Status:
RECRUITING
Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Vanderbilt University Medical Center
Conditions:
Human Metapneumovirus
Human Parainfluenza Virus Type 3
Eligibility:
All Genders
24-59 years
Phase:
PHASE1
Brief Summary
HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ...
Detailed Description
This is a blinded, randomized, placebo-controlled study design will be used to evaluate the safety and immunogenicity of the study product in HPIV3-seropositive participants. The study will be perform...
Eligibility Criteria
Inclusion
- ≥24 months of age and \<60 months of age at the time of inoculation
- HAI Screening for HPIV3-neutralizing antibody is obtained within the calendar year of inoculation
- Seropositive for HPIV3 antibody, defined as serum HPIV3 HAI titer \>1:8
- Pre-inoculation serum sample for HPIV3-neutralizing antibody specimen is obtained no more than 42 days prior to inoculation
- In good health based on review of the medical record, history, and physical examination at the time of inoculation
- Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger
- Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age
- Expected to be available for the duration of the study
- Parent/guardian is willing and able to provide written informed consent
Exclusion
- \<24 months of age and \>60 months of age at the time of inoculation.
- Born at less than 34 weeks gestation
- Maternal history of a positive HIV test before or during pregnancy.
- Evidence of chronic disease
- Known or suspected infection or impairment of immunological functions
- Bone marrow/solid organ transplant recipient
- Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
- Suspected or documented developmental disorder, delay, or other developmental problem
- Cardiac abnormality requiring treatment
- Lung disease or reactive airway disease
- More than one episode of medically diagnosed wheezing in the first year of life
- Wheezing episode or received bronchodilator therapy or racemic epinephrine within the past 12 months
- Wheezing episode or received bronchodilator therapy after the age of 12 months
- Previous receipt of supplemental oxygen therapy in a home setting
- Previous receipt of an investigational HPIV3 or HMPV vaccine
- Previous receipt or planned administration of human immunoglobulin within the past 6 months. Receipt of licensed monoclonal antibody products for passive prophylaxis against RSV (e.g., nirsevimab) within the past 6 months is not a cause for exclusion
- Previous receipt of any blood products within the past 6 months.
- Previous anaphylactic reaction
- Previous vaccine-associated adverse reaction that was Grade 3 or above.
- Known hypersensitivity to any study product component
- Member of a household that contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation
- Member of a household that, at the date of inoculation through the 10th day after inoculation, contains an immunocompromised individual including but not limited to:
- a person who is HIV-infected
- a person who has cancer and has received chemotherapy within the 12 months prior to enrollment
- a person living with a solid organ or bone marrow transplant
- Attends a daycare facility that does not separate children by age and contains a child \<12 months of age at the date of inoculation through the 10th day after inoculation
- Receipt of any of the following prior to enrollment:
- inactivated influenza vaccine within 3 days prior, or
- any other inactivated vaccine, messenger RNA (mRNA) vaccine, or live-attenuated rotavirus vaccine within the 14 days prior, or
- any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
- another investigational vaccine or investigational drug within 28 days prior, or
- salicylate (aspirin) or salicylate-containing products within the past 28 days
- Scheduled administration of any of the following after planned inoculation:
- inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
- any live vaccine other than rotavirus within the 28 days after, or
- any salicylate or salicylate-containing products within the 28 days after, or
- another investigational vaccine or investigational drug in the 56 days after
- Receipt of any of the following medications within 3 days prior to study enrollment:
- systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
- intranasal medications, or
- other prescription medications except the permitted concomitant medications listed below
- Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents
- Any of the following events at the time of enrollment:
- fever (temporal or rectal temperature of ≥100.4°F), or
- upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis), or
- nasal congestion significant enough to interfere with successful inoculation, or
- otitis media, or
- contact with a person diagnosed with COVID-19 disease or active SARS-CoV-2 infection within the preceding 10 days
Key Trial Info
Start Date :
July 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06546423
Start Date
July 12 2024
End Date
June 1 2025
Last Update
August 12 2024
Active Locations (4)
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1
CIR - Rangos, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
2
CIR South
Columbia, Maryland, United States, 21045
3
University of Rochester Medical Center
Rochester, New York, United States, 14642
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232