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

NCT01893554 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CIR 288
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV

Outcome Measures

Primary Outcomes (2)

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

  Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children

• 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 follow-up period, up to 1 year after study entry

Study Arms (8)

Group 1: RSV vaccine

EXPERIMENTAL

Healthy RSV-seropositive children ages 12 to 59 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Biological: RSV ΔNS2 Δ1313 I1314L Vaccine

Group 1: Placebo

PLACEBO COMPARATOR

Healthy RSV-seropositive children ages 12 to 59 months will receive one dose of the placebo administered as nose drops at study entry.

Biological: Placebo

Group 2: RSV vaccine

EXPERIMENTAL

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Biological: RSV ΔNS2 Δ1313 I1314L Vaccine

Group 2: Placebo

PLACEBO COMPARATOR

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry.

Biological: Placebo

Group 3: RSV vaccine

EXPERIMENTAL

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Biological: RSV ΔNS2 Δ1313 I1314L Vaccine

Group 3: Placebo

PLACEBO COMPARATOR

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry.

Biological: Placebo

Group 4: RSV vaccine

EXPERIMENTAL

Healthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Biological: RSV ΔNS2 Δ1313 I1314L Vaccine

Group 4: Placebo

PLACEBO COMPARATOR

Healthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the placebo administered as nose drops at study entry.

Biological: Placebo

Interventions

RSV ΔNS2 Δ1313 I1314L Vaccine BIOLOGICAL

For participants in Groups 1, 3, and 4: 10\^6 plaque forming units (PFU) of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL). For participants in Group 2: 10\^5 PFU of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL).

Group 1: RSV vaccine; Group 2: RSV vaccine; Group 3: RSV vaccine; Group 4: RSV vaccine

Placebo BIOLOGICAL

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

Group 1: Placebo; Group 2: Placebo; Group 3: Placebo; Group 4: Placebo

Eligibility Criteria

• Age: 4 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children at least 12 but less than 60 months of age, whose parent/guardian understands and signs the study informed consent and who agrees to vaccine administration following a detailed explanation of the study
• Seropositive for RSV as defined by serum RSV neutralizing antibody titer equal to or greater than 1:40. If a child at least 12 but less than 60 months of age is determined to be RSV seropositive prior to Day 56, s/he does not need an additional screening serum specimen, but a pre-inoculation serum specimen must be obtained.
• Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health
• 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, receiving immunosuppressive therapy including systemic corticosteroids, or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
• 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 immunocompromised individual or infants less than 6 months of age, other than a study participant
• 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. Note: children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
• Healthy children at least 6 but less than 25 months of age whose parents/guardians can understand and sign the informed consent and who 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 not more than 42 days prior to inoculation
• Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.
• Participant is expected to be available for the duration of the study
• Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids, or 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (2)

Center for Immunization Research (CIR)

Baltimore, Maryland, 21205, United States

Location

Center for Immunization Research South

Laurel, Maryland, 20708, United States

Location

Related Publications (1)

• Karron RA, Luongo C, Mateo JS, Wanionek K, Collins PL, Buchholz UJ. Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/DeltaNS2/Delta1313/I1314L in RSV-Seronegative Children. J Infect Dis. 2020 Jun 16;222(1):82-91. doi: 10.1093/infdis/jiz408.

  PMID: 31605113 BACKGROUND

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

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

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: July 2, 2013
• First Posted: July 9, 2013
• Study Start: June 1, 2013
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: May 13, 2026

Record last verified: 2025-07

Locations

US (2)