Vaccines for Respiratory Infections in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of two new vaccines for respiratory infections in children. These vaccines, named B/HPIV3/HMPV-F-B365 and B/HPIV3/HMPV-PreF-A, target viruses that can cause breathing issues, especially in children who have previously had such infections. Participants will receive either one of the vaccines or a placebo (a harmless substitute) without knowing which they received. Children with past respiratory infections and antibodies for these viruses might be suitable candidates. The study routine includes daily temperature checks, regular check-ins, and a few clinic visits. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive these new vaccines.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that the B/HPIV3/HMPV-F-B365 vaccine targets specific respiratory viruses, potentially helping to protect against infections. The B/HPIV3/HMPV-PreF-A vaccine also did not raise major safety concerns in children who received it. For both vaccines, researchers reported no serious side effects in the children studied, indicating they were generally well-tolerated.
As these are Phase 1 studies, the primary goal is to assess the safety of these vaccines. Scientists continue to collect information, but so far, the vaccines appear safe for young children.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these vaccines for respiratory infections in children because they introduce a novel approach to prevention. Unlike traditional vaccines that may require injections, both the B/HPIV3/HMPV-F-B365 and B/HPIV3/HMPV-PreF-A vaccines are administered intranasally with the Vax300 VaxINator atomization device, making them potentially more comfortable and easier to administer, especially for kids. Additionally, these vaccines target multiple respiratory viruses at once, which could offer broader protection compared to current vaccines that typically focus on a single virus. This innovative delivery method and the multi-targeted approach hold promise for enhancing the effectiveness and convenience of respiratory infection prevention in children.
What evidence suggests that this trial's vaccines could be effective for respiratory infections in children?
This trial will compare the B/HPIV3/HMPV-F-B365 vaccine and the B/HPIV3/HMPV-PreF-A vaccine, both designed to combat specific viruses that cause breathing problems in children. Participants will receive one of these vaccines or a placebo. Research has shown that these vaccines boost the immune system to better defend against HPIV3 and HMPV, which often lead to respiratory infections. Earlier studies with similar vaccines demonstrated that they can help protect against these infections by enhancing the body's natural defenses. Early results suggest these vaccines might provide more specific protection than general treatments. Although the data remains in the early stages, the vaccines have shown promise in preventing these viral infections in young children.12367
Who Is on the Research Team?
Ruth Karron, M.D.
Principal Investigator
Center for Immunization Research, JHBSPH
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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