Clinical trial NCT04227210: Safety and Immune Response to an Investigational Vaccine Against Respiratory Syncytial Virus in Healthy Adults
Official title: A Phase 1 Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: vaccine
live attenuated
safety
immunogenicity
viral shedding
phase 1 clinical trial
Lead sponsor: Meissa Vaccines, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Solicited adverse events (AEs)
timeFrame: Immediate post-vaccination period
measure: Unsolicited AEs
timeFrame: Immediate post-vaccination period
measure: Serious adverse events (SAEs)
timeFrame: Vaccination through study completion, an average of 6 months
measure: Medically attended adverse events (MAEs)
timeFrame: Vaccination through study completion, an average of 6 months
Secondary outcomes:
measure: Change in serum RSV-specific neutralizing antibody (nAb) titers
timeFrame: Baseline through study completion, an average of 6 months
measure: Change in serum RSV F-specific binding antibody titers
timeFrame: Baseline through study completion, an average of 6 months
measure: Change in mucosal RSV F-specific binding antibody titers
timeFrame: Baseline through study completion, an average of 6 months
measure: Potential vaccine virus shedding
timeFrame: Baseline through 2 months
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
Study officials:
affiliation: Meissa Vaccines, Inc.
name: Oliver Medzihradsky, MD MPH MS
role: STUDY_DIRECTOR
References:
citation: Stobart CC, Rostad CA, Ke Z, Dillard RS, Hampton CM, Strauss JD, Yi H, Hotard AL, Meng J, Pickles RJ, Sakamoto K, Lee S, Currier MG, Moin SM, Graham BS, Boukhvalova MS, Gilbert BE, Blanco JC, Piedra PA, Wright ER, Moore ML. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat Commun. 2016 Dec 21;7:13916. doi: 10.1038/ncomms13916.