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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1b Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Seropositive Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444284
• Other study ID #: MV-005
• Status: Completed
• Phase: Phase 1
• Start date: June 9, 2020
• Est. completion date: May 7, 2021

Study information

• Verified date: June 2021
• Source: Meissa Vaccines, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Months to 59 Months

Eligibility

Key Inclusion Criteria:

1. Children aged 15-59 months

2. Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease

3. Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan

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), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)

2. Known or suspected immunodeficiency

3. Household or close contact with anyone = 6 months of age or with immunocompromised individual(s)

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 3 months prior to study inoculation, or planned 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 participant's safety and/or may interfere with study procedures or interpretation of results

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Biological:
• Investigational RSV vaccine MV-012-968 (Dosage 1)
Single dose administered intranasally on Day 1
• Investigational RSV vaccine MV-012-968 (Dosage 2)
Single dose administered intranasally on Day 1

Other:
• Placebo
Single dose administered intranasally on Day 1

Biological:
• Investigational RSV vaccine MV-012-968 (Dosage 3)
Single dose administered intranasally on Day 1

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Meridian Clinical Research	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Meissa Vaccines, Inc.

Country where clinical trial is conducted

United States, 

References & 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 enginee — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in serum RSV-specific neutralizing antibody titers	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	Change in serum binding (RSV F-specific) antibody titers	Change in serum binding (RSV F-specific) antibody titers will be measured per participant.	Baseline through Day 28, an average of six (6) weeks
Secondary	Change in nasal mucosal binding (RSV F-specific) antibody titers	Change in mucosal binding (RSV F-specific) antibody titers will be measured per participant.	Baseline through Day 28, an average of six (6) weeks
Secondary	Potential vaccine virus shedding: frequency	Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall.	Baseline through Day 28, an average of four (4) weeks
Secondary	Potential vaccine virus shedding: magnitude	If post-vaccination shedding of vaccine virus is detected by culture, peak viral titer (measured in plaque forming units, PFU) will be measured per dosage group and overall.	Baseline through Day 28, an average of four (4) weeks
Secondary	Potential vaccine virus shedding: duration	If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall.	Baseline through Day 28, an average of four (4) weeks