Clinical trial NCT04444284: Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: Live attenuated vaccine
Safety
Immunogenicity
Phase 1 clinical trial
Pediatric
Seropositive
Lead sponsor: Meissa Vaccines, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-23
Enrollment: 34
Sex: ALL
Minimum age (years): 15
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Solicited adverse events (AEs)
timeFrame: Immediate post-vaccination period
measure: Unsolicited AEs
timeFrame: Immediate post-vaccination period
measure: Serious adverse events (SAEs)
timeFrame: Full study duration, an average of 6 months
measure: Medically attended adverse events (MAEs)
timeFrame: Full study duration, an average of 6 months
Secondary outcomes:
measure: Change in serum RSV-specific neutralizing antibody titers
timeFrame: Baseline through Day 28, an average of six (6) weeks
measure: Change in serum binding (RSV F-specific) antibody titers
timeFrame: Baseline through Day 28, an average of six (6) weeks
measure: Change in nasal mucosal binding (RSV F-specific) antibody titers
timeFrame: Baseline through Day 28, an average of six (6) weeks
measure: Potential vaccine virus shedding: frequency
timeFrame: Baseline through Day 28, an average of four (4) weeks
measure: Potential vaccine virus shedding: magnitude
timeFrame: Baseline through Day 28, an average of four (4) weeks
measure: Potential vaccine virus shedding: duration
timeFrame: Baseline through Day 28, an average of four (4) weeks
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Meissa Vaccines, Inc.
name: Oliver Medzihradsky, MD MPH MS
role: STUDY_DIRECTOR
References:
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.