Human Challenge Study to Evaluate the Efficacy of MV-012-968 Vaccine

RSV Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690335
• Other study ID #: MV-004
• Secondary ID: 2020-002848-22
• Status: Completed
• Phase: Phase 2
• Start date: December 29, 2020
• Est. completion date: September 9, 2021

Study information

• Verified date: August 2022
• Source: Meissa Vaccines, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 9, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

Biological:
• MV-012-968
MV-012-968 is a recombinant, live attenuated RSV vaccine.

Other:
• Placebo
Saline solution

Locations

Country	Name	City	State
United Kingdom	hVIVO Services Ltd	London

Sponsors (2)

Lead Sponsor	Collaborator
Meissa Vaccines, Inc.	Hvivo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 days (days 2 to 12)
Secondary	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	10 days (days 2 to 12)
Secondary	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		10 days (Day 2 to 12)
Secondary	Frequency of RSV infection, as defined as the occurrence of at least 1 quantifiable plaque assay sample in nasal wash specimens		10 days (Day 2 to 12)
Secondary	Mean daily total symptom score using the SDC		10 days (Day 2 to 12)
Secondary	Mean daily weight of nasal (mucus) discharge		10 days (Day 2 to 12)
Secondary	RSV load Area Under the Curve (AUC), as measured by RT-qPCR analysis of nasal wash specimens		10 days (Day 2 to 12)
Secondary	Peak RSV load, as measured by RT-qPCR of nasal wash specimens		10 days (Day 2 to 12)
Secondary	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: 7 days (Day -28 to -21)
Secondary	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.	28 days (Day -28 to 0)
Secondary	Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness.		29 days (Day 0 to 28)
Secondary	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.	180 days (Day -28 to 152)
Secondary	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	180 days (Day -28 to 152)