RSV InfectionPhase 2NCT04690335
Human Challenge Study to Evaluate the Efficacy of MV-012-968 Vaccine
A Phase 2 study testing MV-012-968 in people with RSV Infection, run by Meissa Vaccines, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic RSV infection when administered to adults 18-45 years of age in the Human Viral Challenge model. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection
- What is being tested?
- MV-012-968
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Dec 2020to 9 Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- An informed consent document signed and dated by the participant and the Investigator.
- Aged between 18 and 45 years old on the day of signing the consent form.
- In good general health with no history, or current evidence, of clinically significant medical conditions (including respiratory, cardiac and immunodeficiency), and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ECG), and routine laboratory tests as determined by the Investigator.
- A documented medical history prior to enrolment.
- Females of child bearing potential must have a negative pregnancy test prior to enrollment.
- Females and Males must agree to adhere to the highly effective contraceptive requirements of the study from 2 weeks prior to the first study visit until 90 days after the date of study vaccination.
- Sero-suitable to the challenge virus, as defined in the study Analytical Plan.
Who cannot join
- History of symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit
- Rhinitis which is clinically active
- History of moderate to severe rhinitis
- Acute sinusitis during Screening
- Use of corticosteroid in respiratory tract (e.g. nasal or inhaled steroid) in the 30 days leading up to study vaccination
- Females who are breastfeeding or have been pregnant within 6 months prior to the study
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- 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])
- Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test
- Those employed or immediate relatives of those employed at hVIVO or the Sponsor
- Participants may not live or work in direct close contact with, or live with anyone whose work brings them into direct close contact with, children under 2 years of age
- Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Prophylactic Efficacy of MV-012-968 Against Respiratory Syncytial Virus (RSV) Infection in the Virus Challenge Model.
The purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic RSV infection when administered to adults 18-45 years of age in the Human Viral Challenge model.
- Conditions
- RSV Infection
- Being tested
- MV-012-968, Placebo
- Keywords
- RSV, vaccine, live attenuated, intranasal, challenge, Phase 2, safety, efficacy
- 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.
MV-012-968Biological
MV-012-968 is a recombinant, live attenuated RSV vaccine.
PlaceboOther
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| MV-012-968 | Experimental | Dose: 1 x10^6 Plaque Forming Unit (PFU), given intranasally, followed approximately 28 days later by inoculation with RSV-A (Memphis 37b). Receives: Biological: MV-012-968 |
| Placebo | Placebo comparator | Sodium Chloride 0.9% w/v intravenous infusion B.P (Normal Saline) matched to reference article product, given intranasally. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of symptomatic RSV infection, as defined as the occurrence of both:
- At least 1 quantifiable plaque assay sample in nasal wash specimens and
- Symptoms meeting either: (i) a symptom of any grade from 2 different symptom categories from the participant Symptom Diary Card [SDC] (Upper Respiratory, Lower Respiratory, Systemic) or (ii) at least 1 Grade 2 upper or lower respiratory symptom from the participant SDC
Measured: 10 days (days 2 to 12)
Secondary outcomes (12)
Frequency of symptomatic RSV infection, as defined as occurrence of both:
- Two Quantifiable RT-qPCR samples on 2 consecutive days (i.e. at least 1 on each of 2 consecutive days) in nasal wash specimens and
- Symptoms meeting either: (i) a symptom of any grade from 2 different symptom categories from the SDC (Upper Respiratory, Lower Respiratory, Systemic) or (ii) at least 1 Grade 2 upper or lower respiratory symptom from the participant SDC
Measured: 10 days (days 2 to 12)
Frequency of RSV infection, as defined as the occurrence of 2 quantifiable RT-qPCR samples on 2 consecutive days (i.e. at least 1 on each of 2 consecutive days) in nasal wash specimens
Measured: 10 days (Day 2 to 12)
Frequency of RSV infection, as defined as the occurrence of at least 1 quantifiable plaque assay sample in nasal wash specimens
Measured: 10 days (Day 2 to 12)
Mean daily total symptom score using the SDC
Measured: 10 days (Day 2 to 12)
Mean daily weight of nasal (mucus) discharge
Measured: 10 days (Day 2 to 12)
RSV load Area Under the Curve (AUC), as measured by RT-qPCR analysis of nasal wash specimens
Measured: 10 days (Day 2 to 12)
Peak RSV load, as measured by RT-qPCR of nasal wash specimens
Measured: 10 days (Day 2 to 12)
Frequency of solicited adverse events (AEs) as reported in the Subject Vaccination Diary Card, categorized by severity. Solicited AEs are predefined AEs that may occur after study vaccine administration.
Measured: Time Frame: 7 days (Day -28 to -21)
Frequency of unsolicited AEs after study vaccination, categorized by severity and by study vaccine relatedness.
Unsolicited AEs are any untoward medical occurrences in a participant administered the study vaccine, regardless of causal relationship to the study vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the study vaccine.
Measured: 28 days (Day -28 to 0)
Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness.
Measured: 29 days (Day 0 to 28)
Frequency of serious AEs (SAEs) after study vaccination, categorized by study vaccine relatedness.
SAEs are AEs, whether considered causally related to the study vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
Measured: 180 days (Day -28 to 152)
Frequency of medically attended AEs (MAEs) after study vaccination, categorized by study vaccine relatedness.
MAEs are AEs, whether considered causally related to the study vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'checkups', and vaccinations, are not considered MAEs
Measured: 180 days (Day -28 to 152)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start29 Dec 2020
- Primary completion7 May 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meissa Vaccines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hvivo
- Responsible party
- Sponsor
- Investigators
- Mariya Kalinova, MD, Principal investigator, hVIVO Services LtdOliver Medzihradsky, MD MPH MS, Study director, Meissa Vaccines, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690335
- Sponsor's protocol ID
- MV-004
- Other IDs
- 2020-002848-22
- Status last verified
- Aug 2022
- First submitted
- 28 Dec 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Prophylactic Efficacy of MV-012-968 Against Respiratory Syncytial Virus (RSV) Infection in the Virus Challenge Model.
- ClinicalTrials.gov ID
- NCT04690335
- Acronym / sponsor ID
- MV-004
- Conditions
- RSV Infection
- Keywords
- RSV, vaccine, live attenuated, intranasal, challenge, Phase 2, safety, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Meissa Vaccines, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hvivo
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 30 Dec 2020 (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.
The purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic RSV infection when administered to adults 18-45 years of age in the Human Viral Challenge model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MV-012-968 | Experimental | Biological: MV-012-968Dose: 1 x10^6 Plaque Forming Unit (PFU), given intranasally, followed approximately 28 days later by inoculation with RSV-A (Memphis 37b). |
| Placebo | Placebo comparator | Other: PlaceboSodium Chloride 0.9% w/v intravenous infusion B.P (Normal Saline) matched to reference article product, given intranasally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- An informed consent document signed and dated by the participant and the Investigator.
- Aged between 18 and 45 years old on the day of signing the consent form.
- In good general health with no history, or current evidence, of clinically significant medical conditions (including respiratory, cardiac and immunodeficiency), and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ECG), and routine laboratory tests as determined by the Investigator.
- A documented medical history prior to enrolment.
- Females of child bearing potential must have a negative pregnancy test prior to enrollment.
Key exclusion criteria (11 listed)
- History of symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit
- Rhinitis which is clinically active
- History of moderate to severe rhinitis
- Acute sinusitis during Screening
- Use of corticosteroid in respiratory tract (e.g. nasal or inhaled steroid) in the 30 days leading up to study vaccination
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 |
|---|---|---|
| MV-012-968MV-012-968 is a recombinant, live attenuated RSV vaccine. | Biological | MV-012-968 |
| PlaceboSaline solution | Other | Placebo |
Primary outcome
Frequency of symptomatic RSV infection, as defined as the occurrence of both:
Time frame: 10 days (days 2 to 12)
* At least 1 quantifiable plaque assay sample in nasal wash specimens and * Symptoms meeting either: (i) a symptom of any grade from 2 different symptom categories from the participant Symptom Diary Card [SDC] (Upper Respiratory, Lower Respiratory, Systemic) or (ii) at least 1 Grade 2 upper or lower respiratory symptom from the participant SDC
12 secondary outcomes
Frequency of symptomatic RSV infection, as defined as occurrence of both:
Time frame: 10 days (days 2 to 12)
Frequency of RSV infection, as defined as the occurrence of 2 quantifiable RT-qPCR samples on 2 consecutive days (i.e. at least 1 on each of 2 consecutive days) in nasal wash specimens
Time frame: 10 days (Day 2 to 12)
Frequency of RSV infection, as defined as the occurrence of at least 1 quantifiable plaque assay sample in nasal wash specimens
Time frame: 10 days (Day 2 to 12)
Mean daily total symptom score using the SDC
Time frame: 10 days (Day 2 to 12)
Mean daily weight of nasal (mucus) discharge
Time frame: 10 days (Day 2 to 12)
RSV load Area Under the Curve (AUC), as measured by RT-qPCR analysis of nasal wash specimens
Time frame: 10 days (Day 2 to 12)
Peak RSV load, as measured by RT-qPCR of nasal wash specimens
Time frame: 10 days (Day 2 to 12)
Frequency of solicited adverse events (AEs) as reported in the Subject Vaccination Diary Card, categorized by severity. Solicited AEs are predefined AEs that may occur after study vaccine administration.
Time frame: Time Frame: 7 days (Day -28 to -21)
Frequency of unsolicited AEs after study vaccination, categorized by severity and by study vaccine relatedness.
Time frame: 28 days (Day -28 to 0)
Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness.
Time frame: 29 days (Day 0 to 28)
Frequency of serious AEs (SAEs) after study vaccination, categorized by study vaccine relatedness.
Time frame: 180 days (Day -28 to 152)
Frequency of medically attended AEs (MAEs) after study vaccination, categorized by study vaccine relatedness.
Time frame: 180 days (Day -28 to 152)
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 4 Aug 2022.
- 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.
Mariya Kalinova, MD principal investigator
hVIVO Services Ltd
Oliver Medzihradsky, MD MPH MS study director
Meissa Vaccines, Inc.
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 MV-012-968 in people with RSV Infection, run by Meissa Vaccines, Inc. 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 7 inclusion and 11 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 4 Aug 2022. 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?
Frequency of symptomatic RSV infection, as defined as the occurrence of both: (time frame: 10 days (days 2 to 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2022.