Healthy
Conditions
Brief summary
The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose of 1\*10\^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash viral load compared to placebo.
Interventions
BIOLOGICALAd26.RSV.preF
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\*10\^11 vp in single-use vials.
DRUGPlacebo
Placebo will be administered as sterile 0.9% saline for injection.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, is willing to be isolated and stay in the clinic for the quarantine phase, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol * Participants must be in good health, without significant medical illness, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and weight), skin examination, medical history, vital signs (systolic and diastolic blood pressure and heart rate, respiratory rate, and body temperature), and the results of clinical laboratory tests performed within 56 days of vaccination. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator * Participants must have a non-clinically significant 12-lead electrocardiogram (ECG) within 56 days of vaccination including: normal sinus rhythm (heart rate between 50 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) interval less than or equal to (\<=) 450 millisecond (ms); QT interval corrected for heart rate according to Bazett (QTcB) interval \<= 450 ms; QRS interval less than (\<) 120 ms; PR interval \<= 210 ms * Participants must be sero-suitable for respiratory syncytial virus (RSV) within 90 days of vaccination (low immunity to the RSV-A Memphis 37b virus using a virus neutralization assay * Participant must be healthy on the basis of clinical laboratory tests performed within 56 days of vaccination. If the results of the laboratory screening tests are outside the local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the US Food and Drug Administration (FDA) toxicity tables (that is, for tests in the FDA table), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Exclusion criteria
* Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (\>=) 37.8 degree Centigrade within 24 hours prior to study vaccination * Participant has history of malignancy (exceptions are basal cell carcinomas of the skin treated over 5 years prior to vaccination considered cured with minimal risk of recurrence) * Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively Viral Challenge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | From Day 2 to Day 12 | VL-AUC for RSV was determined by qRT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours) | Viral load determined by quantitative RT-PCR assay of nasal wash samples on Day 6 and Day 7 were reported. Here, values below the lower limit of quantification (LLOQ) were imputed with zero. |
| VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours) | VL-AUC of RSV by the quantitative culture of nasal wash samples on Day 6 and Day 7 were determined. pfu\*h/mL stands for plaque-forming units hour per millilitre. |
| Percentage of Participants With Symptomatic RSV Infections | From Day 2 to Day 12 | Symptomatic RSV infection is defined in two ways (Conservative and Liberal). Conservative: participant had 2 or more quantifiable RT-PCR measurements on different samples, with one of following: symptoms of 2 different categories of subject symptom card (SSC) (Upper Respiratory \[runny/stuffy nose, sneezing, sore throat, earache\], Lower Respiratory \[cough, shortness of breath, chest tightness, wheeze\], Systemic \[malaise, headache, muscle and/or joint ache\]) regardless of grade and assessment timepoint or Grade 2 symptom from any category; Liberal (RT-PCR): had 2/more quantifiable RT-PCR measurements, with clinical symptom of any severity. |
| Total Clinical Symptoms Score at Day 6 and 7 | Day 6 and 7: morning, afternoon and evening | The total clinical symptom score was determined as the sum of the scores (grades) ranges from 0 (no symptom) to 52 (severe symptoms) of the 13 self-reportable symptoms on the SSC. Clinical symptoms includes runny nose, stuffy nose, sneezing, sore throat, ear ache, malaise, headache, muscle and/or joint ache, chilliness/ feverishness, cough, chest tightness, shortness of breath and wheeze. For every separate symptom, the score ranges from 0 (I have no symptom) to 4 (its quite bothersome most of the times and stop from participating in activities). |
| Weight of Mucus Secretions Over Time | Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | The weight mucous over time was determined in grams using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the weight of mucus from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily mucus weight. |
| Number of Tissues Used Over Time | Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | Number of tissues used by participant per time point were reported using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the number of tissues used from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily number of tissues used. |
| Peak Viral Load of RSV-A Memphis 37b | From Day 2 to Day 12 | Peak viral load of RSV-A Memphis 37b was defined as the maximum viral load as determined by quantitative RT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero. |
| Percentage of Participants With Serious Adverse Events (SAEs) | Up to 6 months post-vaccination and up to 6 months post-challenge | A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With Solicited Local and Systemic AEs | 7 days post-vaccination (Day -21) | Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. |
| Percentage of Participants With Vital Signs Abnormalities | Up to Day 28 post-challenge | Percentage of participants with vital signs abnormalities were reported. Vital signs measurements included body temperature (measured in degree celsius from less than \[\<\] 37.5 to \<39.5), respiratory rate, systolic and diastolic blood pressure, and pulse rate, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). |
| Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Up to Day 12 post challenge | ECG parameters included heart rate, PR, QRS, QTcB, QTcF, and the uncorrected QT interval which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). |
| Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Up to Day 28 post-challenge | Percentage of participants with clinical laboratory abnormalities were reported. The biochemical and hematological parameters analyzed were- Alanine aminotransferase (AA), Alkaline phosphatase (AP), Aspartate aminotransferase (AsP), Hyperkalemia, Hypernatremia, Hypoglycemia, Hypophosphatemia, Hemoglobin, Neutrophils, White blood cell (WBC) - increase and Urine protein, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). |
| Percentage of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post-vaccination and up to 28 days post-challenge | Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. |
Countries
United Kingdom
Participant flow
Pre-assignment details
In total, 64 participants were screened. Of these, 63 participants were randomized and received the study vaccine. One participant was randomized in error and did not receive the study vaccine hence not included in the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Ad26.RSV.preF (1*10^11 vp) Participants received a single intramuscular injection of 1\*10\^11 vp (viral particles) of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination). | 31 |
| Placebo Participants received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0 (24 to 90 days after vaccination). | 32 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Ad26.RSV.preF (1*10^11 vp) | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 25.9 years STANDARD_DEVIATION 6.19 | 25.9 years STANDARD_DEVIATION 6.33 | 25.9 years STANDARD_DEVIATION 6.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 62 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 24 Participants | 52 Participants | 28 Participants |
| Region of Enrollment UNITED KINGDOM | 31 Participants | 63 Participants | 32 Participants |
| Sex: Female, Male Female | 12 Participants | 18 Participants | 6 Participants |
| Sex: Female, Male Male | 19 Participants | 45 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 4 / 31 | 9 / 32 | 16 / 27 | 16 / 26 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 | 1 / 27 | 0 / 26 |
Outcome results
Primary
Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)
VL-AUC for RSV was determined by qRT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.
Time frame: From Day 2 to Day 12
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | 0 log10 copies*hour per millilitre (h/mL) |
| Placebo | Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | 236 log10 copies*hour per millilitre (h/mL) |
p-value: 0.012Wilcoxon Rank Sum test
Secondary
Number of Tissues Used Over Time
Number of tissues used by participant per time point were reported using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the number of tissues used from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily number of tissues used.
Time frame: Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 2 | 2.9 Tissues | Standard Error 0.65 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 7 | 2.8 Tissues | Standard Error 0.92 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 4 | 2.3 Tissues | Standard Error 0.49 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 8 | 2.0 Tissues | Standard Error 0.71 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 1 | 1.7 Tissues | Standard Error 0.41 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 9 | 2.3 Tissues | Standard Error 0.72 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 5 | 2.1 Tissues | Standard Error 0.81 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 10 | 1.8 Tissues | Standard Error 0.61 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 3 | 1.9 Tissues | Standard Error 0.45 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 11 | 1.6 Tissues | Standard Error 0.47 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 6 | 2.4 Tissues | Standard Error 0.77 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 12 | 1.4 Tissues | Standard Error 0.4 |
| Ad26.RSV.preF (1*10^11 vp) | Number of Tissues Used Over Time | Day 0 | 1.8 Tissues | Standard Error 0.53 |
| Placebo | Number of Tissues Used Over Time | Day 12 | 1.7 Tissues | Standard Error 0.45 |
| Placebo | Number of Tissues Used Over Time | Day 0 | 0.7 Tissues | Standard Error 0.33 |
| Placebo | Number of Tissues Used Over Time | Day 1 | 0.7 Tissues | Standard Error 0.27 |
| Placebo | Number of Tissues Used Over Time | Day 2 | 1.2 Tissues | Standard Error 0.32 |
| Placebo | Number of Tissues Used Over Time | Day 3 | 1.3 Tissues | Standard Error 0.28 |
| Placebo | Number of Tissues Used Over Time | Day 4 | 1.5 Tissues | Standard Error 0.31 |
| Placebo | Number of Tissues Used Over Time | Day 5 | 2.3 Tissues | Standard Error 0.68 |
| Placebo | Number of Tissues Used Over Time | Day 6 | 5.1 Tissues | Standard Error 1.59 |
| Placebo | Number of Tissues Used Over Time | Day 7 | 8.1 Tissues | Standard Error 1.94 |
| Placebo | Number of Tissues Used Over Time | Day 8 | 5.2 Tissues | Standard Error 1.38 |
| Placebo | Number of Tissues Used Over Time | Day 9 | 2.8 Tissues | Standard Error 0.53 |
| Placebo | Number of Tissues Used Over Time | Day 10 | 2.7 Tissues | Standard Error 0.61 |
| Placebo | Number of Tissues Used Over Time | Day 11 | 2.0 Tissues | Standard Error 0.5 |
Secondary
Peak Viral Load of RSV-A Memphis 37b
Peak viral load of RSV-A Memphis 37b was defined as the maximum viral load as determined by quantitative RT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.
Time frame: From Day 2 to Day 12
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Peak Viral Load of RSV-A Memphis 37b | 0.000 log10 copies per mL |
| Placebo | Peak Viral Load of RSV-A Memphis 37b | 5.365 log10 copies per mL |
Secondary
Percentage of Participants With Clinical Laboratory Abnormalities (Graded)
Percentage of participants with clinical laboratory abnormalities were reported. The biochemical and hematological parameters analyzed were- Alanine aminotransferase (AA), Alkaline phosphatase (AP), Aspartate aminotransferase (AsP), Hyperkalemia, Hypernatremia, Hypoglycemia, Hypophosphatemia, Hemoglobin, Neutrophils, White blood cell (WBC) - increase and Urine protein, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).
Time frame: Up to Day 28 post-challenge
Population: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) signifies the number of participants analyzed for this OM at specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AsA: Grade 1 | 14.8 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AsA: Grade 2 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AsA: Grade 4 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Bilirubin: Grade 2 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hyperglycemia: Grade 1 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hyperkalemia: Grade 1 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hypernatremia: Grade 2 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hypophosphatemia:Grade 1 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hypoproteinemia:Grade 1 | 11.1 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Eosinophils: Grade 1 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hemoglobin: Grade 1 | 7.4 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Neutrophils: Grade 1 | 7.4 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Platelets: Grade 1 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Platelets: Grade 20 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: WBC increase: Grade 1 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Neutrophils: Grade 1 | 12.9 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Urine Protein: Grade 1 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: AA: Grade 1 | 9.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: AP: Grade 1 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: AsA: Grade 1 | 6.5 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: AsA: Grade 2 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hyperkalemia: Grade 2 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hypernatremia: Grade 2 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hypoglycemia: Grade 2 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hypophosphatemia:Grade 1 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hypophosphatemia:Grade 2 | 9.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hemoglobin: Grade 1 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hemoglobin: Grade 2 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: WBC increase: Grade 1 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AA: Grade 1 | 25.9 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AA: Grade 2 | 7.4 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AP: Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hypophosphatemia:Grade 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: AA: Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AsA: Grade 2 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AA: Grade 1 | 15.4 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AsA: Grade 4 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: AP: Grade 1 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Bilirubin: Grade 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hemoglobin: Grade 1 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hyperglycemia: Grade 1 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: AsA: Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hyperkalemia: Grade 1 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AP: Grade 1 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hypernatremia: Grade 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: AsA: Grade 2 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hypophosphatemia:Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hemoglobin: Grade 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hypoproteinemia:Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hyperkalemia: Grade 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Eosinophils: Grade 1 | 7.7 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Neutrophils: Grade 1 | 6.3 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Hemoglobin: Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hypernatremia: Grade 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Neutrophils: Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AA: Grade 2 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Platelets: Grade 1 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hypoglycemia: Grade 2 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: Platelets: Grade 20 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: WBC increase: Grade 1 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: WBC increase: Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Hypophosphatemia:Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Challenge: AsA: Grade 1 | 15.4 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Laboratory Abnormalities (Graded) | Post Dose: Urine Protein: Grade 1 | 3.1 Percentage of participants |
Secondary
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
ECG parameters included heart rate, PR, QRS, QTcB, QTcF, and the uncorrected QT interval which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).
Time frame: Up to Day 12 post challenge
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTc Fridericia: (increase from baseline [30; 60] ms) | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart rate: Abnormally low: Grade 1 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart rate: Abnormally low: Grade 2 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTc Bazett (450 millisecond [ms], 480 ms) | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTc Bazett (increase from baseline [30; 60] ms) | 7.4 Percentage of participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTc Bazett (increase from baseline [30; 60] ms) | 11.5 Percentage of participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTc Bazett (450 millisecond [ms], 480 ms) | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart rate: Abnormally low: Grade 1 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | QTc Fridericia: (increase from baseline [30; 60] ms) | 0 Percentage of participants |
| Placebo | Percentage of Participants With Electrocardiogram (ECG) Abnormalities | Heart rate: Abnormally low: Grade 2 | 3.8 Percentage of participants |
Secondary
Percentage of Participants With Serious Adverse Events (SAEs)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to 6 months post-vaccination and up to 6 months post-challenge
Population: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable participants who were analyzed at specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Serious Adverse Events (SAEs) | Post-vaccination | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Serious Adverse Events (SAEs) | Post-challenge | 3.2 Percentage of participants |
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) | Post-vaccination | 0 Percentage of participants |
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) | Post-challenge | 0 Percentage of participants |
Secondary
Percentage of Participants With Solicited Local and Systemic AEs
Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever.
Time frame: 7 days post-vaccination (Day -21)
Population: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Solicited Local and Systemic AEs | Solicited local AEs | 100.0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Solicited Local and Systemic AEs | Solicited systemic AEs | 100.0 Percentage of participants |
| Placebo | Percentage of Participants With Solicited Local and Systemic AEs | Solicited local AEs | 18.8 Percentage of participants |
| Placebo | Percentage of Participants With Solicited Local and Systemic AEs | Solicited systemic AEs | 50.0 Percentage of participants |
Secondary
Percentage of Participants With Symptomatic RSV Infections
Symptomatic RSV infection is defined in two ways (Conservative and Liberal). Conservative: participant had 2 or more quantifiable RT-PCR measurements on different samples, with one of following: symptoms of 2 different categories of subject symptom card (SSC) (Upper Respiratory \[runny/stuffy nose, sneezing, sore throat, earache\], Lower Respiratory \[cough, shortness of breath, chest tightness, wheeze\], Systemic \[malaise, headache, muscle and/or joint ache\]) regardless of grade and assessment timepoint or Grade 2 symptom from any category; Liberal (RT-PCR): had 2/more quantifiable RT-PCR measurements, with clinical symptom of any severity.
Time frame: From Day 2 to Day 12
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Symptomatic RSV Infections | Conservative | 22.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Symptomatic RSV Infections | Liberal | 33.3 Percentage of participants |
| Placebo | Percentage of Participants With Symptomatic RSV Infections | Conservative | 46.2 Percentage of participants |
| Placebo | Percentage of Participants With Symptomatic RSV Infections | Liberal | 61.5 Percentage of participants |
Secondary
Percentage of Participants With Unsolicited Adverse Events (AEs)
Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product.
Time frame: Up to 28 days post-vaccination and up to 28 days post-challenge
Population: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable participants who were analyzed at specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Unsolicited Adverse Events (AEs) | Post-vaccination | 35.5 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Unsolicited Adverse Events (AEs) | Post-challenge | 74.1 Percentage of participants |
| Placebo | Percentage of Participants With Unsolicited Adverse Events (AEs) | Post-vaccination | 46.9 Percentage of participants |
| Placebo | Percentage of Participants With Unsolicited Adverse Events (AEs) | Post-challenge | 69.2 Percentage of participants |
Secondary
Percentage of Participants With Vital Signs Abnormalities
Percentage of participants with vital signs abnormalities were reported. Vital signs measurements included body temperature (measured in degree celsius from less than \[\<\] 37.5 to \<39.5), respiratory rate, systolic and diastolic blood pressure, and pulse rate, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).
Time frame: Up to Day 28 post-challenge
Population: The Full Analysis Set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable participants who were analyzed at specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Bradycardia (pulse): Grade 2 | 6.5 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Respiratory rate: Grade 1 | 25.8 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Temperature (38.5-<39.0) | 6.5 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Tachycardia (pulse): Grade 1 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Bradycardia (pulse): Grade 3/4 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Bradycardia (pulse): Grade 1 | 18.5 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Temperature (38.0-<38.5) | 6.5 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Bradycardia (pulse): Grade 2 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Hypertension (diastolic): Grade 1 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Bradycardia (pulse): Grade 3/4 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Bradycardia (pulse): Grade 1 | 12.9 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Hypertension (diastolic): Grade 1 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Hypertension (diastolic): Grade 2 | 6.5 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Hypertension (systolic): Grade 1 | 0 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Temperature (37.5-<38.0) | 22.6 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Respiratory rate: Grade 1 | 25.9 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Hypertension (systolic): Grade 1 | 3.2 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Tachycardia (pulse): Grade 1 | 3.7 Percentage of participants |
| Ad26.RSV.preF (1*10^11 vp) | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Temperature (<37.5) | 64.5 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Tachycardia (pulse): Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Temperature (<37.5) | 93.8 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Temperature (37.5-<38.0) | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Temperature (38.0-<38.5) | 0 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Temperature (38.5-<39.0) | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Bradycardia (pulse): Grade 1 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Bradycardia (pulse): Grade 2 | 6.3 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Bradycardia (pulse): Grade 3/4 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Hypertension (diastolic): Grade 1 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Hypertension (diastolic): Grade 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Hypertension (systolic): Grade 1 | 3.1 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Respiratory rate: Grade 1 | 18.8 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-dose: Tachycardia (pulse): Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Bradycardia (pulse): Grade 1 | 11.5 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Bradycardia (pulse): Grade 2 | 3.8 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Bradycardia (pulse): Grade 3/4 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Hypertension (diastolic): Grade 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Hypertension (systolic): Grade 1 | 7.7 Percentage of participants |
| Placebo | Percentage of Participants With Vital Signs Abnormalities | Post-challenge: Respiratory rate: Grade 1 | 26.9 Percentage of participants |
Secondary
Total Clinical Symptoms Score at Day 6 and 7
The total clinical symptom score was determined as the sum of the scores (grades) ranges from 0 (no symptom) to 52 (severe symptoms) of the 13 self-reportable symptoms on the SSC. Clinical symptoms includes runny nose, stuffy nose, sneezing, sore throat, ear ache, malaise, headache, muscle and/or joint ache, chilliness/ feverishness, cough, chest tightness, shortness of breath and wheeze. For every separate symptom, the score ranges from 0 (I have no symptom) to 4 (its quite bothersome most of the times and stop from participating in activities).
Time frame: Day 6 and 7: morning, afternoon and evening
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Total Clinical Symptoms Score at Day 6 and 7 | Day 6: Morning | 0.6 Units on a scale | Standard Error 0.18 |
| Ad26.RSV.preF (1*10^11 vp) | Total Clinical Symptoms Score at Day 6 and 7 | Day 6: Afternoon | 0.4 Units on a scale | Standard Error 0.18 |
| Ad26.RSV.preF (1*10^11 vp) | Total Clinical Symptoms Score at Day 6 and 7 | Day 6: Evening | 0.5 Units on a scale | Standard Error 0.28 |
| Ad26.RSV.preF (1*10^11 vp) | Total Clinical Symptoms Score at Day 6 and 7 | Day 7: Morning | 0.6 Units on a scale | Standard Error 0.23 |
| Ad26.RSV.preF (1*10^11 vp) | Total Clinical Symptoms Score at Day 6 and 7 | Day 7: Afternoon | 0.6 Units on a scale | Standard Error 0.32 |
| Ad26.RSV.preF (1*10^11 vp) | Total Clinical Symptoms Score at Day 6 and 7 | Day 7: Evening | 0.6 Units on a scale | Standard Error 0.32 |
| Placebo | Total Clinical Symptoms Score at Day 6 and 7 | Day 7: Afternoon | 2.5 Units on a scale | Standard Error 0.7 |
| Placebo | Total Clinical Symptoms Score at Day 6 and 7 | Day 6: Morning | 2.6 Units on a scale | Standard Error 0.64 |
| Placebo | Total Clinical Symptoms Score at Day 6 and 7 | Day 7: Morning | 2.5 Units on a scale | Standard Error 0.7 |
| Placebo | Total Clinical Symptoms Score at Day 6 and 7 | Day 6: Afternoon | 2.8 Units on a scale | Standard Error 0.74 |
| Placebo | Total Clinical Symptoms Score at Day 6 and 7 | Day 7: Evening | 2.5 Units on a scale | Standard Error 0.63 |
| Placebo | Total Clinical Symptoms Score at Day 6 and 7 | Day 6: Evening | 2.5 Units on a scale | Standard Error 0.65 |
Secondary
Viral Load by Quantitative RT-PCR Assay on Day 6 and 7
Viral load determined by quantitative RT-PCR assay of nasal wash samples on Day 6 and Day 7 were reported. Here, values below the lower limit of quantification (LLOQ) were imputed with zero.
Time frame: Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants. Here 'n' (number analyzed) signifies the number of participants analyzed for this outcome measure (OM) at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 6: 0 hour | 0.821 log10 copies per mL | Standard Error 0.349 |
| Ad26.RSV.preF (1*10^11 vp) | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 6: 12 hour | 1.261 log10 copies per mL | Standard Error 0.433 |
| Ad26.RSV.preF (1*10^11 vp) | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 7: 0 hour | 1.761 log10 copies per mL | Standard Error 0.436 |
| Ad26.RSV.preF (1*10^11 vp) | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 7: 12 hour | 1.552 log10 copies per mL | Standard Error 0.443 |
| Placebo | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 7: 12 hour | 3.025 log10 copies per mL | Standard Error 0.53 |
| Placebo | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 6: 0 hour | 2.898 log10 copies per mL | Standard Error 0.63 |
| Placebo | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 7: 0 hour | 3.072 log10 copies per mL | Standard Error 0.586 |
| Placebo | Viral Load by Quantitative RT-PCR Assay on Day 6 and 7 | Day 6: 12 hour | 2.939 log10 copies per mL | Standard Error 0.604 |
Secondary
VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7
VL-AUC of RSV by the quantitative culture of nasal wash samples on Day 6 and Day 7 were determined. pfu\*h/mL stands for plaque-forming units hour per millilitre.
Time frame: Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants. Here 'n' (number analyzed) signifies the number of participants analyzed for this OM at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 6: 0 hour | 0.278 log10 pfu*h/mL | Standard Error 0.1936 |
| Ad26.RSV.preF (1*10^11 vp) | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 6: 12 hour | 0.304 log10 pfu*h/mL | Standard Error 0.2198 |
| Ad26.RSV.preF (1*10^11 vp) | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 7: 0 hour | 0.101 log10 pfu*h/mL | Standard Error 0.1015 |
| Ad26.RSV.preF (1*10^11 vp) | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 7: 12 hour | 0.276 log10 pfu*h/mL | Standard Error 0.1931 |
| Placebo | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 7: 12 hour | 1.237 log10 pfu*h/mL | Standard Error 0.3891 |
| Placebo | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 6: 0 hour | 1.587 log10 pfu*h/mL | Standard Error 0.4159 |
| Placebo | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 7: 0 hour | 1.226 log10 pfu*h/mL | Standard Error 0.3505 |
| Placebo | VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7 | Day 6: 12 hour | 1.737 log10 pfu*h/mL | Standard Error 0.432 |
Secondary
Weight of Mucus Secretions Over Time
The weight mucous over time was determined in grams using eCRF forms. Participants were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the participants should store them in an airtight plastic bag to calculate the weight of mucus from Day 0 to Day 12. All paper tissues used by each participant were collected for each 24-hour period up to Day 12, to determine daily mucus weight.
Time frame: Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Population: The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all participants who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged participants. Here 'n' (number analyzed) signifies the number of participants analyzed for this OM at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 2 | 0.997 Grams | Standard Error 0.235 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 7 | 1.715 Grams | Standard Error 0.7201 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 4 | 1.164 Grams | Standard Error 0.3535 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 8 | 0.799 Grams | Standard Error 0.296 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 1 | 0.228 Grams | Standard Error 0.0621 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 9 | 1.004 Grams | Standard Error 0.4147 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 5 | 1.440 Grams | Standard Error 0.8609 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 10 | 0.907 Grams | Standard Error 0.3457 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 3 | 0.970 Grams | Standard Error 0.2176 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 11 | 0.749 Grams | Standard Error 0.243 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 6 | 1.226 Grams | Standard Error 0.4925 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 12 | 0.622 Grams | Standard Error 0.2647 |
| Ad26.RSV.preF (1*10^11 vp) | Weight of Mucus Secretions Over Time | Day 0 | 0.586 Grams | Standard Error 0.1883 |
| Placebo | Weight of Mucus Secretions Over Time | Day 12 | 0.990 Grams | Standard Error 0.3005 |
| Placebo | Weight of Mucus Secretions Over Time | Day 0 | 0.175 Grams | Standard Error 0.0913 |
| Placebo | Weight of Mucus Secretions Over Time | Day 1 | 0.086 Grams | Standard Error 0.0333 |
| Placebo | Weight of Mucus Secretions Over Time | Day 2 | 0.428 Grams | Standard Error 0.1459 |
| Placebo | Weight of Mucus Secretions Over Time | Day 3 | 0.543 Grams | Standard Error 0.1333 |
| Placebo | Weight of Mucus Secretions Over Time | Day 4 | 0.714 Grams | Standard Error 0.2123 |
| Placebo | Weight of Mucus Secretions Over Time | Day 5 | 1.068 Grams | Standard Error 0.3539 |
| Placebo | Weight of Mucus Secretions Over Time | Day 6 | 3.132 Grams | Standard Error 1.0991 |
| Placebo | Weight of Mucus Secretions Over Time | Day 7 | 5.124 Grams | Standard Error 1.3257 |
| Placebo | Weight of Mucus Secretions Over Time | Day 8 | 3.230 Grams | Standard Error 1.1022 |
| Placebo | Weight of Mucus Secretions Over Time | Day 9 | 1.798 Grams | Standard Error 0.4406 |
| Placebo | Weight of Mucus Secretions Over Time | Day 10 | 1.785 Grams | Standard Error 0.4838 |
| Placebo | Weight of Mucus Secretions Over Time | Day 11 | 1.172 Grams | Standard Error 0.3442 |