Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

NCT01968083 | Completed Phase 1 DMC

• 2 other identifiers: P111411948
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

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.

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)

  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 Vaccine BIOLOGICAL

10\^5.3 plaque forming units (PFUs) or 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 Vaccine BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents/guardians who demonstrate their understanding of the study (by taking a multiple choice questionnaire), 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/immunization
• 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
• For children born to HIV-infected women: two negative polymerase chain reaction (PCR) tests with one collected when greater than 1 month of age and one collected when greater than 4 months old, and no positive HIV PCR test; or two negative HIV antibody tests

You may not qualify if:

• Known or suspected impairment of immunological functions or HIV infection
• 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 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 infant less than 6 months of age
• Member of a household that contains an immunocompromised individual (including, but not limited to: those with HIV-related immunodeficiency, defined as CD4 less than 300, or less than 15% if less than 5 years of age, measured within the previous 6 months; or any household members who have received chemotherapy within the last 12 months). Verbal report is sufficient documentation if the parent/guardian is confident of history.
• 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 significant enough to interfere with successful vaccination, or otitis media
• Participant 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
• Participant 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

University of California, UC San Diego CRS

La Jolla, California, 92093-0672, United States

Location

Miller Children's Hospital at Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

The Children's Hospital University of Colorado

Denver, Colorado, 80045, United States

Location

Rush Univ. Cook County Hosp. Chicago NICHD CRS

Chicago, Illinois, 60612, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614-3393, 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: 29509929 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Coleen K. Cunningham, MD

  Chief, Pediatric Infectious Diseases; T915, Children's Health Center

  STUDY CHAIR

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: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 3, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 26, 2021

Record last verified: 2017-01

Locations

US (5)