NCT01852266

Brief Summary

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

May 8, 2013

Last Update Submit

September 13, 2016

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (2)

  • Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study (Days 0-28)

    Measured through Day 28

  • Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination

    Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA).

    Measured through study follow-up period, up to 1 year after study entry

Study Arms (2)

RSV cps2 Vaccine

EXPERIMENTAL

Participants will receive one dose of the RSV cps2 vaccine administered as nose drops at study entry.

Biological: RSV cps2 Vaccine

Placebo

PLACEBO COMPARATOR

Participants will receive one dose of placebo administered as nose drops at study entry.

Biological: Placebo Vaccine

Interventions

RSV cps2 VaccineBIOLOGICAL

10\^5.3 plaque forming units (PFUs) of RSV cps2 vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).

RSV cps2 Vaccine
Placebo VaccineBIOLOGICAL

Placebo vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).

Placebo

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • At least 6 months to less than 25 months of age at the time of enrollment
  • Parents/guardians who demonstrate their understanding of the study (by taking the comprehension assessment), sign the informed consent, and agree to vaccine administration following detailed explanation of the study
  • Seronegative for RSV antibody, defined as a serum RSV neutralizing antibody titer less than 1:40 as determined within 42 days prior to enrollment
  • Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health
  • In the view of the site investigator, the participant has received routine immunizations appropriate for their age
  • Participant is expected to be available for the duration of the study

You may not qualify if:

  • Known or suspected impairment of immunological functions, including maternal history of positive HIV test
  • Receipt of immunosuppressive therapy including systemic corticosteroids within 30 days of study entry. NOTE: Topical steroids, topical antibiotic, and topical antifungal medications are acceptable within 24 hours of enrollment. May be reassessed after symptoms have resolved.
  • Bone marrow/solid organ transplant recipients
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product
  • Previous serious vaccine-associated AE or any anaphylactic reaction
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including any wheezing event or reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
  • Member of a household that includes an immunocompromised individual or infants less than 6 months of age
  • Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
  • Fever (rectal temperature of greater than or equal to 100.4°F \[38°C\]), or upper respiratory illness (rhinorrhea, cough, or pharyngitis) or nasal congestion (that is significant enough to interfere with successful vaccination), or otitis media
  • Has received any killed vaccine or live attenuated rotavirus vaccine within the last 2 weeks, any other live vaccine within the last 4 weeks, or gamma globulin (or other antibody products) within the past 3 months or is scheduled to receive any immunization in the 28 days after enrollment
  • Receipt of another investigational vaccine or investigational drug within 28 days of receiving this investigational RSV vaccine
  • Has received antibiotics or systemic or nasal steroid therapy or other prescription medications for acute illness within 3 days of study entry. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) topical steroids, topical antibiotics, and topical antifungal agents.
  • Has received salicylate (aspirin) or salicylate-containing products within the past month
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University, Center for Immunization Research (CIR)

Baltimore, Maryland, 21505, United States

Location

Johns Hopkins University, Center for Immunization Research South

Laurel, Maryland, 20708, United States

Location

Related Publications (1)

  • Buchholz UJ, Cunningham CK, Muresan P, Gnanashanmugam D, Sato P, Siberry GK, Rexroad V, Valentine M, Perlowski C, Schappell E, Thumar B, Luongo C, Barr E, Aziz M, Yogev R, Spector SA, Collins PL, McFarland EJ, Karron RA; International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1114 Study Team. Live Respiratory Syncytial Virus (RSV) Vaccine Candidate Containing Stabilized Temperature-Sensitivity Mutations Is Highly Attenuated in RSV-Seronegative Infants and Children. J Infect Dis. 2018 Apr 11;217(9):1338-1346. doi: 10.1093/infdis/jiy066.

    PMID: 29509929DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Ruth A. Karron, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 13, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

US(2)