25 Participants Needed

Vaccines for Respiratory Infections in Children

Recruiting at 3 trial locations
SW
Overseen BySuzanne Woods, CCRP, CRNP-P
Age: < 18
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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?

The B/HPIV3/HMPV-F-B365 vaccine is unique because it targets specific respiratory viruses, potentially offering a more tailored approach compared to general vaccines for respiratory infections, which often focus on broader protection against multiple pathogens.12345

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

RK

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

HAI Screening for HPIV3-neutralizing antibody is obtained within the calendar year of inoculation
I am up to date with all vaccinations recommended for my age.
Seropositive for HPIV3 antibody, defined as serum HPIV3 HAI titer >1:8
See 6 more

Exclusion Criteria

I am receiving treatment for a heart condition.
I have had wheezing or used a bronchodilator since turning 1 year old.
I have not received human immunoglobulin or monoclonal antibodies in the last 6 months, except for RSV prevention.
See 24 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4 weeks
Daily contact, 9 in-person visits

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

22 weeks
Monthly contacts, 1 in-person visit on Day 180

Treatment Details

Interventions

  • B/HPIV3/HMPV-F-B365 vaccine
  • B/HPIV3/HMPV-PreF-A vaccine
Trial Overview The trial tests two experimental nasal spray vaccines against respiratory viruses in young children. It aims to assess safety and how well these vaccines work, involving daily check-ins, physical exams, blood samples, and nasal swabs over six months.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: B/HPIV3/HMPV-F-B365 vaccineActive Control1 Intervention
A single dose of intranasal B/HPIV3/HMPV-F-B365 will be administered by a Vax300 VaxINator atomization device.
Group II: B/HPIV3/HMPV-PreF-A vaccineActive Control1 Intervention
A single dose of intranasal B/HPIV3/HMPV-PreF-A will be administered by a Vax300 VaxINator atomization device.
Group III: PlaceboPlacebo Group1 Intervention
A single dose of intranasal Lactated Ringer's Solution for Injection will be administered by a Vax300 VaxINator atomization device.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Johns Hopkins Bloomberg School of Public Health

Collaborator

Trials
441
Recruited
2,157,000+

Vanderbilt University Medical Center

Collaborator

Trials
922
Recruited
939,000+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+

Findings from Research

The updated immunization schedule now includes the acellular pertussis vaccine and hepatitis B vaccine for all infants, ensuring early protection against these diseases.
Children with specific health conditions, such as asthma, diabetes, or heart disease, are recommended to receive the influenza vaccine, highlighting the importance of targeted immunization for at-risk populations.
Childhood immunization guidelines: current and future.Zimmerman, RK., Burns, IT.[2012]
The investigational hexavalent vaccine formulations were generally well tolerated in 60 healthy toddlers, with similar rates of injection-site reactions and fever compared to the licensed pentavalent vaccine.
Both new formulations of the hexavalent vaccine elicited comparable immune responses, although the PRP-T/HBV10 formulation showed higher anti-PRP antibody levels than the licensed vaccine, indicating potential for improved immunogenicity.
Safety and immunogenicity of two formulations of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae conjugate-hepatitis B vaccine in 15 to 18-month-old children.Halperin, SA., Langley, JM., Hesley, TM., et al.[2019]
In a study of 64 healthy infants aged 2-3 months, those who received the PRP + P vaccine showed a significant immune response, with 70% achieving protective antibody levels against H. influenzae type b, compared to less than 10% for the PRP vaccine alone.
The DPT vaccine was associated with more frequent local and systemic reactions than the PRP vaccine, indicating that while DPT may be effective, it may also lead to more side effects in infants.
Safety and immunogenicity of a new Haemophilus influenzae type b vaccine in infants under one year of age.King, SD., Ramlal, A., Wynter, H., et al.[2019]

References

Childhood immunization guidelines: current and future. [2012]
Safety and immunogenicity of two formulations of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae conjugate-hepatitis B vaccine in 15 to 18-month-old children. [2019]
Safety and immunogenicity of a new Haemophilus influenzae type b vaccine in infants under one year of age. [2019]
Disease caused by Haemophilus influenzae type b in the immediate period after homologous immunization: immunologic investigation. [2012]
Opsonophagocidal activity in sera from infants and children immunized with Haemophilus influenzae type b conjugate vaccine (meningococcal protein conjugate). [2007]
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