Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months

Meissa Vaccines

Status and phase: Enrolling; Phase 1

Conditions: Respiratory Syncytial Virus (RSV)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04909021

MV-006

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 a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to RSV.

Enrollment: 63 estimated patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Children aged 6-36 months
2. Good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease
3. Seronegative to RSV, as defined by serum nAb titer below the threshold described in the study protocol and operations manual
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), genetic or metabolic, hepatic, renal, infectious (including recurrent or chronic sinusitis), or immunodeficiency
2. Prior lab-confirmed RSV infection
3. Household or close contact (including but not limited to daycare) during the 21 days post-inoculation with anyone < 6 months old or immunocompromised (applies to first study inoculation)
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 6 months prior to study inoculation, or planned use 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 subject'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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63 participants in 6 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 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 3: RSV Vaccine Dosage 3 (Single-dose)

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; single-dose)

Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose)

Experimental group

Description:

Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 followed by a second identical dose of the investigational RSV vaccine 28 days later

Treatment:

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

Placebo (Single-dose)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo (single-dose)

Placebo (Two-dose)

Placebo Comparator group

Description:

Participants in this arm will receive a single intranasal dose of placebo followed by a second identical dose of placebo 28 days later

Treatment:

Other: Placebo (two-dose)