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

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227210
• Other study ID #: MV-003
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2020
• Est. completion date: August 27, 2020

Study information

• Verified date: September 2020
• Source: Meissa Vaccines, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Biological:
• RSV vaccine MV-012-968 (dosage #1)
Single dose administered intranasally on Day 1
• RSV vaccine MV-012-968 (dosage #2)
Single dose administered intranasally on Day 1

Locations

Country	Name	City	State
United States	Johnson County Clin-Trials	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Meissa Vaccines, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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