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

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Conditions

Human MetapneumovirusHuman Parainfluenza Virus Type 3

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase I Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, Bovine/Human, Parainfluenza Virus Type 3 (B/HPIV3) Vectored Vaccines Expressing the Fusion Glycoprotein of Human Metapneumovirus (HMPV), Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age

Quick Facts

Study Start:2024-07-12
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06546423

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Months to 59 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * ≥24 months of age and \<60 months of age at the time of inoculation
  2. * HAI Screening for HPIV3-neutralizing antibody is obtained within the calendar year of inoculation
  3. * Seropositive for HPIV3 antibody, defined as serum HPIV3 HAI titer \>1:8
  4. * Pre-inoculation serum sample for HPIV3-neutralizing antibody specimen is obtained no more than 42 days prior to inoculation
  5. * In good health based on review of the medical record, history, and physical examination at the time of inoculation
  6. * 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
  7. * 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
  8. * Expected to be available for the duration of the study
  9. * Parent/guardian is willing and able to provide written informed consent
  1. * \<24 months of age and \>60 months of age at the time of inoculation.
  2. * Born at less than 34 weeks gestation
  3. * Maternal history of a positive HIV test before or during pregnancy.
  4. * Evidence of chronic disease
  5. * Known or suspected infection or impairment of immunological functions
  6. * Bone marrow/solid organ transplant recipient
  7. * Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
  8. * Suspected or documented developmental disorder, delay, or other developmental problem
  9. * Cardiac abnormality requiring treatment
  10. * Lung disease or reactive airway disease
  11. * More than one episode of medically diagnosed wheezing in the first year of life
  12. * Wheezing episode or received bronchodilator therapy or racemic epinephrine within the past 12 months
  13. * Wheezing episode or received bronchodilator therapy after the age of 12 months
  14. * Previous receipt of supplemental oxygen therapy in a home setting
  15. * Previous receipt of an investigational HPIV3 or HMPV vaccine
  16. * 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
  17. * Previous receipt of any blood products within the past 6 months.
  18. * Previous anaphylactic reaction
  19. * Previous vaccine-associated adverse reaction that was Grade 3 or above.
  20. * Known hypersensitivity to any study product component
  21. * 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
  22. * 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:
  23. * a person who is HIV-infected
  24. * a person who has cancer and has received chemotherapy within the 12 months prior to enrollment
  25. * a person living with a solid organ or bone marrow transplant
  26. * 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
  27. * Receipt of any of the following prior to enrollment:
  28. * inactivated influenza vaccine within 3 days prior, or
  29. * any other inactivated vaccine, messenger RNA (mRNA) vaccine, or live-attenuated rotavirus vaccine within the 14 days prior, or
  30. * any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
  31. * another investigational vaccine or investigational drug within 28 days prior, or
  32. * salicylate (aspirin) or salicylate-containing products within the past 28 days
  33. * Scheduled administration of any of the following after planned inoculation:
  34. * inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
  35. * any live vaccine other than rotavirus within the 28 days after, or
  36. * any salicylate or salicylate-containing products within the 28 days after, or
  37. * another investigational vaccine or investigational drug in the 56 days after
  38. * Receipt of any of the following medications within 3 days prior to study enrollment:
  39. * systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
  40. * intranasal medications, or
  41. * other prescription medications except the permitted concomitant medications listed below
  42. * 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
  43. * Any of the following events at the time of enrollment:
  44. * fever (temporal or rectal temperature of ≥100.4°F), or
  45. * upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis), or
  46. * nasal congestion significant enough to interfere with successful inoculation, or
  47. * otitis media, or
  48. * contact with a person diagnosed with COVID-19 disease or active SARS-CoV-2 infection within the preceding 10 days

Contacts and Locations

Study Contact

Suzanne Woods, CCRP, CRNP-P
CONTACT
(443) 813-0697
swoods12@jhu.edu

Principal Investigator

Ruth Karron, M.D.
PRINCIPAL_INVESTIGATOR
Center for Immunization Research, JHBSPH

Study Locations (Sites)

CIR - Rangos, Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
United States
CIR South
Columbia, Maryland, 21045
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Ruth Karron, M.D., PRINCIPAL_INVESTIGATOR, Center for Immunization Research, JHBSPH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-12
Study Completion Date2025-06

Study Record Updates

Study Start Date2024-07-12
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Human Metapneumovirus
  • Human Parainfluenza Virus Type 3