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Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-attenuated Respiratory Syncytial Virus Vaccine, RSV 6120/∆NS1, Lot RSV#018A, or RSV 6120/F1/G2/∆NS1, Lot RSV#016A, Delivered as Nose Drops to RSV-seropositive Children 12 to 59 Months of Age and RSV-seronegative Infants and Children 6 to 24 Months of Age

NCT03596801•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.

Detailed Description

This study will evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age. The vaccines will be evaluated in a stepwise fashion beginning with RSV-seropositive children (Group 1) and proceeding sequentially in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of RSV 6120/∆NS1, RSV 6120/F1/G2/∆NS1, or placebo at Day 0. Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 participants will be followed for 28 days after inoculation, and Group 2 participants will remain on the study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. The expected duration of the initial study is 28 days for Group 1 participants and between 6 and 13 months for Group 2 participants, depending upon time of enrollment. Study visits for all participants may include clinical assessments, blood collection, and nasal washes or nasal swabs. Additionally, participants' parents or guardians will be contacted by study staff at various times during the study to monitor participants' health.

Eligibility

Age

0 - 4 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Greater than or equal to 12 months of age and less than 60 months of age at the time of inoculation
•Screening serum specimen for RSV-neutralizing antibody is obtained within the calendar year of inoculation
•Seropositive for RSV antibody, defined as serum RSV-neutralizing antibody titer greater than or equal to 1:40
•Pre-inoculation serum sample for RSV-neutralizing antibody specimen is obtained no more than 56 days prior to inoculation
•In good health based on review of the medical record, history, and physical examination (PE) at the time of inoculation
•Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger
•Growing normally for age as demonstrated on a standard growth chart and has a current height and weight above the 3rd percentile for age
•Expected to be available for the duration of the study
•Parent/guardian is willing and able to provide written informed consent
•Greater than or equal to 6 months of age and less than 25 months of age at the time of inoculation
+9 more criteria

Exclusion Criteria

•Born at less than 34 weeks gestation
•Maternal history of positive human immunodeficiency virus (HIV) test
•Evidence of chronic disease
•Known or suspected impairment of immune function
•Bone marrow/solid organ transplant recipient
•Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
•Suspected or documented developmental disorder, delay, or other developmental problem
•Cardiac abnormality requiring treatment
•Lung disease or reactive airway disease
•More than one episode of wheezing in the first year of life
+84 more criteria

Locations (1)

Johns Hopkins University Center for Immunization Research

Baltimore, Maryland, United States

Key Dates

Start Date

June 29, 2018

Primary Completion Date

April 25, 2024

Completion Date

April 25, 2024

Last Updated

February 13, 2026

Enrollment

ACTUAL participants

Conditions

RSV Infection

Interventions

RSV 6120/∆NS1

BIOLOGICAL

RSV 6120/F1/G2/∆NS1

BIOLOGICAL

Placebo

BIOLOGICAL

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

NCT06583031

RSV InfectionhMPV

View study

COMPLETEDPHASE1

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

NCT04520659

RSV Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Inclusion Criteria

Exclusion Criteria

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

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