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

Meissa Vaccines

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Biological: Investigational RSV vaccine MV-012-968 (Dosage 1); Biological: Investigational RSV vaccine MV-012-968 (Dosage 2); Biological: Investigational RSV vaccine MV-012-968 (Dosage 3); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04444284

MV-005

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 15 to 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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)

Key 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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34 participants in 5 patient groups, including a placebo group

Dosage Group 1: RSV Vaccine Dosage 1

Experimental group

Description:

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

Treatment:

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

Dosage Group 1: Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Dosage Group 2: RSV Vaccine Dosage 2

Experimental group

Description:

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

Treatment:

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

Dosage Group 2: Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Dosage Group 3: RSV Vaccine Dosage 3

Experimental group

Description:

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

Treatment:

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