Clinical trial NCT04690335: Human Challenge Study to Evaluate the Efficacy of MV-012-968 Vaccine
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: RSV Infection
Keywords: RSV
vaccine
live attenuated
intranasal
challenge
Phase 2
safety
efficacy
Lead sponsor: Meissa Vaccines, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hvivo
First posted: 2020-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Key Inclusion Criteria:

1. An informed consent document signed and dated by the participant and the Investigator.
2. Aged between 18 and 45 years old on the day of signing the consent form.
3. 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.
4. A documented medical history prior to enrolment.
5. Females of child bearing potential must have a negative pregnancy test prior to enrollment.
6. 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.
7. Sero-suitable to the challenge virus, as defined in the study Analytical Plan.

Exclusion Criteria:

1. History of symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit
2. Rhinitis which is clinically active
3. History of moderate to severe rhinitis
4. Acute sinusitis during Screening
5. Use of corticosteroid in respiratory tract (e.g. nasal or inhaled steroid) in the 30 days leading up to study vaccination
6. Females who are breastfeeding or have been pregnant within 6 months prior to the study
7. Participants who have smoked ≥ 10 pack years at any time \[10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years\])
8. Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test
9. Those employed or immediate relatives of those employed at hVIVO or the Sponsor
10. 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
11. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study

Primary outcomes:
measure: Frequency of symptomatic RSV infection, as defined as the occurrence of both:
timeFrame: 10 days (days 2 to 12)
Secondary outcomes:
measure: Frequency of symptomatic RSV infection, as defined as occurrence of both:
timeFrame: 10 days (days 2 to 12)
measure: 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
timeFrame: 10 days (Day 2 to 12)
measure: Frequency of RSV infection, as defined as the occurrence of at least 1 quantifiable plaque assay sample in nasal wash specimens
timeFrame: 10 days (Day 2 to 12)
measure: Mean daily total symptom score using the SDC
timeFrame: 10 days (Day 2 to 12)
measure: Mean daily weight of nasal (mucus) discharge
timeFrame: 10 days (Day 2 to 12)
measure: RSV load Area Under the Curve (AUC), as measured by RT-qPCR analysis of nasal wash specimens
timeFrame: 10 days (Day 2 to 12)
measure: Peak RSV load, as measured by RT-qPCR of nasal wash specimens
timeFrame: 10 days (Day 2 to 12)
measure: 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.
timeFrame: Time Frame: 7 days (Day -28 to -21)
measure: Frequency of unsolicited AEs after study vaccination, categorized by severity and by study vaccine relatedness.
timeFrame: 28 days (Day -28 to 0)
measure: Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness.
timeFrame: 29 days (Day 0 to 28)
measure: Frequency of serious AEs (SAEs) after study vaccination, categorized by study vaccine relatedness.
timeFrame: 180 days (Day -28 to 152)
measure: Frequency of medically attended AEs (MAEs) after study vaccination, categorized by study vaccine relatedness.
timeFrame: 180 days (Day -28 to 152)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: hVIVO Services Ltd
Study officials:
affiliation: hVIVO Services Ltd
name: Mariya Kalinova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meissa Vaccines, Inc.
name: Oliver Medzihradsky, MD MPH MS
role: STUDY_DIRECTOR
References: