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

NCT04227210 | Completed Phase 1 FDA Drug

• 1 other identifier: MV-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Change in serum RSV-specific neutralizing antibody (nAb) titers

  Baseline through study completion, an average of 6 months

• Change in serum RSV F-specific binding antibody titers

  Baseline through study completion, an average of 6 months

• Change in mucosal RSV F-specific binding antibody titers

  Baseline through study completion, an average of 6 months

• Potential vaccine virus shedding

  Baseline through 2 months

Study Arms (2)

RSV Vaccine: Dosage Group #1

EXPERIMENTAL

Participants in this group will receive a single dose of the RSV vaccine at dosage #1

Biological: RSV vaccine MV-012-968 (dosage #1)

RSV Vaccine: Dosage Group #2

EXPERIMENTAL

Participants in this group will receive a single dose of the RSV vaccine at dosage #2

Biological: RSV vaccine MV-012-968 (dosage #2)

Interventions

RSV vaccine MV-012-968 (dosage #1) BIOLOGICAL

Single dose administered intranasally on Day 1

RSV Vaccine: Dosage Group #1

RSV vaccine MV-012-968 (dosage #2) BIOLOGICAL

Single dose administered intranasally on Day 1

RSV Vaccine: Dosage Group #2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meissa Vaccines, Inc.: lead

Study Sites (1)

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Related 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.

  PMID: 28000669 BACKGROUND

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Oliver Medzihradsky, MD MPH MS

  Meissa Vaccines, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: January 14, 2020
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)