RSV InfectionPhase 2NCT04752644
Phase 2a Study of MVA-BN-RSV Vaccination and RSV Challenge in Healthy Adults
A Phase 2 study testing MVA-mBN294B in people with RSV Infection, run by Bavarian Nordic at 1 site in United Kingdom.
Trial summary
A Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the Recombinant MVA-BN®-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection
- What is being tested?
- MVA-mBN294B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Feb 2021to 2 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. An informed consent document signed and dated by the participant and the Investigator 2. Aged between 18 and 50 years old on the day of signing the consent form 3. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the Investigator 4. A documented medical history prior to enrolment 5. The following criteria are applicable to female participants participating in the study.
- Females of childbearing potential must have a negative pregnancy test prior to enrolment.
- Females of non-childbearing potential:
- Post-menopausal* females; defined as having a history of amenorrhea for >12 months with no alternative medical cause, and /or by FSH level >40mLU/mL, confirmed by laboratory.
- Documented status as being surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomyhysterectomy, bilateral salpingectomy and bilateral oophorectomy) 6. The following criteria apply to female and male participants:
- Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to the first study visit. The contraception use must continue until 28 days after the date of viral challenge. Highly effective contraception is as described below: i. Established use of hormonal methods of contraception described below (for a minimum of 2 weeks prior to the first study visit). When hormonal methods of contraception are used, male are required to use a condom with a spermicide: ii. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
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- 1. oral 2. intravaginal 3. transdermal iii. progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable iv. Intrauterine device (IUD) v. Intrauterine hormone-releasing system (IUS) vi. Bilateral tubal ligation vii. Male sterilisation (with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate) where the vasectomised male is the sole partner for that woman.
- True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant.
- Male participants must agree to the contraceptive requirements below from the vaccination visit and continue until 28 days after the date of Viral challenge: i. 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.
- 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.
- In addition, for female partners of childbearing potential, that partner must use another form of contraception such as one of the highly effective methods mentioned above for female participants.
- True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant.
- 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).
- 7. Sero-suitable to the challenge virus, as defined in the study Analytical Plan.
Who cannot join
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit
- Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
- 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 autoimmune disease or immunodeficiency).
- Participants who have smoked ≥10 pack years at any time [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years].
- A total body weight ≤50 kg or Body Mass Index (BMI) ≤18 kg/m2 or ≥35kg/m2.
- Females who:
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- Are breastfeeding, or
- Have been pregnant within 6 months prior to the study.
- History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug or vaccine, as assessed by the PI.
- Venous access deemed inadequate for the phlebotomy and cannulation demands of the study
- Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge, (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
- Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalized due to epistaxis on any previous occasion.
- Any nasal or sinus surgery within 3 months of the first study visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the Recombinant MVA-BN®-RSV Vaccine Against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants
A Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the Recombinant MVA-BN®-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants
- Conditions
- RSV Infection
- Being tested
- MVA-mBN294B, Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-mBN294BBiological
MVA-BN-RSV (nominal titre 5 x10*8 Inf.U per 0.5 mL) as intramuscular injections. Liquid frozen suspension, single dose of 0.5ml.
PlaceboDrug
TBS (Placebo) as intramuscular injections (0.5ml)
| Study group | Role | What they receive |
|---|---|---|
| Group1: MVA-BN-RSV | Experimental | Participants will receive one intramuscular injection of MVA-BN-RSV (nominal titre 5 x 10*8 Inf.U per 0.5 mL) given on day -28 before RSV challenge on day 0.
On day 0, intranasal challenge with RSV-A (Memphis 37b strain) virus will occur for all participants Receives: Biological: MVA-mBN294B |
| Group 2: Placebo | Placebo comparator | Participants will receive one intramuscular injection of Tris-Buffered-Saline (0.5 mL) given on day -28 before RSV challenge on day 0.
On day 0, intranasal challenge with RSV-A (Memphis 37b strain) virus will occur for all participants Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b
Median VL-AUC of RSV-A Memphis 37b as determined by qRT-PCR from nasal washes collected twice daily
Measured: From Day 2 post-viral challenge up to discharge from Quarantine (Day12).
Secondary outcomes (10)
Peak viral load of RSV-A Memphis 37b
Peak viral load of RSV-A Memphis 37b is defined by the maximum viral load in nasal washes
Measured: From Day 2 post-viral challenge up to discharge from Quarantine (Day12).
Total clinical symptom score (TSS)
Total clinical symptom score (TSS) determined as the sum of the scores as collected on the participants' symptom diary cards, collected three times daily.
Measured: From Day 1 post-viral challenge up to discharge from Quarantine (Day12).
Percentage of participants with RT-PCR-confirmed RSV infection
RT-PCR-confirmed RSV infection [at least two detectable (≥LLOD) qRT-PCR measurements (reported on 2 or more consecutive days), starting two days post-viral challenge (Day 2) up to discharge from Quarantine], AND 1 or more positive clinical symptoms of Grade 2 or more from any category in the symptom scoring system (Upper Respiratory, Lower Respiratory, Systemic)
Measured: From Day 2 up to discharge from Quarantine (Day12)
Weight of mucus produced
Median AUC of mucus weight produced
Measured: From Day 1 post-viral challenge up to discharge from Quarantine (Day12).
Occurrence of solicited local reactions and systemic events
Local reactions (pain, swelling, redness, induration, itching) and systemic events (including body temperature)
Measured: From day of vaccination (Day-28) and 7 subsequent days) after vaccination
Occurrence of unsolicited adverse events (AEs)
Unsolicited AEs are defined as AEs observed by the participant or investigator which are not pre-listed on the memory aid card/symptom score card
Measured: Between vaccination (Day-28) and inoculation with RSV Memphis 37b (Day0)
Occurrence of medically attended AEs (MAEs)
A medically attended adverse event (MAE) is an adverse event, whether considered related to the investigational vaccine or not, that led to the participant seeking evaluation by a healthcare provider
Measured: From vaccination (Day -28) up to study end (Day 155 (±14 days)).
Serious adverse events (SAEs)
SAEs are defined as any untoward medical occurrence that at any dose:
results in death, is life threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, is an important medical event
Measured: From vaccination (Day -28) up to study end (Day 155 (±14 days)).
Occurrence of unsolicited AEs
Unsolicited AEs are defined as AEs observed by the participant or investigator which are not pre-listed on the memory aid card/symptom score card
Measured: From Day 0 up to Day 28 follow up
Occurrence of SAEs
Occurrence of SAEs related to the viral challenge
Measured: From Day 0 up to Day 28 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start22 Feb 2021
- Primary completion17 Jun 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752644
- Sponsor's protocol ID
- RSV-MVA-015
- Status last verified
- Jul 2023
- First submitted
- 9 Feb 2021
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jordan E, Kabir G, Schultz S, Silbernagl G, Schmidt D, Jenkins VA, Weidenthaler H, Stroukova D, Martin BK, De Moerlooze L. Reduced Respiratory Syncytial Virus Load, Symptoms, and Infections: A Human Challenge Trial of MVA-BN-RSV Vaccine. J Infect Dis. 2023 Oct 18;228(8):999-1011. doi: 10.1093/infdis/jiad108.
PubMed 37079393
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the Recombinant MVA-BN®-RSV Vaccine Against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04752644
- Acronym / sponsor ID
- RSV-MVA-015
- Conditions
- RSV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the Recombinant MVA-BN®-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: MVA-BN-RSV | Experimental | Biological: MVA-mBN294BParticipants will receive one intramuscular injection of MVA-BN-RSV (nominal titre 5 x 10*8 Inf.U per 0.5 mL) given on day -28 before RSV challenge on day 0. On day 0, intranasal challenge with RSV-A (Memphis 37b strain) virus will occur for all participants |
| Group 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive one intramuscular injection of Tris-Buffered-Saline (0.5 mL) given on day -28 before RSV challenge on day 0. On day 0, intranasal challenge with RSV-A (Memphis 37b strain) virus will occur for all participants |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 1. An informed consent document signed and dated by the participant and the Investigator 2. Aged between 18 and 50 years old on the day of signing the consent form 3. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the Investigator 4. A documented medical history prior to enrolment 5. The following criteria are applicable to female participants participating in the study.
- Females of childbearing potential must have a negative pregnancy test prior to enrolment.
- Females of non-childbearing potential:
- Post-menopausal* females; defined as having a history of amenorrhea for >12 months with no alternative medical cause, and /or by FSH level >40mLU/mL, confirmed by laboratory.
- Documented status as being surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomyhysterectomy, bilateral salpingectomy and bilateral oophorectomy) 6. The following criteria apply to female and male participants:
Key exclusion criteria (13 listed)
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit
- Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
- 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 autoimmune disease or immunodeficiency).
- Participants who have smoked ≥10 pack years at any time [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years].
- A total body weight ≤50 kg or Body Mass Index (BMI) ≤18 kg/m2 or ≥35kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA-mBN294BMVA-BN-RSV (nominal titre 5 x10*8 Inf.U per 0.5 mL) as intramuscular injections. Liquid frozen suspension, single dose of 0.5ml. | Biological | Group1: MVA-BN-RSV |
| PlaceboTBS (Placebo) as intramuscular injections (0.5ml) | Drug | Group 2: Placebo |
Primary outcome
Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b
Time frame: From Day 2 post-viral challenge up to discharge from Quarantine (Day12).
Median VL-AUC of RSV-A Memphis 37b as determined by qRT-PCR from nasal washes collected twice daily
10 secondary outcomes
Peak viral load of RSV-A Memphis 37b
Time frame: From Day 2 post-viral challenge up to discharge from Quarantine (Day12).
Total clinical symptom score (TSS)
Time frame: From Day 1 post-viral challenge up to discharge from Quarantine (Day12).
Percentage of participants with RT-PCR-confirmed RSV infection
Time frame: From Day 2 up to discharge from Quarantine (Day12)
Weight of mucus produced
Time frame: From Day 1 post-viral challenge up to discharge from Quarantine (Day12).
Occurrence of solicited local reactions and systemic events
Time frame: From day of vaccination (Day-28) and 7 subsequent days) after vaccination
Occurrence of unsolicited adverse events (AEs)
Time frame: Between vaccination (Day-28) and inoculation with RSV Memphis 37b (Day0)
Occurrence of medically attended AEs (MAEs)
Time frame: From vaccination (Day -28) up to study end (Day 155 (±14 days)).
Serious adverse events (SAEs)
Time frame: From vaccination (Day -28) up to study end (Day 155 (±14 days)).
Occurrence of unsolicited AEs
Time frame: From Day 0 up to Day 28 follow up
Occurrence of SAEs
Time frame: From Day 0 up to Day 28 follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 37079393Jordan E, Kabir G, Schultz S, Silbernagl G, Schmidt D, Jenkins VA, Weidenthaler H, Stroukova D, Martin BK, De Moerlooze L. Reduced Respiratory Syncytial Virus Load, Symptoms, and Infections: A Human Challenge Trial of MVA-BN-RSV Vaccine. J Infect Dis. 2023 Oct 18;228(8):999-1011. doi: 10.1093/infdis/jiad108.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA-mBN294B in people with RSV Infection, run by Bavarian Nordic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b (time frame: From Day 2 post-viral challenge up to discharge from Quarantine (Day12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.