A Phase 2 interventional study of Ad26.RSV.preF and Placebo in Healthy, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 2, Interventional, and Prevention
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.
Janssen Vaccines & Prevention B.V. is the lead sponsor of 49 studies on the registry; none are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 32 (86%) have results posted.
First submitted after Janssen Vaccines & Prevention B.V. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Viral Challenge Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive single intramuscular injection of 1\*10\^11 virus particles (vp) of Ad26.RSV.preF during Day -90 to Day -28. On Day 0, intranasal challenge with respiratory syncytial virus (RSV)-A Memphis 37b virus will occur for all participants.
Biological: Ad26.RSV.preF
Participants will receive single intramuscular injection of placebo as sterile 0.9 percent (%) saline for injection during Day -90 to Day -28. On Day 0, intranasal challenge with RSV-A Memphis 37b virus will occur for all participants.
Drug: Placebo
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\*10\^11 vp in single-use vials.
Also known as: JNJ-64400141
Placebo will be administered as sterile 0.9% saline for injection.
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
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
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)
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)
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
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
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
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
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
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
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)
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
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
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
| Milestone | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Started | 31 | 32 |
| Completed | 27 | 26 |
| Not completed | 4 | 6 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Withdrew: Physician decision | 1 | 2 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| log10 copies*hour per millilitre (h/mL) | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Area Under the Viral Load-Time Curve (VL-AUC) of Respiratory Syncytial Virus (RSV) by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | 0 (0.0 to 268.8) | 236 (20.3 to 605.8) |
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.
| log10 copies per mL | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Peak Viral Load of RSV-A Memphis 37b | 0.000 (0.000 to 4.539) | 5.365 (3.027 to 6.665) |
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.
| log10 copies per mL | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Day 6: 0 hour | 0.821 ± 0.349 | 2.898 ± 0.630 |
| Day 6: 12 hour | 1.261 ± 0.433 | 2.939 ± 0.604 |
| Day 7: 0 hour | 1.761 ± 0.436 | 3.072 ± 0.586 |
| Day 7: 12 hour | 1.552 ± 0.443 | 3.025 ± 0.530 |
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.
| log10 pfu*h/mL | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Day 6: 0 hour | 0.278 ± 0.1936 | 1.587 ± 0.4159 |
| Day 6: 12 hour | 0.304 ± 0.2198 | 1.737 ± 0.4320 |
| Day 7: 0 hour | 0.101 ± 0.1015 | 1.226 ± 0.3505 |
| Day 7: 12 hour | 0.276 ± 0.1931 | 1.237 ± 0.3891 |
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.
| Percentage of participants | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Conservative | 22.2 | 46.2 |
| Liberal | 33.3 | 61.5 |
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).
| Units on a scale | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Day 6: Morning | 0.6 ± 0.18 | 2.6 ± 0.64 |
| Day 6: Afternoon | 0.4 ± 0.18 | 2.8 ± 0.74 |
| Day 6: Evening | 0.5 ± 0.28 | 2.5 ± 0.65 |
| Day 7: Morning | 0.6 ± 0.23 | 2.5 ± 0.70 |
| Day 7: Afternoon | 0.6 ± 0.32 | 2.5 ± 0.70 |
| Day 7: Evening | 0.6 ± 0.32 | 2.5 ± 0.63 |
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.
| Grams | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Day 0 | 0.586 ± 0.1883 | 0.175 ± 0.0913 |
| Day 1 | 0.228 ± 0.0621 | 0.086 ± 0.0333 |
| Day 2 | 0.997 ± 0.2350 | 0.428 ± 0.1459 |
| Day 3 | 0.970 ± 0.2176 | 0.543 ± 0.1333 |
| Day 4 | 1.164 ± 0.3535 | 0.714 ± 0.2123 |
| Day 5 | 1.440 ± 0.8609 | 1.068 ± 0.3539 |
| Day 6 | 1.226 ± 0.4925 | 3.132 ± 1.0991 |
| Day 7 | 1.715 ± 0.7201 | 5.124 ± 1.3257 |
| Day 8 | 0.799 ± 0.2960 | 3.230 ± 1.1022 |
| Day 9 | 1.004 ± 0.4147 | 1.798 ± 0.4406 |
| Day 10 | 0.907 ± 0.3457 | 1.785 ± 0.4838 |
| Day 11 | 0.749 ± 0.2430 | 1.172 ± 0.3442 |
| Day 12 | 0.622 ± 0.2647 | 0.990 ± 0.3005 |
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.
| Tissues | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Day 0 | 1.8 ± 0.53 | 0.7 ± 0.33 |
| Day 1 | 1.7 ± 0.41 | 0.7 ± 0.27 |
| Day 2 | 2.9 ± 0.65 | 1.2 ± 0.32 |
| Day 3 | 1.9 ± 0.45 | 1.3 ± 0.28 |
| Day 4 | 2.3 ± 0.49 | 1.5 ± 0.31 |
| Day 5 | 2.1 ± 0.81 | 2.3 ± 0.68 |
| Day 6 | 2.4 ± 0.77 | 5.1 ± 1.59 |
| Day 7 | 2.8 ± 0.92 | 8.1 ± 1.94 |
| Day 8 | 2.0 ± 0.71 | 5.2 ± 1.38 |
| Day 9 | 2.3 ± 0.72 | 2.8 ± 0.53 |
| Day 10 | 1.8 ± 0.61 | 2.7 ± 0.61 |
| Day 11 | 1.6 ± 0.47 | 2.0 ± 0.50 |
| Day 12 | 1.4 ± 0.40 | 1.7 ± 0.45 |
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.
| Percentage of participants | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Post-vaccination | 35.5 | 46.9 |
| Post-challenge | 74.1 | 69.2 |
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 | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Post-vaccination | 0 | 0 |
| Post-challenge | 3.2 | 0 |
Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever.
| Percentage of participants | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Solicited local AEs | 100.0 | 18.8 |
| Solicited systemic AEs | 100.0 | 50.0 |
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 | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Post-dose: Temperature (<37.5) | 64.5 | 93.8 |
| Post-dose: Temperature (37.5-<38.0) | 22.6 | 3.1 |
| Post-dose: Temperature (38.0-<38.5) | 6.5 | 0 |
| Post-dose: Temperature (38.5-<39.0) | 6.5 | 3.1 |
| Post-dose: Bradycardia (pulse): Grade 1 | 12.9 | 3.1 |
| Post-dose: Bradycardia (pulse): Grade 2 | 6.5 | 6.3 |
| Post-dose: Bradycardia (pulse): Grade 3/4 | 3.2 | 0 |
| Post-dose: Hypertension (diastolic): Grade 1 | 0 | 3.1 |
| Post-dose: Hypertension (diastolic): Grade 2 | 6.5 | 0 |
| Post-dose: Hypertension (systolic): Grade 1 | 3.2 | 3.1 |
| Post-dose: Respiratory rate: Grade 1 | 25.8 | 18.8 |
| Post-dose: Tachycardia (pulse): Grade 1 | 3.2 | 0 |
| Post-challenge: Bradycardia (pulse): Grade 1 | 18.5 | 11.5 |
| Post-challenge: Bradycardia (pulse): Grade 2 | 3.7 | 3.8 |
| Post-challenge: Bradycardia (pulse): Grade 3/4 | 3.7 | 0 |
| Post-challenge: Hypertension (diastolic): Grade 1 | 3.7 | 0 |
| Post-challenge: Hypertension (systolic): Grade 1 | 0 | 7.7 |
| Post-challenge: Respiratory rate: Grade 1 | 25.9 | 26.9 |
| Post-challenge: Tachycardia (pulse): Grade 1 | 3.7 | 0 |
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 | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Heart rate: Abnormally low: Grade 1 | 0 | 3.8 |
| Heart rate: Abnormally low: Grade 2 | 0 | 3.8 |
| QTc Bazett (450 millisecond [ms], 480 ms) | 0 | 3.8 |
| QTc Bazett (increase from baseline [30; 60] ms) | 7.4 | 11.5 |
| QTc Fridericia: (increase from baseline [30; 60] ms) | 3.7 | 0 |
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 | Ad26.RSV.preF (1*10^11 vp) | Placebo |
|---|---|---|
| Post Dose: AA: Grade 1 | 9.7 | 0 |
| Post Dose: AP: Grade 1 | 0 | 3.1 |
| Post Dose: AsA: Grade 1 | 6.5 | 0 |
| Post Dose: AsA: Grade 2 | 0 | 3.1 |
| Post Dose: Hyperkalemia: Grade 2 | 3.2 | 0 |
| Post Dose: Hypernatremia: Grade 2 | 3.2 | 0 |
| Post Dose: Hypoglycemia: Grade 2 | 0 | 3.1 |
| Post Dose: Hypophosphatemia:Grade 1 | 3.2 | 0 |
| Post Dose: Hypophosphatemia:Grade 2 | 9.7 | 0 |
| Post Dose: Hemoglobin: Grade 1 | 3.2 | 3.1 |
| Post Dose: Hemoglobin: Grade 2 | 3.2 | 0 |
| Post Dose: Neutrophils: Grade 1 | 12.9 | 6.3 |
| Post Dose: WBC increase: Grade 1 | 0 | 3.1 |
| Post Dose: Urine Protein: Grade 1 | 3.2 | 3.1 |
| Post Challenge: AA: Grade 1 | 25.9 | 15.4 |
| Post Challenge: AA: Grade 2 | 7.4 | 3.8 |
| Post Challenge: AP: Grade 1 | 0 | 3.8 |
| Post Challenge: AsA: Grade 1 | 14.8 | 15.4 |
| Post Challenge: AsA: Grade 2 | 3.7 | 3.8 |
| Post Challenge: AsA: Grade 4 | 0 | 3.8 |
| Post Challenge: Bilirubin: Grade 2 | 3.7 | 0 |
| Post Challenge: Hyperglycemia: Grade 1 | 0 | 3.8 |
| Post Challenge: Hyperkalemia: Grade 1 | 3.7 | 3.8 |
| Post Challenge: Hypernatremia: Grade 2 | 3.7 | 0 |
| Post Challenge: Hypophosphatemia:Grade 1 | 3.7 | 0 |
| Post Challenge: Hypoproteinemia:Grade 1 | 11.1 | 0 |
| Post Challenge: Eosinophils: Grade 1 | 0 | 7.7 |
| Post Challenge: Hemoglobin: Grade 1 | 7.4 | 0 |
| Post Challenge: Neutrophils: Grade 1 | 7.4 | 0 |
| Post Challenge: Platelets: Grade 1 | 3.7 | 3.8 |
| Post Challenge: Platelets: Grade 20 | 0 | 3.8 |
| Post Challenge: WBC increase: Grade 1 | 3.7 | 0 |
Collected over Up to 6 months post-vaccination and up to 6 months post-challenge. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Post-dose: Ad26.RSV.preF (1x10^11 vp) | 0/31 (0%) | 0/31 (0%) | 4/31 (12.9%) |
| Post-dose: Placebo | 0/32 (0%) | 0/32 (0%) | 9/32 (28.1%) |
| Post-challenge: Challenge After Ad26.RSV.preF | 0/27 (0%) | 1/27 (3.7%) | 16/27 (59.3%) |
| Post-challenge: Challenge After Placebo | 0/26 (0%) | 0/26 (0%) | 16/26 (61.5%) |
| Event | Post-dose: Ad26.RSV.preF (1x10^11 vp) | Post-dose: Placebo | Post-challenge: Challenge After Ad26.RSV.preF | Post-challenge: Challenge After Placebo |
|---|---|---|---|---|
| Ovarian CystReproductive system and breast disorders | 0/31 | 0/32 | 1/27 | 0/26 |
| Event | Post-dose: Ad26.RSV.preF (1x10^11 vp) | Post-dose: Placebo | Post-challenge: Challenge After Ad26.RSV.preF | Post-challenge: Challenge After Placebo |
|---|---|---|---|---|
| Alanine Aminotransferase IncreasedInvestigations | 2/31 | 0/32 | 7/27 | 3/26 |
| LymphadenopathyBlood and lymphatic system disorders | 0/31 | 0/32 | 6/27 | 1/26 |
| PharyngitisInfections and infestations | 0/31 | 0/32 | 3/27 | 4/26 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/31 | 0/32 | 1/27 | 4/26 |
| HeadacheNervous system disorders | 1/31 | 4/32 | 2/27 | 2/26 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/31 | 0/32 | 0/27 | 3/26 |
| Dry SkinSkin and subcutaneous tissue disorders | 1/31 | 1/32 | 3/27 | 2/26 |
| NauseaGastrointestinal disorders | 0/31 | 0/32 | 0/27 | 2/26 |
| Aspartate Aminotransferase IncreasedInvestigations | 2/31 | 1/32 | 2/27 | 2/26 |
| Troponin T IncreasedInvestigations | 0/31 | 0/32 | 0/27 | 2/26 |
| Age, Continuous(years) | Ad26.RSV.preF (1*10^11 vp) | Placebo | Total |
|---|---|---|---|
| Mean | 25.9 ± 6.19 | 25.9 ± 6.56 | 25.9 ± 6.33 |
| Sex: Female, Male(Participants) | Ad26.RSV.preF (1*10^11 vp) | Placebo | Total |
|---|---|---|---|
| Female | 12 | 6 | 18 |
| Male | 19 | 26 | 45 |
| Ethnicity (NIH/OMB)(Participants) | Ad26.RSV.preF (1*10^11 vp) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 30 | 32 | 62 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Ad26.RSV.preF (1*10^11 vp) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 24 | 28 | 52 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Region of Enrollment(Participants) | Ad26.RSV.preF (1*10^11 vp) | Placebo | Total |
|---|---|---|---|
| UNITED KINGDOM | 31 | 32 | 63 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: AD26.RSV.PREF
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