Phase 1
N=45
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children
RSV Infection
Bottom Line
View on ClinicalTrials.gov: NCT03387137 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants) — 8; 5; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RSV 6120/∆NS2/1030s (Biological); Placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants) |
8; 5; 0; 0; 2; 0 | — |
| PRIMARY Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants) |
14; 8; 1; 1; 4; 1 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seropositive Participants) |
3; 1 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seronegative Participants) |
9; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants) |
0; 0 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants) |
0; 0 | — |
| PRIMARY Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Subjects) |
2; 0 | — |
| PRIMARY Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Subjects) |
20; 0 | — |
| PRIMARY Peak Titer of Vaccine Virus Shed Measured by Culture (RSV-seropositive Subjects) |
1.2 | — |
| PRIMARY Peak Titer of Vaccine Virus Shed Measured by Reverse Transcription Polymerase Chain Reaction (RSV-seropositive Subjects) |
3.1 | — |
| PRIMARY Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seropositive Subjects) |
7.5; 7.5 | — |
| PRIMARY Peak Titer of Vaccine Virus Shed by Culture (RSV-seronegative Subjects) |
3.0 | — |
| PRIMARY Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RSV-seronegative Subjects) |
4.5 | — |
| PRIMARY Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seronegative Subjects) |
10.2; 11.8 | — |
| PRIMARY Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein(RSV-seropositive Subjects) |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein (RSV-seronegative Subjects) |
18; 0; 17; 0 | — |
| PRIMARY RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA)(RSV-seropositive Subjects) |
7.1; 7.2; 12.1; 12.9 | — |
| PRIMARY RSV-neutralizing Serum Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) (RSV-seronegative Subjects) |
6.5; 2.6; 10.9; 6.0 | — |
| SECONDARY Number of RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season |
6; 5 | — |
| SECONDARY 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 First RSV Season |
4; 3 | — |
| SECONDARY 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 First RSV Season |
3; 3; 0; 0; 1; 1 | — |
| SECONDARY Serum RSV-neutralizing Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) in Subjects (RSV-seronegative) Infected With wt RSV During the RSV Surveillance |
6.7; 3.0; 10.7; 8.1; 10.2; 5.4 | — |
| SECONDARY Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titers and/or Serum Antibody Titers to RSV F Glycoprotein in RSV-seronegative Subjects (Group 2) Infected With wt RSV During the RSV Surveillance |
5; 4; 6; 4 | — |
Summary
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine (RSV 6120/∆NS2/1030s) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.
Eligibility Criteria
Inclusion Criteria for RSV-Seropositive Children:
- Greater than or equal to 12 months of age and less than 60 months of age at the time of inoculation
- Screening serum specimen for RSV neutralizing antibody is obtained within the calendar year of inoculation
- Seropositive for RSV antibody, defined as serum RSV neutralizing antibody titer greater than or equal to 1:40
- Pre-inoculation serum sample for RSV neutralizing antibody testing is obtained no more than 56 days prior to inoculation
- In good health based on review of the medical record, history, and physical examination at the time of inoculation
- Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger
- Growing normally for age as demonstrated on a standard growth chart and has a current height and weight above the 3rd percentile for age
- Expected to be available for the duration of the study
- Parent/guardian is willing and able to provide written informed consent
Exclusion Criteria for RSV-Seropositive Children:
- Born at less than 34 weeks gestation
- Maternal history of positive HIV test
- Evidence of chronic disease
- Known or suspected impairment of immune function
- Bone marrow/solid organ transplant recipient
- Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
- 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
- Wheezing episode or received bronchodilator therapy after the age of 12 months
- Previous receipt of supplemental oxygen therapy in a home setting
- Previous receipt of an investigational RSV vaccine
- Previous receipt or planned administration of anti-RSV drug (ribavirin) or RSV antibody product including RSV immune globulin (RSV Ig) or RSV monoclonal antibody (RSV mAb)
- Previous receipt of immunoglobulin or any antibody products within the past 6 months
- Previous receipt of any other blood products within the past 6 months
- Previous anaphylactic reaction
- Previous vaccine-associated adverse reaction that was Grade 3 or above
- Known hypersensitivity to any vaccine component
- Member of a household that contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation
- Member of a household that, at the date of inoculation through the 10th day after inoculation, contains an immunocompromised individual including but not limited to:
- a person who is HIV-infected
- a person who has received chemotherapy within the 12 months prior to enrollment
- a person receiving immunosuppressant agents
- a person living with a solid organ or bone marrow transplant
- Will attend a daycare facility that does not separate children by age and contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation
- Receipt of any of the following prior to enrollment:
- any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
- any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
- another investigational vaccine or investigational drug within 28 days prior, or
- salicylate (aspirin) or salicylate-containing products within the past 28 days
- Scheduled administration of any of the following after planned inoculation:
- inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
- any live vaccine other than rotavirus in the 28 days after, or
- another investigational vaccine or investigational drug in the 28 days after
- Receipt of any of the following medications within 3 days of study enrollment:
- systemic antibacterial, antiv
Data sourced from ClinicalTrials.gov (NCT03387137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.