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Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children

NCT ID: NCT04444284

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2021-05-07

Brief Summary

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This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.

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Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The first 15 enrolled participants will be assigned to Dosage Group 1 and be randomly allocated to receive either investigational vaccine at Dosage 1 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 1 safety data through Day 14, to allow dosage escalation. The next 15 enrolled participants will be assigned to Dosage Group 2 and be randomly allocated to receive investigational vaccine at Dosage 2 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 2 safety data through Day 14, to allow dosage escalation. The final group (Dosage Group 3) will consist of up to 12 enrolled participants who will be allocated to receive investigational vaccine at Dosage 3.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The study is single-mask in 2 of the 3 dosage groups: study participants and their parent(s)/guardian(s) will not know their child's study assignment, whereas investigators, site staff, and site pharmacists will remain unmasked.

Study Groups

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Dosage Group 1: RSV Vaccine Dosage 1

Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1.

Group Type EXPERIMENTAL

Investigational RSV vaccine MV-012-968 (Dosage 1)

Intervention Type BIOLOGICAL

Single dose administered intranasally on Day 1

Dosage Group 1: Placebo

Participants in this arm will receive a single intranasal dose of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose administered intranasally on Day 1

Dosage Group 2: RSV Vaccine Dosage 2

Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2.

Group Type EXPERIMENTAL

Investigational RSV vaccine MV-012-968 (Dosage 2)

Intervention Type BIOLOGICAL

Single dose administered intranasally on Day 1

Dosage Group 2: Placebo

Participants in this arm will receive a single intranasal dose of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose administered intranasally on Day 1

Dosage Group 3: RSV Vaccine Dosage 3

Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3.

Group Type EXPERIMENTAL

Investigational RSV vaccine MV-012-968 (Dosage 3)

Intervention Type BIOLOGICAL

Single dose administered intranasally on Day 1

Interventions

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Investigational RSV vaccine MV-012-968 (Dosage 1)

Single dose administered intranasally on Day 1

Intervention Type BIOLOGICAL

Investigational RSV vaccine MV-012-968 (Dosage 2)

Single dose administered intranasally on Day 1

Intervention Type BIOLOGICAL

Placebo

Single dose administered intranasally on Day 1

Intervention Type OTHER

Investigational RSV vaccine MV-012-968 (Dosage 3)

Single dose administered intranasally on Day 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Children aged 15-59 months
2. Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
3. Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
4. Written informed consent provided by parent(s)/guardian(s)

Exclusion Criteria

1. Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
2. Known or suspected immunodeficiency
3. Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
4. Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
5. Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 3 months prior to study inoculation, or planned during study period
6. Receipt of an investigational RSV vaccine at any time
7. Any other condition that, in the judgment of the investigator, would be a risk to participant's safety and/or may interfere with study procedures or interpretation of results
Minimum Eligible Age

15 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meissa Vaccines, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Medzihradsky, MD MPH MS

Role: STUDY_DIRECTOR

Meissa Vaccines, Inc.

Locations

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Meridian Clinical Research

Norfolk, Nebraska, United States

Site Status

Meridian Clinical Research

Omaha, Nebraska, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Stobart CC, Rostad CA, Ke Z, Dillard RS, Hampton CM, Strauss JD, Yi H, Hotard AL, Meng J, Pickles RJ, Sakamoto K, Lee S, Currier MG, Moin SM, Graham BS, Boukhvalova MS, Gilbert BE, Blanco JC, Piedra PA, Wright ER, Moore ML. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat Commun. 2016 Dec 21;7:13916. doi: 10.1038/ncomms13916.

Reference Type RESULT
PMID: 28000669 (View on PubMed)

Other Identifiers

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MV-005

Identifier Type: -

Identifier Source: org_study_id

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