Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults

Study Overview
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Brief Summary
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This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.

Official Title
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A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Biological: RSV vaccine MV-012-968 (dosage #1)
* Biological: RSV vaccine MV-012-968 (dosage #2)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Adult 18-40 years of age In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease RSV 'sero-low' from a pre-vaccination serum sample Signed informed consent form Exclusion Criteria: Occupational or household exposure to children < 5 years of age, or to immunocompromised individuals Prior receipt of an investigational RSV vaccine Women who are pregnant, lactating, or unwilling to take effective measures to prevent pregnancy for at least 3 months after vaccination Any other reason the Investigator considers exclusionary

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each enrolled subject will be allocated to 1 of 2 study groups. Group 1 will receive one dosage of the investigational RSV vaccine, and Group 2 will receive a different dosage of the same vaccine.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSV Vaccine: Dosage Group #1<br>Participants in this group will receive a single dose of the RSV vaccine at dosage #1 | Biological: RSV vaccine MV-012-968 (dosage #1)<br>* Single dose administered intranasally on Day 1<br>|
| Experimental: RSV Vaccine: Dosage Group #2<br>Participants in this group will receive a single dose of the RSV vaccine at dosage #2 | Biological: RSV vaccine MV-012-968 (dosage #2)<br>* Single dose administered intranasally on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited adverse events (AEs) | Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that can occur after vaccine administration. | Immediate post-vaccination period | 
| Unsolicited AEs | Frequency of unsolicited AEs will be measured, categorized by severity. Unsolicited AEs are any untoward medical occurrences in a participant administered the investigational vaccine, regardless of causal relationship to the investigational vaccine. Unsolicited AEs can include unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of the investigational vaccine. | Immediate post-vaccination period | 
| Serious adverse events (SAEs) | Frequency of SAEs will be measured, categorized by vaccine-relatedness. SAEs are AEs, whether considered causally related to the investigational vaccine or not, that threaten life or result in any of the following: death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect. | Vaccination through study completion, an average of 6 months | 
| Medically attended adverse events (MAEs) | Frequency of MAEs will be measured, categorized by vaccine-relatedness. MAEs are AEs, whether considered causally related to the investigational vaccine or not, with unscheduled medically attended visits, such as urgent care visits, acute primary care visits, emergency department visits, or other previously unplanned visits to a medical provider. Scheduled medical visits such as routine physicals, wellness checks, 'check-ups', and vaccinations, are not considered MAEs. | Vaccination through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum RSV-specific neutralizing antibody (nAb) titers | Post-vaccination change in serum RSV-specific nAb titers will be measured per participant. | Baseline through study completion, an average of 6 months | 
| Change in serum RSV F-specific binding antibody titers | Post-vaccination change in serum RSV F-specific binding antibody titers will be measured per participant. | Baseline through study completion, an average of 6 months | 
| Change in mucosal RSV F-specific binding antibody titers | Post-vaccination change in mucosal RSV F-specific binding antibody titers will be measured per participant. | Baseline through study completion, an average of 6 months | 
| Potential vaccine virus shedding | The presence and, if detected, quantity and duration of any shed vaccine virus will be measured per participant. | Baseline through 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, live attenuated, safety, immunogenicity, viral shedding, phase 1 clinical trial