Safety and Immunogenicity of the RSV D46cpΔM2-2 Vaccine in RSV-Seropositive Children and RSV-Seronegative Infants and Children

NCT02601612 | Completed Phase 1 DMC

• 1 other identifier: CIR 308
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of the RSV D46cpΔM2-2 vaccine in RSV-seropositive children and RSV-seronegative infants and children.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (5)

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

  Measured at days 0-10 for seropositive and days 0-28 for seronegative

• Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study

  Measured at days 0-10 for seropositive and days 0-28 for seronegative

• Frequency of vaccine-related lower respiratory illness

  Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects

• Proportion of subjects shedding vaccine virus

  Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects

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

  Measured during study days 0-28 for seropositive subjects and study days 0-56 for seronegative subjects

Study Arms (4)

Group 1: D46cpΔM2-2 Vaccine

EXPERIMENTAL

RSV-seropositive children will receive a single dose of 10\^6 PFU D46cpΔM2-2 vaccine at study entry (day 0).

Biological: D46cpΔM2-2 vaccine

Group 1: Placebo

PLACEBO COMPARATOR

RSV-seropositive children will receive a single dose of placebo at study entry (day 0).

Biological: Placebo

Group 2: D46cpΔM2-2 Vaccine

EXPERIMENTAL

RSV-seronegative infants and children will receive a single dose of 10\^5 PFU D46cpΔM2-2 vaccine at study entry (day 0).

Biological: D46cpΔM2-2 vaccine

Group 2: Placebo

PLACEBO COMPARATOR

RSV-seronegative infants and children will receive a single dose of placebo at study entry (day 0).

Biological: Placebo

Interventions

D46cpΔM2-2 vaccine BIOLOGICAL

Delivered as nose drops

Group 1: D46cpΔM2-2 Vaccine; Group 2: D46cpΔM2-2 Vaccine

Placebo BIOLOGICAL

Delivered as nose drops

Group 1: Placebo; Group 2: Placebo

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Greater than or equal to 12 months of age and less than 60 months of age
• Received routine immunizations appropriate for age
• Serum RSV neutralizing antibody titer greater than or equal to 1:40
• Serum RSV neutralizing antibody result obtained this calendar year
• Pre-inoculation serum RSV neutralizing antibody specimen obtained less than or equal to 56 days prior to inoculation
• Parent/guardian has completed the study comprehension assessment
• Parent/guardian has signed the study informed consent document (ICD)
• Subject is expected to be available for the duration of the study

You may not qualify if:

• Evidence of chronic disease
• Within the past 6 months had a decline in height or weight growth that crosses two major growth percentiles (e.g., from above the 75th to below the 25th)
• Known or suspected impairment of immune function
• Maternal history of positive HIV test
• Bone marrow/solid organ transplant recipient
• Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
• Current or unresolved 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
• Wheezing episode or received bronchodilator therapy within the past 12 months
• Previous immunization with an experimental RSV vaccine
• Previous receipt or planned administration of anti-RSV antibody product
• Previous serious vaccine-associated AE or anaphylactic reaction
• Known hypersensitivity to any vaccine component

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

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

  Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)

  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: November 9, 2015
• First Posted: November 10, 2015
• Study Start: October 1, 2015
• Primary Completion: April 26, 2018
• Study Completion: April 26, 2018
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)