Injection site induration  1  9/50 (18.00%)  9 24/52 (46.15%)  24 31/51 (60.78%)  31
Injection site pain  1  0/50 (0.00%)  0 1/52 (1.92%)  1 3/51 (5.88%)  3
Infections and infestations       
Gastroenteritis  1  0/50 (0.00%)  0 0/52 (0.00%)  0 3/51 (5.88%)  3
Nasopharyngitis  1  6/50 (12.00%)  6 0/52 (0.00%)  0 3/51 (5.88%)  3
Oral Herpes  1  1/50 (2.00%)  1 1/52 (1.92%)  1 3/51 (5.88%)  3
Upper respiratory tract infection  1  14/50 (28.00%)  14 9/52 (17.31%)  9 8/51 (15.69%)  8
Injury, poisoning and procedural complications       
Laceration  1  2/50 (4.00%)  2 0/52 (0.00%)  0 0/51 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  3/50 (6.00%)  3 0/52 (0.00%)  0 2/51 (3.92%)  2
Aspartate aminotransferase increased  1  3/50 (6.00%)  3 0/52 (0.00%)  0 2/51 (3.92%)  2
Neutrophil count decreased  1  2/50 (4.00%)  2 0/52 (0.00%)  0 0/51 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Myalgia  1  0/50 (0.00%)  0 3/52 (5.77%)  3 0/51 (0.00%)  0
Nervous system disorders       
Dizziness * 1  4/50 (8.00%)  4 2/52 (3.85%)  2 2/51 (3.92%)  2
Headache  1  11/50 (22.00%)  11 5/52 (9.62%)  5 13/51 (25.49%)  13
Reproductive system and breast disorders       
Dysmenorrhoea  1  3/50 (6.00%)  3 2/52 (3.85%)  2 1/51 (1.96%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/50 (0.00%)  0 3/52 (5.77%)  3 0/51 (0.00%)  0
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI requires the Sponsor's consent to publish any material that contains Sponsor Property; including Study Data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Olga Pleguezuelos
Organization: SEEK
Phone: +44 020 7153 6601
EMail: olga.pleguezuelos@seekacure.com
Publications:
Layout table for additonal information
Responsible Party: PepTcell Limited
ClinicalTrials.gov Identifier: NCT03180801    
Other Study ID Numbers: FLU-v-004
2016-002134-74 ( EudraCT Number )
2015-25472 ( Other Identifier: CRADA between NIAID-NIH and PepTcell )
First Submitted: May 31, 2017
First Posted: June 8, 2017
Results First Submitted: March 20, 2019
Results First Posted: May 1, 2019
Last Update Posted: August 5, 2020