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

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ClinicalTrials.gov Identifier: NCT04690335
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : January 14, 2021
Sponsor:
Collaborator:
Hvivo
Information provided by (Responsible Party):
Meissa Vaccines, Inc.

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.

Condition or disease Intervention/treatment Phase
RSV Infection Biological: MV-012-968 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : December 29, 2020
Estimated Primary Completion Date : May 4, 2021
Estimated Study Completion Date : August 28, 2021

Resource links provided by the National Library of Medicine


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).
Biological: MV-012-968
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.
Other: Placebo
Saline solution




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Frequency of symptomatic RSV infection, as defined as occurrence of both: [ Time Frame: 10 days (days 2 to 12) ]
    • 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

  2. 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) ]
  3. 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) ]
  4. Mean daily total symptom score using the SDC [ Time Frame: 10 days (Day 2 to 12) ]
  5. Mean daily weight of nasal (mucus) discharge [ Time Frame: 10 days (Day 2 to 12) ]
  6. 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) ]
  7. Peak RSV load, as measured by RT-qPCR of nasal wash specimens [ Time Frame: 10 days (Day 2 to 12) ]
  8. 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) ]
  9. 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.

  10. Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness. [ Time Frame: 29 days (Day 0 to 28) ]
  11. 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.

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690335


Contacts
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Contact: Mariya Kalinova, MD +44 (0) 7792671745 m.kalinova@hvivo.com
Contact: Kingsley Eze +44 (0) 07876216261 k.eze@hvivo.com

Locations
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United Kingdom
hVIVO Services Ltd Recruiting
London, United Kingdom, E1 2AX
Contact: Mariya Kalinova, MD    +44(0) 7792671745    m.kalinova@hvivo.com   
Sponsors and Collaborators
Meissa Vaccines, Inc.
Hvivo
Investigators
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Principal Investigator: Mariya Kalinova, MD hVIVO Services Ltd
Study Director: Oliver Medzihradsky, MD MPH MS Meissa Vaccines, Inc.
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Responsible Party: Meissa Vaccines, Inc.
ClinicalTrials.gov Identifier: NCT04690335    
Other Study ID Numbers: MV-004
2020-002848-22 ( EudraCT Number )
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Meissa Vaccines, Inc.:
RSV
vaccine
live attenuated
intranasal
challenge
Phase 2
safety
efficacy
Additional relevant MeSH terms:
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Infection
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases