Vaccines for Respiratory Infections in Children
Trial Summary
Will I have to stop taking my current medications?
The trial requires stopping certain medications before and after enrollment. You must avoid certain vaccines, salicylate products, and specific medications like antibiotics and antivirals for a set period before and after the trial. However, some medications like nutritional supplements and topical treatments are allowed.
How is the B/HPIV3/HMPV-F-B365 vaccine treatment different from other treatments for respiratory infections in children?
What is the purpose of this trial?
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.
Research Team
Ruth Karron, M.D.
Principal Investigator
Center for Immunization Research, JHBSPH
Eligibility Criteria
This trial is for HPIV3-seropositive children aged 24 to less than 60 months who may have had breathing issues due to certain viruses. The study excludes those not meeting the age requirement or with conditions that could interfere with vaccine assessment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Acute Phase
Participants receive a single dose of the study vaccine or placebo and are monitored daily for 28 days for adverse events and vaccine virus shedding
Follow-up
Participants are monitored for Medically Attended Adverse Events (MAAEs) and Serious Adverse Events (SAEs) with monthly contacts and a final assessment on Day 180
Treatment Details
Interventions
- B/HPIV3/HMPV-F-B365 vaccine
- B/HPIV3/HMPV-PreF-A vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborator
Vanderbilt University Medical Center
Collaborator
University of Rochester
Collaborator