Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children

NCT04444284 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MV-005
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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 drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Live attenuated vaccine; Safety; Immunogenicity; Phase 1 clinical trial; Pediatric; Seropositive

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 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 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.

  Full study duration, an average of 6 months

Secondary Outcomes (6)

• Change in serum RSV-specific neutralizing antibody titers

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

• Change in serum binding (RSV F-specific) antibody titers

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

• Change in nasal mucosal binding (RSV F-specific) antibody titers

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

• Potential vaccine virus shedding: frequency

  Baseline through Day 28, an average of four (4) weeks

• Potential vaccine virus shedding: magnitude

  Baseline through Day 28, an average of four (4) weeks

Study Arms (5)

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 1: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

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 2: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Dosage Group 3: RSV Vaccine Dosage 3

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)

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

Placebo OTHER

Single dose administered intranasally on Day 1

Dosage Group 1: Placebo; Dosage Group 2: Placebo

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

Single dose administered intranasally on Day 1

Dosage Group 3: RSV Vaccine Dosage 3

Eligibility Criteria

• Age: 15 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 15-59 months
• Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
• Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
• 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), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
• Known or suspected immunodeficiency
• Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
• 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 3 months prior to study inoculation, or planned 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 participant's safety and/or may interfere with study procedures or interpretation of results

Sponsors & Collaborators

• Meissa Vaccines, Inc.: lead

Study Sites (3)

Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, 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 RESULT

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: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study is single-mask in 2 of the 3 dosage groups: study participants and their parent(s)/guardian(s) will not know their child's study assignment, whereas investigators, site staff, and site pharmacists will remain unmasked.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The first 15 enrolled participants will be assigned to Dosage Group 1 and be randomly allocated to receive either investigational vaccine at Dosage 1 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 1 safety data through Day 14, to allow dosage escalation. The next 15 enrolled participants will be assigned to Dosage Group 2 and be randomly allocated to receive investigational vaccine at Dosage 2 or placebo. The Safety Monitoring Committee will subsequently review Dosage Group 2 safety data through Day 14, to allow dosage escalation. The final group (Dosage Group 3) will consist of up to 12 enrolled participants who will be allocated to receive investigational vaccine at Dosage 3.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 23, 2020
• Study Start: June 9, 2020
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

US (3)