Respiratory Syncytial Virus Infections
Conditions
Keywords
vaccine, live attenuated, safety, immunogenicity, viral shedding, phase 1 clinical trial
Brief summary
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.
Interventions
BIOLOGICALRSV vaccine MV-012-968 (dosage #1)
Single dose administered intranasally on Day 1
BIOLOGICALRSV vaccine MV-012-968 (dosage #2)
Single dose administered intranasally on Day 1
Sponsors
Meissa Vaccines, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medically attended adverse events (MAEs) | Vaccination through study completion, an average of 6 months | 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. |
| Solicited adverse events (AEs) | Immediate post-vaccination period | Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that can occur after vaccine administration. |
| Unsolicited AEs | Immediate post-vaccination period | 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. |
| Serious adverse events (SAEs) | Vaccination through study completion, an average of 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum RSV-specific neutralizing antibody (nAb) titers | Baseline through study completion, an average of 6 months | Post-vaccination change in serum RSV-specific nAb titers will be measured per participant. |
| Change in serum RSV F-specific binding antibody titers | Baseline through study completion, an average of 6 months | Post-vaccination change in serum RSV F-specific binding antibody titers will be measured per participant. |
| Change in mucosal RSV F-specific binding antibody titers | Baseline through study completion, an average of 6 months | Post-vaccination change in mucosal RSV F-specific binding antibody titers will be measured per participant. |
| Potential vaccine virus shedding | Baseline through 2 months | The presence and, if detected, quantity and duration of any shed vaccine virus will be measured per participant. |
Countries
United States
Outcome results
None listed