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

NCT04909021 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: MV-006
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 12

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.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

live attenuated vaccine; safety; immunogenicity; Phase 1 clinical trial; Pediatric; seronegative; children

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  Full study duration, an average of 1 year

• 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.

  Full study duration, an average of 1 year

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

  Change in serum RSV-specific neutralizing antibody (nAb) titers will be measured per participant.

  Baseline through Day 28, an average of six (6) weeks

Secondary Outcomes (5)

• Change in serum binding (RSV F-specific) Immunoglobulin G (IgG) concentrations

  Baseline through Day 28, an average of six (6) weeks

• Change in nasal mucosal binding (RSV F-specific) Immunoglobulin A (IgA) concentrations

  Baseline through Day 28, an average of six (6) weeks

• Potential vaccine virus shedding after a single intranasal dose of MV-012-968: frequency

  Intranasal inoculation through Day 22, an average of three (3) weeks

• Potential vaccine virus shedding after a single intranasal dose of MV-012-968: magnitude

  Intranasal inoculation through Day 22, an average of three (3) weeks

• Potential vaccine virus shedding after a single intranasal dose of MV-012-968: duration

  Intranasal inoculation through Day 22, an average of three (3) weeks

Other Outcomes (2)

• RSV-confirmed medically attended acute respiratory infection during peak RSV season following study inoculation

  Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology

• RSV-confirmed medically attended acute lower respiratory infection

  Approximately five (5) months duration during peak RSV season, adjusted for local epidemiology

Study Arms (6)

Dosage Group 1: RSV Vaccine Dosage 1

EXPERIMENTAL

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

Biological: Investigational RSV vaccine MV-012-968 (Dosage 1)

Dosage Group 2: RSV Vaccine Dosage 2

EXPERIMENTAL

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

Biological: Investigational RSV vaccine MV-012-968 (Dosage 2)

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

EXPERIMENTAL

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

Biological: Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)

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

EXPERIMENTAL

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

Biological: Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)

Placebo (Single-dose)

PLACEBO COMPARATOR

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

Other: Placebo (single-dose)

Placebo (Two-dose)

PLACEBO COMPARATOR

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

Other: Placebo (two-dose)

Interventions

Investigational RSV vaccine MV-012-968 (Dosage 1) BIOLOGICAL

Single dose administered intranasally on Day 1

Dosage Group 1: RSV Vaccine Dosage 1

Investigational RSV vaccine MV-012-968 (Dosage 2) BIOLOGICAL

Single dose administered intranasally on Day 1

Dosage Group 2: RSV Vaccine Dosage 2

Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose) BIOLOGICAL

Single dose administered intranasally on Day 1

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

Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose) BIOLOGICAL

Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit

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

Placebo (single-dose) OTHER

Single dose administered intranasally on Day 1

Placebo (Single-dose)

Placebo (two-dose) OTHER

Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit

Placebo (Two-dose)

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Meissa Vaccines, Inc.: lead

Study Sites (12)

MedPharmics

Phoenix, Arizona, 85015, United States

RECRUITING

Paradigm Clinical Research

La Mesa, California, 91942, United States

NOT YET RECRUITING

The Emory Children's Center

Atlanta, Georgia, 30322, United States

RECRUITING

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

NOT YET RECRUITING

MedPharmics

Metairie, Louisiana, 70006, United States

RECRUITING

Meridian Clinical Research

Hastings, Nebraska, 68901, United States

NOT YET RECRUITING

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

RECRUITING

Meridian Clinical Research

Binghamton, New York, 41348, United States

RECRUITING

Aventiv Research

Columbus, Ohio, 43213, United States

NOT YET RECRUITING

Coastal Pediatric Research

Summerville, South Carolina, 29486, United States

NOT YET RECRUITING

PanAmerican Clinical Research

Brownsville, Texas, 78520, United States

NOT YET RECRUITING

Benchmark Research

San Antonio, Texas, 78240, United States

RECRUITING

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

Study Officials

• Jay Lieberman, MD

  Meissa Vaccines, Inc.

  STUDY DIRECTOR

Central Study Contacts

Jay Lieberman, MD

CONTACT

3107538943; jay.lieberman@meissavaccines.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: June 3, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 2, 2022

Record last verified: 2022-08

Locations

US (12)