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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227210
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227210


Locations
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United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Meissa Vaccines, Inc.
Investigators
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Study Director: Oliver Medzihradsky, MD MPH MS Meissa Vaccines, Inc.
Publications:
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Responsible Party: Meissa Vaccines, Inc.
ClinicalTrials.gov Identifier: NCT04227210    
Other Study ID Numbers: MV-003
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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