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Completed
NCT06546423
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
Conditions: Human Metapneumovirus, Human Parainfluenza Virus Type 3
Sex: All
Ages: 24 Months – 59 Months
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 24
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: CIR - Rangos, Johns Hopkins Bloomberg School of Public Health Baltimore Maryland
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 ≥ 24 months to \< 60 months of age. Children will receive B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-F-B365 vaccine, or placebo, and participants will not know which study product they have received.
The main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children.
The general procedures include daily temperature measurements and daily contact with the participant for the first 28 days, giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer, about 9 in-person visits, a physical examination, 7 clinical assessments, 2 blood samples, 9 nasal swabs and monthly contacts with the participant between Days 29-180.
Additional visits may occur if the child has a respiratory illness, fever, or ear infections. The illness visit will include a nasal swab and a clinical assessment.
Eligibility Criteria
Inclusion Criteria:
* ≥24 months of age and \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 Criteria:
* \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 \
Source: ClinicalTrials.gov (NCT06546423). StuddyBuddy aggregates publicly available trial information.