A Phase 2 interventional study of RSVPreF and Placebo in Respiratory Syncytial Virus Infections, sponsored by Hvivo. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Hvivo · Phase 2, Interventional, and Prevention
In this randomised, placebo-controlled, double-blind Phase 2a study, healthy male and female participants 18-50 years of age will be given an investigational RSV vaccine (RSVpreF) and challenged with RSV one month later. The purpose of this research study is to assess the safety, immunogenicity and efficacy of RSVpreF using a human viral challenge model.
Respiratory Syncytial Virus (RSV) is a common virus that affects all human age groups and can cause a range of respiratory disease such as bronchitis and lower respiratory infections. These serious illnesses affect infants and adults who are older especially if they are over 65, have chronic heart or lung disease or have a weakened immune system. Vaccination against RSV has the potential to be a highly beneficial and effective approach to reduce RSV disease in older adults and pediatric populations, however there is no current vaccine approved for the prevention of RSV infections.
RSVpreF is being developed to prevent RSV-associated moderate to severe lower respiratory tract disease in adults 60 years of age and in infants by active immunization of pregnant women.
This study is an exploratory proof-of-concept to assess the safety, immunogenicity and efficacy of RSVpreF using a human challenge model. The RSV challenge model is developed to help understanding the RSV disease and assess new vaccines by testing them in participants deliberately infected with the virus.
In this study, approximately 62 (up to 72) participants will be vaccinated with the investigational RSVpreF to account for withdrawals between vaccination and challenge. Participants will be randomised 1:1 to receive RSVpreF or placebo.
The study will consist of a vaccination phase, quarantine phase and a follow-up phase.
306 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 50 are open to participants now.
This study's enrollment of 70 is below the median of 89 across 223 interventional studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →Hvivo is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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.
The following criteria are applicable to female participants participating in the study.
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The following criteria apply to female and male participants:
Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 28 days after the date of Viral challenge / last dosing with IMP (whichever occurs last): a. Use a condom with a spermicide to prevent pregnancy in a female partner or to prevent exposure of any partner (male and female) to the IMP. b. Male sterilisation with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate (please note that the use of condom with spermicide will still be required to prevent partner exposure). This applies only to males participating in the study. c. In addition, for female partners of child bearing potential, that partner must use another form of contraception such as one of the highly effective methods mentioned above for female participants.
In addition to the contraceptive requirements above, male participants must agree not to donate sperm following discharge from quarantine until 28 days after the date of Viral Challenge/last dosing with IMP (whichever occurs last).
Exclusion Criteria:
a) Any history or evidence of any other or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
b) And/or other major disease that, in the opinion of the Investigator, may put the participant at undue risk, or interfere with a participant completing the study and necessary investigations (e.g disease or immunodeficiency).
Females who:
a) Evidence of vaccinations with licensed within the 4 weeks prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first). Evidence of vaccinations with licensed vaccines which are not live attenuated within the 2 weeks prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).
b) Intention to receive any vaccination(s) before at least 28 days after the viral challenge (NB. No travel restrictions will apply after the Day 28 Follow-up visit).
a) Receipt of any drug within 3 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).
b) Previous vaccination with any licensed or investigational RSV vaccine before enrolment into the study. c) Receipt of three or more investigational drugs within the previous 12 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first).
d) Prior inoculation with a virus from the same virus-family as the challenge virus.
e) Prior participation in another human viral challenge study with a respiratory virus in the preceding 3 months, taken from the date of viral challenge in the previous study to the date of expected viral challenge in this study.
f) Receipt of treatment with therapy.
a) Confirmed positive test for drugs of abuse and cotinine on first study visit. One repeat test allowed at PI discretion.
b) History or presence of alcohol addiction, or excessive use of alcohol
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
A single intramuscular injection at a dose of 120 mcg reconstituted with sterile water for an 0.5 mL injection volume
Biological: RSVPreF
A single intramuscular injection of Placebo to match active vaccine
Other: Placebo
A single dose of 120 mcg RSVpreF for intramuscular injection
A single Placebo dose for intramuscular injection to match experimental vaccine
Area Under the Viral Load-time Curve (VL-AUC) of RSV
The VL-AUC of RSV determined by qRT-PCR from nasal wash samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
Time frame: Day 2 to Day 12
Number of Participants With RT-PCR Confirmed (Detected) Incidence of Symptomatic Infection
RT-PCR-confirmed symptomatic RSV infection defined as: - Two detectable qRT-PCR reported on 2 or more consecutive days (any two detectable (≥LLOD) qRT-PCR measurements reported over 4 consecutive scheduled timepoints). and - Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category
Time frame: Day 2 to Day 12
Sum Total Symptoms Diary Card Score (TSS)
The sum total symptoms score is the sum of all scores from the first assessment on Day 1 to the first assessment on Day 12 (34 assessments). Symptom scores were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).
Time frame: Day 1 to Day 12
Number of Participants With RT-PCR Confirmed (Quantifiable) Incidence of Symptomatic Infection
RT-PCR confirmed RSV infection defined as * Two quantifiable PCR measures reported on 2 or more consecutive days (any two quantifiable (≥LLOQ) qRT-PCR measurements reported over 4 consecutive scheduled timepoints), and * Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category
Time frame: Day 2 to Day 12
Number of Participants With Culture Lab-confirmed Reduction of Symptomatic RSV Infection
Culture lab-confirmed symptomatic RSV infection defined as: * One quantifiable viral culture and * Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category
Time frame: Day 2 to Day 12
Peak Viral Load of RSV by qRT-PCR
Reduction in Peak viral load of RSV determined by quantifiable qRT-PCR from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
Time frame: Day 2 to Day 12
Peak Viral Load of RSV by Viral Culture
Peak viral load of RSV determined by quantifiable viral culture from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
Time frame: Day 2 to Day 12
Duration of Quantifiable qRT-PCR Measurements
Duration (time in hours) of quantifiable qRT-PCR measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
Time frame: Day 2 to Day 12
Duration of Quantitative Viral Culture Measurements
Duration (time in hours) of quantitative viral culture measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
Time frame: Day 2 to Day 12
VL-AUC Determined by Quantitative Viral Culture
VL-AUC of RSV as determined by quantitative viral culture on nasal samples starting two days post-viral challenge (Day +2) up to discharge from quarantine
Time frame: Day 2 to Day 12
Area Under the Curve Over Time of Total Clinical Symptoms (TSS-AUC)
Data presented is hours \* score. TSS-AUC (trapezium rule) as measured by graded symptom scoring system collected 3 times daily starting Day +1 up to Day 12am using a participant self-reportable 13-symptoms card, the max number of diary cards included in the AUC calculation is 34, the maximum time period is 264hrs. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) - 3(severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). The range of TSS AUC scores are between 0 and 10,824 hours\*score (maximum of 264x41).
Time frame: Day 1 to Day 12
Peak Symptoms Diary Card Score
Peak TSS for each participant is defined as the diary card total with the worst score (highest). The symptom scoring system was collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).
Time frame: Day 1 to Day 12
Peak Daily Symptom Score
Peak daily symptom score was derived, for each day from Day 1 to Day 12, as the maximum of the 3 total symptoms scores on that day, providing 11 scores each. The symptoms were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).
Time frame: Day 1 to Day 12
Percentage Number of Participants With Grade 2 or Higher Symptoms
Number (%) of participants with Grade 2 or higher symptoms (on any occasion from Day 1 to Day 12)
Time frame: Day 1 to Day 12
Number of Participants With an Occurrence of at Least Two Positive Quantifiable qRT-PCR Measurements on 2 or More Consecutive Days
The number of participants with at least two quantifiable positive (≥LLOQ) qRT-PCR nasal sample measurements across 4 consecutive visits
Time frame: Day 2 to Day 12
Number of Participants With an Occurrence of at Least Two Positive Detectable qRT-PCR Measurements on 2 or More Consecutive Days
The proportion of participants with at least two positive detectable qRT-PCR nasal sample measurements across 4 consecutive visits
Time frame: Day 2 to Day 12
Number of Participants With an Occurrence of at Least One Positive Quantitative Cell Culture Measurements
The proportion of participants with at least one quantifiable positive (≥LLOQ) nasal sample viral culture starting two days post-viral challenge (Day+2) up to discharge from quarantine. Viral culture is only done for samples where qRT-PCR is positive (detectable), when the qRT-PCR is negative the viral culture is assumed to be 0 for any endpoint derivations.
Time frame: Day 2 to Day 12
Total Mucus Weight
Total weight of mucus produced starting one day post-viral challenge (Day +1) up to discharge from quarantine. The mean sum of all mucus produced from Day 1 to Day 12 is reported in data table.
Time frame: Day 1 to Day 12
Total Tissue Number
Total number of tissues used by participants starting one day post-viral challenge (Day +1) up to discharge from quarantine.
Time frame: Day 1 to Day 12
Number of Solicited Local Reactions Within 7 Days After Vaccination
Local reactions include pain at injection site, redness and swelling
Time frame: 7 days post vaccination
Number of Systemic Events Within 7 Days After Vaccination
Systemic reactions included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain. Each of these items was collected on a four-point scale including, none, mild, moderate, and severe.
Time frame: 7 days post vaccination
Number of Participants With an Occurrence of Unsolicited Adverse Events (AEs) Post Vaccination
Number of participants with at least one unsolicited adverse events (AEs) within 30 days after vaccination. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.
Time frame: 30 days
Occurrence of Medically Attended AEs
Number of medically attended AEs from vaccination to study end
Time frame: Through study completion, an average of 6 months
Occurrence of SAEs
Number of SAEs from vaccination to study end
Time frame: Through study completion, an average of 6 months
Number of Participants With an Occurrence of Unsolicited AEs Related to Viral Challenge
Number of participants with at least one unsolicited AE within 30 days post-viral challenge (Day 0) up to Day +28 follow up. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.
Time frame: Day 0 to Day 28
Occurrence of Haematological and Biochemical Laboratory Abnormalities During the Quarantine Period.
Number of hematological and biochemical laboratory assessment Abnormalities reported as AEs during the quarantine period.
Time frame: Day -2 to Day12
Use of Concomitant Medication
Concomitant medications (prescription and over the counter drugs and supplements that a study participant had taken alongside the study vaccination) were recorded for the period following vaccination (up to viral challenge) and from viral challenge until Day 28..
Time frame: From Vaccination (Day -28) until Viral Challenge (Day 0), and From Viral Challenge (Day 0) until Day 28
70 participants were to be enrolled and vaccinated with the study vaccine, with 62 participants challenged with the study virus.
| Milestone | RSVPreF | Placebo |
|---|---|---|
| Started | 35 | 35 |
| Completed | 31 | 31 |
| Not completed | 4 | 4 |
The VL-AUC of RSV determined by qRT-PCR from nasal wash samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
| h*log10 PFU/mL | RSVPreF | Placebo |
|---|---|---|
| Area Under the Viral Load-time Curve (VL-AUC) of RSV | 0.00 (0.0 to 19.02) | 96.65 (0.0 to 675.32) |
RT-PCR-confirmed symptomatic RSV infection defined as: - Two detectable qRT-PCR reported on 2 or more consecutive days (any two detectable (≥LLOD) qRT-PCR measurements reported over 4 consecutive scheduled timepoints). and - Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Participants With RT-PCR Confirmed (Detected) Incidence of Symptomatic Infection | 2 | 15 |
The sum total symptoms score is the sum of all scores from the first assessment on Day 1 to the first assessment on Day 12 (34 assessments). Symptom scores were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).
| score on a scale | RSVPreF | Placebo |
|---|---|---|
| Sum Total Symptoms Diary Card Score (TSS) | 2.1 ± 199.8 | 28.9 ± 120.2 |
RT-PCR confirmed RSV infection defined as * Two quantifiable PCR measures reported on 2 or more consecutive days (any two quantifiable (≥LLOQ) qRT-PCR measurements reported over 4 consecutive scheduled timepoints), and * Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Participants With RT-PCR Confirmed (Quantifiable) Incidence of Symptomatic Infection | 0 | 13 |
Culture lab-confirmed symptomatic RSV infection defined as: * One quantifiable viral culture and * Either one or more positive clinical symptoms from different categories in the symptom scoring system or one Grade 2 symptom from any category
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Participants With Culture Lab-confirmed Reduction of Symptomatic RSV Infection | 0 | 11 |
Reduction in Peak viral load of RSV determined by quantifiable qRT-PCR from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
| log 10 copies/mL | RSVPreF | Placebo |
|---|---|---|
| Peak Viral Load of RSV by qRT-PCR | 0.00 (0.0 to 3.1080) | 4.2 (0.0 to 6.9990) |
Peak viral load of RSV determined by quantifiable viral culture from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
| log 10 PFU/mL | RSVPreF | Placebo |
|---|---|---|
| Peak Viral Load of RSV by Viral Culture | 0.00 ± 0.00 | 1.921 ± 2.3837 |
Duration (time in hours) of quantifiable qRT-PCR measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
| hours | RSVPreF | Placebo |
|---|---|---|
| Duration of Quantifiable qRT-PCR Measurements | 18.0 (11.8 to 54.4) | 131.6 (72.1 to NA) |
Duration (time in hours) of quantitative viral culture measurements from nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to discharge from quarantine.
| hours | RSVPreF | Placebo |
|---|---|---|
| Duration of Quantitative Viral Culture Measurements | — | 83.1 (60.2 to 95.8) |
VL-AUC of RSV as determined by quantitative viral culture on nasal samples starting two days post-viral challenge (Day +2) up to discharge from quarantine
| h*log10 PFU/mL | RSVPreF | Placebo |
|---|---|---|
| VL-AUC Determined by Quantitative Viral Culture | 0.00 ± 0.00 | 91.91 ± 127.883 |
Data presented is hours \* score. TSS-AUC (trapezium rule) as measured by graded symptom scoring system collected 3 times daily starting Day +1 up to Day 12am using a participant self-reportable 13-symptoms card, the max number of diary cards included in the AUC calculation is 34, the maximum time period is 264hrs. Clinical symptoms included runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptom from 0 (no symptoms) - 3(severe). Shortness of breath and wheeze had an additional scoring option of grade 4. Dairy card total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4). The range of TSS AUC scores are between 0 and 10,824 hours\*score (maximum of 264x41).
| hours * score on a scale | RSVPreF | Placebo |
|---|---|---|
| Area Under the Curve Over Time of Total Clinical Symptoms (TSS-AUC) | 52.85 ± 105.250 | 230.76 ± 277.988 |
Peak TSS for each participant is defined as the diary card total with the worst score (highest). The symptom scoring system was collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).
| score on a scale | RSVPreF | Placebo |
|---|---|---|
| Peak Symptoms Diary Card Score | 1.3 ± 1.79 | 4.1 ± 3.92 |
Peak daily symptom score was derived, for each day from Day 1 to Day 12, as the maximum of the 3 total symptoms scores on that day, providing 11 scores each. The symptoms were collected three times daily starting one day post-viral challenge (Day +1) up to discharge from quarantine using a participant self-reportable 13-symptoms card. Clinical symptoms include runny nose, stuffy nose, sneezing, sore throat, earache, malaise/tiredness, headache, muscle or joint ache, chilliness/feverishness, cough, chest tightness, shortness of breath, and wheeze. Participants scored symptoms from 0 (no symptoms) - 3 (severe). Shortness of breath and wheeze had an additional scoring option of grade 4. For each assessment, an individual total symptom score was derived as the total of the scores given to the 13 symptoms on that symptom score card. Individual total symptom scores ranged from 0 (if all symptoms graded 0) to 41 (if all symptoms graded 3 and shortness of breath and wheeze graded 4).
| score on a scale | RSVPreF | Placebo |
|---|---|---|
| Day 1 | 0.6 ± 1.38 | 0.2 ± 0.56 |
| Day 2 | 0.4 ± 0.76 | 0.3 ± 0.70 |
| Day 3 | 0.3 ± 0.69 | 0.2 ± 0.50 |
| Day 4 | 0.3 ± 0.73 | 1.1 ± 2.16 |
| Day 5 | 0.5 ± 1.48 | 1.6 ± 2.78 |
| Day 6 | 0.6 ± 1.12 | 2.2 ± 2.77 |
| Day 7 | 0.4 ± 0.71 | 2.5 ± 3.04 |
| Day 8 | 0.3 ± 0.58 | 2.5 ± 3.30 |
| Day 9 | 0.3 ± 0.51 | 1.3 ± 1.59 |
| Day 10 | 0.2 ± 0.55 | 0.7 ± 1.03 |
| Day 11 | 0.2 ± 0.75 | 0.8 ± 1.51 |
| Day 12 | 0.0 ± 0.18 | 0.5 ± 1.89 |
Number (%) of participants with Grade 2 or higher symptoms (on any occasion from Day 1 to Day 12)
| Participants | RSVPreF | Placebo |
|---|---|---|
| Percentage Number of Participants With Grade 2 or Higher Symptoms | 5 | 16 |
The number of participants with at least two quantifiable positive (≥LLOQ) qRT-PCR nasal sample measurements across 4 consecutive visits
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Participants With an Occurrence of at Least Two Positive Quantifiable qRT-PCR Measurements on 2 or More Consecutive Days | 4 | 16 |
The proportion of participants with at least two positive detectable qRT-PCR nasal sample measurements across 4 consecutive visits
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Participants With an Occurrence of at Least Two Positive Detectable qRT-PCR Measurements on 2 or More Consecutive Days | 10 | 23 |
The proportion of participants with at least one quantifiable positive (≥LLOQ) nasal sample viral culture starting two days post-viral challenge (Day+2) up to discharge from quarantine. Viral culture is only done for samples where qRT-PCR is positive (detectable), when the qRT-PCR is negative the viral culture is assumed to be 0 for any endpoint derivations.
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Participants With an Occurrence of at Least One Positive Quantitative Cell Culture Measurements | 0 | 13 |
Total weight of mucus produced starting one day post-viral challenge (Day +1) up to discharge from quarantine. The mean sum of all mucus produced from Day 1 to Day 12 is reported in data table.
| g | RSVPreF | Placebo |
|---|---|---|
| Total Mucus Weight | 6.367 ± 9.8246 | 29.135 ± 36.2811 |
Total number of tissues used by participants starting one day post-viral challenge (Day +1) up to discharge from quarantine.
| Tissues | RSVPreF | Placebo |
|---|---|---|
| Total Tissue Number | 16.9 ± 22.35 | 41.7 ± 44.80 |
Local reactions include pain at injection site, redness and swelling
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Solicited Local Reactions Within 7 Days After Vaccination | 5 | 2 |
Systemic reactions included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain. Each of these items was collected on a four-point scale including, none, mild, moderate, and severe.
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Systemic Events Within 7 Days After Vaccination | 18 | 11 |
Number of participants with at least one unsolicited adverse events (AEs) within 30 days after vaccination. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Participants With an Occurrence of Unsolicited Adverse Events (AEs) Post Vaccination | 12 | 10 |
Number of medically attended AEs from vaccination to study end
| Participants | RSVPreF (From Vaccination Until Viral Challenge) | Placebo (From Vaccination Until Viral Challenge) | RSVPreF (From Viral Challenge Until Day 28) | Placebo (From Viral Challenge Until Day 28) | RSVPreF (From Day 28 Until Day155) | Placebo (From Day 28 Until Day155) |
|---|---|---|---|---|---|---|
| Occurrence of Medically Attended AEs | 1 | 2 | 2 | 1 | 2 | 0 |
Number of SAEs from vaccination to study end
| Participants | RSVPreF | Placebo |
|---|---|---|
| Occurrence of SAEs | 1 | 1 |
Number of participants with at least one unsolicited AE within 30 days post-viral challenge (Day 0) up to Day +28 follow up. Unsolicited AEs were all AEs for which participants were not specifically questioned in the participant diary.
| Participants | RSVPreF | Placebo |
|---|---|---|
| Number of Participants With an Occurrence of Unsolicited AEs Related to Viral Challenge | 14 | 17 |
Number of hematological and biochemical laboratory assessment Abnormalities reported as AEs during the quarantine period.
| Participants | RSVPreF | Placebo |
|---|---|---|
| Mild raised ALT | 8 | 5 |
| Moderate raised ALT | 1 | 1 |
| Mild raised AST | 2 | 5 |
| Moderate raised AST | 1 | 0 |
| Moderate raised CK | 0 | 1 |
| Mild low platelets | 0 | 1 |
| Mild low lymphocytes | 0 | 1 |
| Moderate low neutrophils | 0 | 1 |
Concomitant medications (prescription and over the counter drugs and supplements that a study participant had taken alongside the study vaccination) were recorded for the period following vaccination (up to viral challenge) and from viral challenge until Day 28..
| Participants | RSVPreF | Placebo |
|---|---|---|
| Concomitant Medications from Vaccination (Day -28) until Viral Challenge (Day 0) | 9 | 11 |
| Concomitant Medications from Viral Challenge (Day 0) until Day 28 | 14 | 14 |
Collected over Adverse events (AEs) were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155. Medically attended AEs and SAEs were recorded from vaccination (Day -28) up until viral challenge (Day 0 pre-challenge), following viral challenge (Day 0 post-challenge) until Day 28, and from Day 28 until Day 155.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RSVPreF (From Vaccination Until Viral Challenge) | 0/35 (0%) | 0/35 (0%) | 12/35 (34.3%) |
| Placebo (From Vaccination Until Viral Challenge) | 0/35 (0%) | 0/35 (0%) | 9/35 (25.7%) |
| RSVPreF (From Viral Challenge Until Day 28) | 0/35 (0%) | 0/35 (0%) | 2/35 (5.7%) |
| Placebo (From Viral Challenge Until Day 28) | 0/35 (0%) | 1/35 (2.9%) | 1/35 (2.9%) |
| RSVPreF (From Day 28 Until Day155) | 0/35 (0%) | 1/35 (2.9%) | 2/35 (5.7%) |
| Placebo (From Day 28 Until Day155) | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Event | RSVPreF (From Vaccination Until Viral Challenge) | Placebo (From Vaccination Until Viral Challenge) | RSVPreF (From Viral Challenge Until Day 28) | Placebo (From Viral Challenge Until Day 28) | RSVPreF (From Day 28 Until Day155) | Placebo (From Day 28 Until Day155) |
|---|---|---|---|---|---|---|
| MyocarditisCardiac disorders | — | — | — | 1/35 | 0/35 | — |
| Meningitis viralInfections and infestations | — | — | — | 0/35 | 1/35 | — |
| Event | RSVPreF (From Vaccination Until Viral Challenge) | Placebo (From Vaccination Until Viral Challenge) | RSVPreF (From Viral Challenge Until Day 28) | Placebo (From Viral Challenge Until Day 28) | RSVPreF (From Day 28 Until Day155) | Placebo (From Day 28 Until Day155) |
|---|---|---|---|---|---|---|
| Dry skinSkin and subcutaneous tissue disorders | 2/35 | 2/35 | 1/35 | 0/35 | 0/35 | 0/35 |
| LymphadenopathyBlood and lymphatic system disorders | 1/35 | 0/35 | 0/35 | 0/35 | 0/35 | 0/35 |
| PalpitationsCardiac disorders | 0/35 | 1/35 | 0/35 | 0/35 | 0/35 | 0/35 |
| Abdominal painGastrointestinal disorders | 0/35 | 1/35 | 0/35 | 0/35 | 0/35 | 0/35 |
| NauseaGastrointestinal disorders | 1/35 | 0/35 | 0/35 | 0/35 | 0/35 | 0/35 |
| Vessel puncture site bruiseGeneral disorders | 0/35 | 1/35 | 0/35 | 0/35 | 0/35 | 0/35 |
| ConjunctivitisInfections and infestations | 0/35 | 1/35 | 0/35 | 0/35 | 0/35 | 0/35 |
| PharyngitisInfections and infestations | 1/35 | 0/35 | 0/35 | 0/35 | 0/35 | 0/35 |
| Alanine aminotransferase increasedInvestigations | 0/35 | 1/35 | 1/35 | 0/35 | 0/35 | 0/35 |
| Blood creatine phosphokinase increasedInvestigations | 0/35 | 1/35 | 0/35 | 0/35 | 0/35 | 0/35 |
| Age, Continuous(years) | RSVPreF | Placebo | Total |
|---|---|---|---|
| Mean | 26.0 ± 6.46 | 27.1 ± 6.78 | 26.5 ± 6.60 |
| Sex: Female, Male(Participants) | RSVPreF | Placebo | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 25 | 25 | 50 |
| Race (NIH/OMB)(Participants) | RSVPreF | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 31 | 34 | 65 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 0 | 3 |
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Studies of the drug tested here: Abrysvo
Respiratory Syncytial Virus Infections →
Hvivo