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

• ClinicalTrials.gov Identifier: NCT04227210
• Recruitment Status: Completed
• First Posted: January 13, 2020
• Last Update Posted: September 16, 2020
• Sponsor: Meissa Vaccines, Inc.
• Information provided by (Responsible Party): Meissa Vaccines, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Syncytial Virus Infections	Biological: RSV vaccine MV-012-968 (dosage #1); Biological: RSV vaccine MV-012-968 (dosage #2)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: January 14, 2020
• Actual Primary Completion Date: August 27, 2020
• Actual Study Completion Date: August 27, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Solicited adverse events (AEs) [ Time Frame: 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.
2. Unsolicited AEs [ Time Frame: 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.
3. Serious adverse events (SAEs) [ Time Frame: 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.
4. Medically attended adverse events (MAEs) [ Time Frame: 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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Kansas

Johnson County Clin-Trials

Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

Meissa Vaccines, Inc.

Investigators

• Study Director: Oliver Medzihradsky, MD MPH MS; Meissa Vaccines, Inc.

More Information

Publications:

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.

• Responsible Party: Meissa Vaccines, Inc.
• ClinicalTrials.gov Identifier: NCT04227210
• Other Study ID Numbers: MV-003
• First Posted: January 13, 2020
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meissa Vaccines, Inc.:

vaccine; live attenuated; safety; immunogenicity; viral shedding; phase 1 clinical trial

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections; Virus Diseases; Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs