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Completed

NCT Number: NCT04444284

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

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.

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

15 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Meridian Clinical Research, Norfolk, Nebraska, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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)

Key Exclusion Criteria:

  • 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

Treatment and study plan

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

Biological

Single dose administered intranasally on Day 1

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

Biological

Single dose administered intranasally on Day 1

Placebo

Other

Single dose administered intranasally on Day 1

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

Biological

Single dose administered intranasally on Day 1

Primary outcomes

  1. Solicited adverse events (AEs)

    Time frame: Immediate post-vaccination period

    Frequency of solicited AEs will be measured, categorized by severity. Solicited AEs are predefined AEs that may occur after investigational vaccine administration

  2. Unsolicited AEs

    Time frame: Immediate post-vaccination period

    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.

  3. Serious adverse events (SAEs)

    Time frame: Full study duration, an average of 6 months

    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.

  4. Medically attended adverse events (MAEs)

    Time frame: Full study duration, an average of 6 months

    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.

Secondary outcomes

  1. Change in serum RSV-specific neutralizing antibody titers

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

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

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

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

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

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

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

    Change in mucosal binding (RSV F-specific) antibody titers will be measured per participant.

  4. Potential vaccine virus shedding: frequency

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

    Frequency of any post-vaccination shedding of vaccine virus (as detected by viral culture) will be measured per dosage group and overall.

  5. Potential vaccine virus shedding: magnitude

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

    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.

  6. Potential vaccine virus shedding: duration

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

    If post-vaccination shedding of vaccine virus is detected by culture, duration of shedding (in days) will be measured per dosage group and overall.

Sponsors and collaborators

Lead sponsor

Meissa Vaccines, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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