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RECRUITING
NCT06546423
PHASE1

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

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

24 Months - 59 Months

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-07-12

Completion Date

2025-06

Last Updated

2024-08-12

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

B/HPIV3/HMPV-PreF-A vaccine

B/HPIV3/HMPV-PreF-A is a live-attenuated vaccine candidate. The B/HPIV3/HMPV-PreF-A vaccine is provided in a sterile 2.0-mL cryovial, each containing 0.6 mL of vaccine with a titer of approximately 10\^6.7 PFU/mL. The vaccine virus concentrate is diluted with Lactated Ringer's Solution for Injection to a dose of approximately 10\^5.6 PFU in a 0.2 mL volume.

BIOLOGICAL

B/HPIV3/HMPV-F-B365 vaccine

B/HPIV3/HMPV-F-B365 is a live-attenuated vaccine candidate. The B/HPIV3/HMPV-F-B365 vaccine is provided in a sterile 2.0-mL cryovial, each containing 0.6 mL of vaccine with a titer of approximately 10\^6.3 PFU/mL. The vaccine virus concentrate is diluted with Lactated Ringer's Solution for Injection to a dose of approximately 10\^5.6 PFU in a 0.2 mL volume.

DRUG

Placebo

Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. It will be drawn up in a sterile syringe to a volume of 0.2 mL.

Locations (4)

CIR - Rangos, Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

CIR South

Columbia, Maryland, United States

University of Rochester Medical Center

Rochester, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States