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

Primary Purpose

RSV Infection

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
MV-012-968
Placebo
Sponsored by
Meissa Vaccines, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for RSV Infection focused on measuring RSV, vaccine, live attenuated, intranasal, challenge, Phase 2, safety, efficacy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • hVIVO Services Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MV-012-968

Placebo

Arm Description

Dose: 1 x10^6 Plaque Forming Unit (PFU), given intranasally, followed approximately 28 days later by inoculation with RSV-A (Memphis 37b).

Sodium Chloride 0.9% w/v intravenous infusion B.P (Normal Saline) matched to reference article product, given intranasally.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Frequency of RSV infection, as defined as the occurrence of at least 1 quantifiable plaque assay sample in nasal wash specimens
Mean daily total symptom score using the SDC
Mean daily weight of nasal (mucus) discharge
RSV load Area Under the Curve (AUC), as measured by RT-qPCR analysis of nasal wash specimens
Peak RSV load, as measured by RT-qPCR of nasal wash specimens
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.
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.
Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness.
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.
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

Full Information

First Posted
December 28, 2020
Last Updated
August 1, 2022
Sponsor
Meissa Vaccines, Inc.
Collaborators
Hvivo
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1. Study Identification

Unique Protocol Identification Number
NCT04690335
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meissa Vaccines, Inc.
Collaborators
Hvivo

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSV Infection
Keywords
RSV, vaccine, live attenuated, intranasal, challenge, Phase 2, safety, efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MV-012-968
Arm Type
Experimental
Arm Description
Dose: 1 x10^6 Plaque Forming Unit (PFU), given intranasally, followed approximately 28 days later by inoculation with RSV-A (Memphis 37b).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sodium Chloride 0.9% w/v intravenous infusion B.P (Normal Saline) matched to reference article product, given intranasally.
Intervention Type
Biological
Intervention Name(s)
MV-012-968
Intervention Description
MV-012-968 is a recombinant, live attenuated RSV vaccine.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline solution
Primary Outcome Measure Information:
Title
Frequency of symptomatic RSV infection, as defined as the occurrence of both:
Description
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
Time Frame
10 days (days 2 to 12)
Secondary Outcome Measure Information:
Title
Frequency of symptomatic RSV infection, as defined as occurrence of both:
Description
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
Time Frame
10 days (days 2 to 12)
Title
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)
Title
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)
Title
Mean daily total symptom score using the SDC
Time Frame
10 days (Day 2 to 12)
Title
Mean daily weight of nasal (mucus) discharge
Time Frame
10 days (Day 2 to 12)
Title
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)
Title
Peak RSV load, as measured by RT-qPCR of nasal wash specimens
Time Frame
10 days (Day 2 to 12)
Title
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)
Title
Frequency of unsolicited AEs after study vaccination, categorized by severity and by study vaccine relatedness.
Description
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.
Time Frame
28 days (Day -28 to 0)
Title
Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness.
Time Frame
29 days (Day 0 to 28)
Title
Frequency of serious AEs (SAEs) after study vaccination, categorized by study vaccine relatedness.
Description
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.
Time Frame
180 days (Day -28 to 152)
Title
Frequency of medically attended AEs (MAEs) after study vaccination, categorized by study vaccine relatedness.
Description
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
Time Frame
180 days (Day -28 to 152)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariya Kalinova, MD
Organizational Affiliation
hVIVO Services Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oliver Medzihradsky, MD MPH MS
Organizational Affiliation
Meissa Vaccines, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
hVIVO Services Ltd
City
London
ZIP/Postal Code
E1 2AX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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