Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children
- Conditions
- RSV Infection
- Interventions
- Registration Number
- NCT03596801
- Brief Summary
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.
- Detailed Description
This study will evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.
The vaccines will be evaluated in a stepwise fashion beginning with RSV-seropositive children (Group 1) and proceeding sequentially in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of RSV 6120/∆NS1, RSV 6120/F1/G2/∆NS1, or placebo at Day 0.
Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 participants will be followed for 28 days after inoculation, and Group 2 participants will remain on the study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. The expected duration of the initial study is 28 days for Group 1 participants and between 6 and 13 months for Group 2 participants, depending upon time of enrollment.
Study visits for all participants may include clinical assessments, blood collection, and nasal washes. Additionally, participants' parents or guardians will be contacted by study staff at various times during the study to monitor participants' health.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: RSV 6120/∆NS1 Vaccine RSV 6120/∆NS1 Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS1 vaccine at Day 0. Group 2: RSV 6120/F1/G2/∆NS1 RSV 6120/F1/G2/∆NS1 Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0. Group 2: Placebo Placebo Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of placebo at Day 0. Group 1: RSV 6120/∆NS1 Vaccine RSV 6120/∆NS1 Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0. Group 1: RSV 6120/F1/G2/∆NS1 Vaccine RSV 6120/F1/G2/∆NS1 Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0. Group 1: Placebo Placebo Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.
- Primary Outcome Measures
Name Time Method Grades of study product-related solicited adverse events (AEs) (RSV-seropositive participants) Measured through Day 10 Graded using the protocol-defined grading system
Duration of virus shedding in nasal washes (RSV-seronegative participants) Measured through Day 28 As determined by a) culture and b) rRT-PCR
Grades of study product-related solicited AEs (RSV-seronegative participants) Measured through Day 28 Graded using the protocol-defined grading system
Grades of study product-related serious adverse events (SAEs) (RSV-seropositive participants) Measured through Day 28 Graded using the protocol-defined grading system
Frequency of infection with RSV (RSV-seropositive participants) Measured through Day 28 Defined as 1) vaccine virus identified in nasal wash (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) or 2) a greater than or equal to 4-fold rise in serum RSV neutralizing antibody titer or serum RSV F (IgG) titer
Duration of virus shedding in nasal washes (RSV-seropositive participants) Measured through Day 10 As determined by a) culture and b) reverse transcription polymerase chain reaction (rRT-PCR)
Frequency of a greater than or equal to 4-fold rise in RSV-neutralizing antibody titer (RSV-seropositive participants) Measured through Day 28 Based on laboratory evaluations
Frequency of a greater than or equal to 4-fold rise in RSV-neutralizing antibody titer (RSV-seronegative participants) Measured through Day 56 Based on laboratory evaluations
Frequency of a greater than or equal to 4-fold rise in immunoglobulin G (IgG) antibody responses to RSV F glycoprotein (RSV-seropositive participants) Measured through Day 28 As determined by ELISA
Grades of study product-related unsolicited AEs (RSV-seropositive participants) Measured through Day 10 Graded using the protocol-defined grading system
Grades of study product-related unsolicited AEs (RSV-seronegative participants) Measured through Day 28 Graded using the protocol-defined grading system
Grades of study product-related SAEs (RSV-seronegative participants) Measured through Day 56 Graded using the protocol-defined grading system
Peak titer of vaccine virus shed (RSV-seropositive participants) Measured through Day 10 Based on laboratory evaluations
Peak titer of vaccine virus shed (RSV-seronegative participants) Measured through Day 28 Based on laboratory evaluations
Frequency of infection with RSV (RSV-seronegative participants) Measured through Day 56 Defined as 1) vaccine virus identified in nasal wash (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) or 2) a greater than or equal to 4-fold rise in serum RSV neutralizing antibody titer or serum RSV F (IgG) titer
Frequency of a greater than or equal to 4-fold rise in IgG antibody responses to RSV F glycoprotein (RSV-seronegative participants) Measured through Day 56 As determined by ELISA
- Secondary Outcome Measures
Name Time Method Frequency of symptomatic, medically attended respiratory and febrile illness in the RSV-seronegative (group 2) vaccine and placebo recipients who experience natural infection with wt RSV during the RSV season Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study Based on laboratory evaluations
Severity of symptomatic, medically attended respiratory and febrile illness in the RSV-seronegative (group 2) vaccine and placebo recipients who experience natural infection with wt RSV during the RSV season Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study Based on laboratory evaluations
Frequency of antibody responses in the RSV-seronegative vaccine and placebo recipients who experience natural infection with wt RSV during the RSV season Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study Based on laboratory evaluations
Measurement of mucosal antibody titers to vaccine Measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study Assessed in nasal wash or nasosorption samples
Trial Locations
- Locations (1)
Johns Hopkins University Center for Immunization Research
🇺🇸Baltimore, Maryland, United States