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

NCT ID: NCT04690335

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-29
• Study Completion Date: 2021-09-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

MV-012-968

Intervention Type: BIOLOGICAL

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline solution

Interventions

MV-012-968

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

Intervention Type: BIOLOGICAL

Placebo

Saline solution

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hvivo

INDUSTRY

Sponsor Role: collaborator

Meissa Vaccines, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariya Kalinova, MD

Role: PRINCIPAL_INVESTIGATOR

hVIVO Services Ltd

Oliver Medzihradsky, MD MPH MS

Role: STUDY_DIRECTOR

Meissa Vaccines, Inc.

Locations

hVIVO Services Ltd

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2020-002848-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MV-004

Identifier Type: -

Identifier Source: org_study_id