Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Biological: RSV vaccine MV-012-968 (dosage #1)Biological: RSV vaccine MV-012-968 (dosage #2)
- Registration Number
- NCT04227210
- Lead Sponsor
- Meissa Vaccines, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RSV Vaccine: Dosage Group #1 RSV vaccine MV-012-968 (dosage #1) Participants in this group will receive a single dose of the RSV vaccine at dosage #1 RSV Vaccine: Dosage Group #2 RSV vaccine MV-012-968 (dosage #2) Participants in this group will receive a single dose of the RSV vaccine at dosage #2
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Johnson County Clin-Trials
🇺🇸Lenexa, Kansas, United States