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

NCT04690335 | Completed Phase 2 FDA Drug

• 2 other identifiers: MV-0042020-002848-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

RSV Infection

Keywords

RSV; vaccine; live attenuated; intranasal; challenge; Phase 2; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Frequency of symptomatic RSV infection, as defined as occurrence of both:

  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

  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

  10 days (Day 2 to 12)

• Mean daily total symptom score using the SDC

  10 days (Day 2 to 12)

• Mean daily weight of nasal (mucus) discharge

  10 days (Day 2 to 12)

Study Arms (2)

MV-012-968

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

MV-012-968 BIOLOGICAL

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

MV-012-968

Placebo OTHER

Saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Meissa Vaccines, Inc.: lead
• Hvivo: collaborator

Study Sites (1)

hVIVO Services Ltd

London, E1 2AX, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Mariya Kalinova, MD

  hVIVO Services Ltd

  PRINCIPAL INVESTIGATOR

• Oliver Medzihradsky, MD MPH MS

  Meissa Vaccines, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 30, 2020
• Study Start: December 29, 2020
• Primary Completion: May 7, 2021
• Study Completion: September 9, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)