Clinical Trial: Evaluating the Infectivity, Safety, and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-attenuated Respiratory Syncytial Virus Vaccine, LID ΔM2-2 1030s, Lot RSV#010A

Brief Summary:

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age.

This study is a companion study to IMPAACT 2011.


Detailed Summary:

Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age worldwide. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated RSV vaccine, RSV LID ΔM2-2 1030s, in RSV-seronegative infants 6 to 24 months of age.

Participants will be randomly assigned to receive a single dose of the RSV LID ΔM2-2 1030s vaccine or placebo (administered as nose drops) at study entry (Day 0).

Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season, and will remain on study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Total study duration is between 6 to 13 months, depending on when participants enroll in the study. Participants will attend several study visits throughout the study, and the visits may include blood collection, nasal washes, and physical examinations. Participants' parents or guardians will be contacted by study staff at various times during the study to monitor participants' health.


Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • Grades of study product-related solicited adverse events (AEs) as defined in the protocol [ Time Frame: Measured through Day 28 ]
  • Grades of study product-related unsolicited AEs [ Time Frame: Measured through Day 28 ]
  • Grades of study product-related serious adverse events (SAEs) [ Time Frame: Measured through Day 56 ]
  • Number of participants with infection with vaccine virus [ Time Frame: Measured through Day 56 ]
    Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) or 2) greater than or equal to 4-fold rise in RSV neutralizing antibody titer from Study Day 0-56
  • Peak titer of vaccine virus shed [ Time Frame: Measured through Day 28 ]
  • Duration of vaccine virus shedding in nasal washes measured by culture [ Time Frame: Measured through Day 28 ]
  • Duration of vaccine virus shedding in nasal washes measured by RT-PCR [ Time Frame: Measured through Day 28 ]
  • Greater than or equal to 4-fold rise in RSV-neutralizing antibody titer [ Time Frame: Measured through Day 56 ]
  • Antibody responses to RSV F glycoprotein as assessed by ELISA [ Time Frame: Measured through Day 56 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Frequency of symptomatic, medically attended respiratory and febrile illness in the vaccine and placebo recipients who experience natural infection with wt RSV during the subsequent RSV season [ Time Frame: Measured through 5 months ]
    Will be measured through the subsequent RSV season (November 1 in the calendar year of study entry to March 31 in the calendar year following study entry)
  • Measurement of antibody responses in the vaccine and placebo recipients who experience natural infection with wt RSV during the subsequent RSV season [ Time Frame: Measured at the participant's last study visit, up to a total of 6 to 13 months after study entry depending on when participants enroll in the study ]
    Will be measured at the post-RSV season visit (between April 1 and April 30 in the calendar year following study entry)
  • Changes from baseline in the B cell responses to RSV [ Time Frame: Measured through participant's last study visit, up to a total of 6 to 13 months after study entry depending on when participants enroll in the study ]
    Will be measured at the post-RSV season visit (between April 1 and April 30 in the calendar year following study entry)


Original Secondary Outcome: Same as current

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: October 31, 2016
Date Started: August 2016
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017