- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690335
Human Challenge Study to Evaluate the Efficacy of MV-012-968 Vaccine
August 1, 2022 updated by: Meissa Vaccines, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, E1 2AX
- hVIVO Services Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MV-012-968
Dose: 1 x10^6 Plaque Forming Unit (PFU), given intranasally, followed approximately 28 days later by inoculation with RSV-A (Memphis 37b).
|
MV-012-968 is a recombinant, live attenuated RSV vaccine.
|
PLACEBO_COMPARATOR: Placebo
Sodium Chloride 0.9% w/v intravenous infusion B.P (Normal Saline) matched to reference article product, given intranasally.
|
Saline solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of symptomatic RSV infection, as defined as the occurrence of both:
Time Frame: 10 days (days 2 to 12)
|
|
10 days (days 2 to 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of symptomatic RSV infection, as defined as occurrence of both:
Time Frame: 10 days (days 2 to 12)
|
|
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)
|
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)
|
10 days (Day 2 to 12)
|
|
Mean daily total symptom score using the SDC
Time Frame: 10 days (Day 2 to 12)
|
10 days (Day 2 to 12)
|
|
Mean daily weight of nasal (mucus) discharge
Time Frame: 10 days (Day 2 to 12)
|
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)
|
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)
|
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)
|
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)
|
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.
|
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)
|
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)
|
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.
|
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)
|
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
|
180 days (Day -28 to 152)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mariya Kalinova, MD, hVIVO Services Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 29, 2020
Primary Completion (ACTUAL)
May 7, 2021
Study Completion (ACTUAL)
September 9, 2021
Study Registration Dates
First Submitted
December 28, 2020
First Submitted That Met QC Criteria
December 28, 2020
First Posted (ACTUAL)
December 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 4, 2022
Last Update Submitted That Met QC Criteria
August 1, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MV-004
- 2020-002848-22 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on RSV Infection
-
Biota Pharma Europe LimitedCompletedRespiratory Syncytial Virus (RSV) InfectionUnited Kingdom
-
Gilead SciencesCompletedRespiratory Syncytial Virus (RSV)United States, Belgium, Canada, Netherlands, Australia, Germany, United Kingdom, France
-
Institute for Clinical Effectiveness, JapanGlaxoSmithKlineRecruitingAcute Disease | Respiratory Syncytial Virus (RSV) | Respiratory Viral InfectionJapan
-
Imperial College LondonRecruitingRSV InfectionUnited Kingdom
-
Bavarian NordicCompletedRSV InfectionUnited Kingdom
-
Enanta Pharmaceuticals, InchVIVO Services LimitedCompleted
-
HvivoGlaxoSmithKlineCompleted
-
Hospices Civils de LyonUnknownRespiratory Syncytial Virus Infections | RSV Infection | Syncytial Virus Respiratory Infection | RSV Bronchiolitis
-
Enanta Pharmaceuticals, IncRecruitingRSV InfectionUnited States, Poland, Spain, Taiwan, Bulgaria, Argentina, Puerto Rico, Czechia, Brazil, Israel, Malaysia, Netherlands, Slovakia, South Africa
-
Enanta Pharmaceuticals, InchVIVO Services LimitedRecruiting
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States