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

PHASE1RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

July 12, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Human MetapneumovirusHuman Parainfluenza Virus Type 3
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.

Trial Locations (4)

14642

RECRUITING

University of Rochester Medical Center, Rochester

21045

RECRUITING

CIR South, Columbia

21205

RECRUITING

CIR - Rangos, Johns Hopkins Bloomberg School of Public Health, Baltimore

37232

NOT_YET_RECRUITING

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

collaborator

Vanderbilt University Medical Center

OTHER

collaborator

University of Rochester

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH