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Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months

Primary Purpose

Respiratory Syncytial Virus (RSV)

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Investigational RSV vaccine MV-012-968 (Dosage 1)
Investigational RSV vaccine MV-012-968 (Dosage 2)
Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)
Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)
Placebo (single-dose)
Placebo (two-dose)
Sponsored by
Meissa Vaccines, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus (RSV) focused on measuring live attenuated vaccine, safety, immunogenicity, Phase 1 clinical trial, Pediatric, seronegative, children

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  1. Children aged 6-36 months
  2. Good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease
  3. Seronegative to RSV, as defined by serum nAb titer below the threshold described in the study protocol and operations manual
  4. Written informed consent provided by parent(s)/guardian(s)

Key Exclusion Criteria:

  1. Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), genetic or metabolic, hepatic, renal, infectious (including recurrent or chronic sinusitis), or immunodeficiency
  2. Prior lab-confirmed RSV infection
  3. Household or close contact (including but not limited to daycare) during the 21 days post-inoculation with anyone < 6 months old or immunocompromised (applies to first study inoculation)
  4. Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
  5. Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 6 months prior to study inoculation, or planned use during study period
  6. Receipt of an investigational RSV vaccine at any time
  7. Any other condition that, in the judgment of the investigator, would be a risk to subject's safety and/or may interfere with study procedures or interpretation of results

Sites / Locations

  • MedPharmicsRecruiting
  • Paradigm Clinical Research
  • The Emory Children's CenterRecruiting
  • Clinical Research Prime
  • MedPharmicsRecruiting
  • Meridian Clinical Research
  • Meridian Clinical ResearchRecruiting
  • Meridian Clinical ResearchRecruiting
  • Aventiv Research
  • Coastal Pediatric Research
  • PanAmerican Clinical Research
  • Benchmark ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Dosage Group 1: RSV Vaccine Dosage 1

Dosage Group 2: RSV Vaccine Dosage 2

Dosage Group 3: RSV Vaccine Dosage 3 (Single-dose)

Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose)

Placebo (Single-dose)

Placebo (Two-dose)

Arm Description

Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1

Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2

Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3

Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 followed by a second identical dose of the investigational RSV vaccine 28 days later

Participants in this arm will receive a single intranasal dose of placebo

Participants in this arm will receive a single intranasal dose of placebo followed by a second identical dose of placebo 28 days later

Outcomes

Primary Outcome Measures

Solicited adverse events (AEs)
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration
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.
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.
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.
Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)
Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.

Secondary Outcome Measures

Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations
Change in serum binding (RSV F-specific) IgG concentrations will be measured per participant
Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations
Change in nasal mucosal binding (RSV F-specific) IgA concentrations will be measured per participant
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency
Frequency of any post-vaccination shedding of vaccine virus (as detected by plaque assay) after a single intranasal dose of MV-012-968 will be measured per dosage group and overall.
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude
If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration
If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, duration of shedding (in days) will be measured per dosage group and overall.

Full Information

First Posted
May 26, 2021
Last Updated
August 1, 2022
Sponsor
Meissa Vaccines, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04909021
Brief Title
Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
Official Title
Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1c Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine (MV-012-968) in Seronegative Children 6-36 Months
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meissa Vaccines, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to RSV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus (RSV)
Keywords
live attenuated vaccine, safety, immunogenicity, Phase 1 clinical trial, Pediatric, seronegative, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
1st 5 subjects will be in Group 1 and randomized to investigational vaccine (IP) Dosage 1 or placebo. Safety Monitoring Committee (SMC) will review Group 1 data to Day 15 to allow dose escalation. Next 10 subjects will be in Group 2 and randomized to IP Dosage 2 or placebo. SMC will review Group 2 data to Day 15 to allow dose escalation. Next 12 enrolled subjects will be in Group 3 and randomized to IP Dosage 3 or placebo. SMC will review Group 3 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 4 and randomized to IP Dosage 4 or placebo. SMC will review Group 4 data to Day 15 to allow dose escalation. Next 12 subjects will be in Group 3a and randomized to IP Dosage 3 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose. Final 12 subjects will be in Group 4a and randomized to IP Dosage 4 or placebo; if meet criteria will receive 2nd dose IP or placebo 28 days after 1st dose.
Masking
Participant
Masking Description
The study is single-mask. Study participants and their parent(s)/guardian(s) will not know their child's study assignment; investigators, site staff, and site pharmacists will remain unmasked.
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dosage Group 1: RSV Vaccine Dosage 1
Arm Type
Experimental
Arm Description
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 1
Arm Title
Dosage Group 2: RSV Vaccine Dosage 2
Arm Type
Experimental
Arm Description
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 2
Arm Title
Dosage Group 3: RSV Vaccine Dosage 3 (Single-dose)
Arm Type
Experimental
Arm Description
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3
Arm Title
Dosage Group 3a: RSV Vaccine Dosage 3 (Two-dose)
Arm Type
Experimental
Arm Description
Participants in this arm will receive a single intranasal dose of the investigational RSV vaccine at Dosage 3 followed by a second identical dose of the investigational RSV vaccine 28 days later
Arm Title
Placebo (Single-dose)
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive a single intranasal dose of placebo
Arm Title
Placebo (Two-dose)
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive a single intranasal dose of placebo followed by a second identical dose of placebo 28 days later
Intervention Type
Biological
Intervention Name(s)
Investigational RSV vaccine MV-012-968 (Dosage 1)
Intervention Description
Single dose administered intranasally on Day 1
Intervention Type
Biological
Intervention Name(s)
Investigational RSV vaccine MV-012-968 (Dosage 2)
Intervention Description
Single dose administered intranasally on Day 1
Intervention Type
Biological
Intervention Name(s)
Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)
Intervention Description
Single dose administered intranasally on Day 1
Intervention Type
Biological
Intervention Name(s)
Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)
Intervention Description
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
Intervention Type
Other
Intervention Name(s)
Placebo (single-dose)
Intervention Description
Single dose administered intranasally on Day 1
Intervention Type
Other
Intervention Name(s)
Placebo (two-dose)
Intervention Description
Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
Primary Outcome Measure Information:
Title
Solicited adverse events (AEs)
Description
Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration
Time Frame
Immediate post-vaccination period
Title
Unsolicited AEs
Description
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.
Time Frame
Immediate post-vaccination period
Title
Serious adverse events (SAEs)
Description
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.
Time Frame
Full study duration, an average of 1 year
Title
Medically attended adverse events (MAEs)
Description
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.
Time Frame
Full study duration, an average of 1 year
Title
Change in RSV-specific serum neutralizing antibody (nAb) titers (GMT)
Description
Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.
Time Frame
Baseline through Day 28, an average of six (6) weeks
Secondary Outcome Measure Information:
Title
Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations
Description
Change in serum binding (RSV F-specific) IgG concentrations will be measured per participant
Time Frame
Baseline through Day 28, an average of six (6) weeks
Title
Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations
Description
Change in nasal mucosal binding (RSV F-specific) IgA concentrations will be measured per participant
Time Frame
Baseline through Day 28, an average of six (6) weeks
Title
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency
Description
Frequency of any post-vaccination shedding of vaccine virus (as detected by plaque assay) after a single intranasal dose of MV-012-968 will be measured per dosage group and overall.
Time Frame
Intranasal inoculation through Day 22, an average of three (3) weeks
Title
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude
Description
If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall
Time Frame
Intranasal inoculation through Day 22, an average of three (3) weeks
Title
Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration
Description
If post-vaccination shedding of vaccine virus is detected by plaque assay after a single intranasal dose of MV-012-968, duration of shedding (in days) will be measured per dosage group and overall.
Time Frame
Intranasal inoculation through Day 22, an average of three (3) weeks
Other Pre-specified Outcome Measures:
Title
RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation
Description
Frequency of RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation will be measured, categorized by severity.
Time Frame
Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology
Title
RSV-confirmed medically attended acute lower respiratory infection
Description
Frequency of RSV-confirmed medically attended acute lower respiratory infection during peak RSV season following study inoculation will be measured, categorized by severity.
Time Frame
Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Children aged 6-36 months Good health based on history, physical examination, and medical record review, without evidence or suspicion of chronic disease Seronegative to RSV, as defined by serum nAb titer below the threshold described in the study protocol and operations manual Written informed consent provided by parent(s)/guardian(s) Key Exclusion Criteria: Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), genetic or metabolic, hepatic, renal, infectious (including recurrent or chronic sinusitis), or immunodeficiency Prior lab-confirmed RSV infection Household or close contact (including but not limited to daycare) during the 21 days post-inoculation with anyone < 6 months old or immunocompromised (applies to first study inoculation) Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes) Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 6 months prior to study inoculation, or planned use during study period Receipt of an investigational RSV vaccine at any time Any other condition that, in the judgment of the investigator, would be a risk to subject's safety and/or may interfere with study procedures or interpretation of results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jay Lieberman, MD
Phone
3107538943
Email
jay.lieberman@meissavaccines.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Lieberman, MD
Organizational Affiliation
Meissa Vaccines, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
MedPharmics
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Wallace
Phone
602-368-1928
Email
JasonWallace@medpharmics.co
First Name & Middle Initial & Last Name & Degree
Charles S Plimpton, MD
Facility Name
Paradigm Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Howlett
Phone
858-274-4226
Email
jhowlett@paradigm-research.com
First Name & Middle Initial & Last Name & Degree
Andrea VanDucen
Phone
858-274-4226
Email
avanducen@paradigm-research.com
First Name & Middle Initial & Last Name & Degree
Shaun Berger, MD
Facility Name
The Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Macoy
Phone
404-727-8440
Email
lisa.simmons.macoy@emory.edu
First Name & Middle Initial & Last Name & Degree
Evan J Anderson, MD
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireya Martinez
Phone
208-497-0600
Ext
124
Email
mireya@crprime.com
First Name & Middle Initial & Last Name & Degree
Karley Morgan
Phone
208-497-0600
Email
karley@crprime.com
First Name & Middle Initial & Last Name & Degree
Jeffrey B Baker, MD
Facility Name
MedPharmics
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katelyn Jackson
Phone
504-304-7197
Email
katelynvinet@medpharmics.com
First Name & Middle Initial & Last Name & Degree
Robert J Jeanfreau, MD
Facility Name
Meridian Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda D Stahr
Phone
402-407-2800
Email
mstahr@mcrmed.com
First Name & Middle Initial & Last Name & Degree
Kristine Johnson
Phone
402-407-2800
Email
krjohnson@mcrmed.com
First Name & Middle Initial & Last Name & Degree
Daniel J Leonard, MD
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Nichols
Phone
402-933-6500
Email
ANichols@mcrmed.com
First Name & Middle Initial & Last Name & Degree
Brandon Essink, MD
Facility Name
Meridian Clinical Research
City
Binghamton
State/Province
New York
ZIP/Postal Code
41348
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathe Olmstead
Phone
607-771-1064
Ext
41348
Email
KOlmstead@mcrmed.com
First Name & Middle Initial & Last Name & Degree
Frank Eder, MD
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheyanne Wilson
Phone
614-501-6164
Ext
2022
Email
cwilson@aventivresearch.com
First Name & Middle Initial & Last Name & Degree
Logan Aldrich
Phone
614-501-6164
Ext
3009
Email
sgaines@aventivresearch.co
First Name & Middle Initial & Last Name & Degree
Samir Arora, MD
Facility Name
Coastal Pediatric Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathew Thomas
Phone
843-518-5646
Email
mthomas@cpakids.com
First Name & Middle Initial & Last Name & Degree
Emily McCoy
Phone
843-737-9471
Email
emccoy@cpakids.com
First Name & Middle Initial & Last Name & Degree
Stephen W Stripling, MD
Facility Name
PanAmerican Clinical Research
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis E Magana
Phone
956-443-0016
Email
lmagana@panamclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Patricia Garza
Phone
956-443-0016
Email
pgarza@panamclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Christopher Romero, MD
Facility Name
Benchmark Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaudohn Hicks
Phone
210-697-3600
Ext
6
Email
jaudohnhicks@benchmarkresearch.net
First Name & Middle Initial & Last Name & Degree
April Valdvieso
Phone
210-697-3600
Ext
6
Email
aprilvaldvieso@benchmarkresearch.net
First Name & Middle Initial & Last Name & Degree
Olutola Adetona, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28000669
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.
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Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months

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