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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
33
10\^5.0 PFU; administered as nose drops
Administered as nose drops
Center for Immunization Research
Baltimore, Maryland, United States
Center for Immunization Research South
Laurel, Maryland, United States
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
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
Time frame: Measured through Day 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
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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
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)
Time frame: Measured through 5 months
Measurement of antibody responses in the vaccine and placebo recipients who experience natural infection with wt RSV during the subsequent RSV season
Will be measured at the post-RSV season visit (between April 1 and April 30 in the calendar year following study entry)
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
Changes from baseline in the B cell responses to RSV
Will be measured at the post-RSV season visit (between April 1 and April 30 in the calendar year following study entry)
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