ClinicalTrials.gg
Sign In
CompletedNCT03387137Updated Dec 11, 2024Results posted

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

A Phase 1 interventional study of RSV 6120/∆NS2/1030s and Placebo in RSV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 6 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
6 Months to 60 Months
Sex
All
01

Study 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.

Read the detailed description

This study will evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated 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.

The vaccine will be evaluated in a stepwise fashion beginning in RSV-seropositive children (Group 1), and then in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of RSV 6120/∆NS2/1030s vaccine or placebo at study entry (Day 0).

Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 (RSV-seropositive children) will be followed for 28 days. Group 2 (RSV-seronegative infants and children) will remain on study until they complete the post-RSV season visit.

Group 2 participants may participate in an optional second season of RSV surveillance during November to March of the second year following 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.

02

Conditions studied

  • RSV Infection
03

In context

Respiratory Syncytial Virus Infections

302 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 48 are open to participants now.

This study's enrollment of 45 is below the median of 89 across 219 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.

Browse National Institute of Allergy and Infectious Diseases (NIAID) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
    • intranasal medications, or
    • other prescription medications except the permitted concomitant medications listed below:
    • Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents.

  • Any of the following events at the time of enrollment:

    • fever (temporal or rectal temperature of greater than or equal to 100.4°F), or
    • upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or
    • nasal congestion significant enough to interfere with successful inoculation, or
    • otitis media

Inclusion Criteria for RSV-Seronegative Infants and Children:

  • Greater than or equal to 6 months of age and less than 25 months of age at the time of inoculation
  • Screening and pre-inoculation serum specimens for RSV-neutralizing antibody are obtained no more than 42 days prior to inoculation
  • Seronegative for RSV antibody, defined as serum RSV-neutralizing antibody titer less than 1:40
  • 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 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

    • If less than 1 year of age: has a current height and weight above the 5th percentile for age
    • If greater than or equal to 1 year of age: 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-Seronegative Infants and Children:

  • Born at less than 34 weeks gestation
  • Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age
  • Maternal history of a positive HIV test
  • Evidence of chronic disease
  • Known or suspected infection or impairment of immunological functions
  • 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 antibody product including ribavirin, RSV Ig, or RSV mAb
  • Previous receipt of immunoglobulin or any antibody products within the past 6 months
  • Previous receipt of any 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 study product component
  • Member of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation

  • Member of a household that, at the date of inoculation through the 28th day after inoculation, contains an immunocompromised individual including but not limited to:

    • a person who is HIV-infected
    • a person who has cancer and has received chemotherapy within the 12 months prior to enrollment
    • a person living with a solid organ or bone marrow transplant
  • Attends a daycare facility that does not separate children by age and contains an infant less than 6 months of age at the date of inoculation through the 28th 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 56 days after

  • Receipt of any of the following medications within 3 days of study enrollment:

    • systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
    • intranasal medications, or
    • other prescription medications except the permitted concomitant medications listed below:
    • Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents.

  • Any of the following events at the time of enrollment:

    • fever (temporal or rectal temperature of greater than or equal to 100.4°F), or
    • upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or
    • nasal congestion significant enough to interfere with successful inoculation, or
    • otitis media

Inclusion Criteria for RSV-Seronegative Children Participating in a Second Season of RSV Surveillance:

  • RSV-seronegative participants who have completed the initial RSV season surveillance portion of the study and whose parent/guardian is willing and able to provide written informed consent
  • Expected to be available during the second year of RSV surveillance

Exclusion Criteria for RSV-Seronegative Children Participating in a Second Season of RSV Surveillance:

  • Currently enrolled in another RSV study
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Group 1: RSV 6120/∆NS2/1030s Vaccine

    RSV-seropositive children will receive a single dose of 10\^5.7 plaque-forming units (PFUs) of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).

    Biological: RSV 6120/∆NS2/1030s

  • Placebo comparator
    Group 1: Placebo

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

    Biological: Placebo

  • Experimental
    Group 2: RSV 6120/∆NS2/1030s Vaccine

    RSV-seronegative infants and children will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS2/1030s vaccine at study entry (Day 0).

    Biological: RSV 6120/∆NS2/1030s

  • Placebo comparator
    Group 2: Placebo

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

    Biological: Placebo

Interventions

  • BiologicalRSV 6120/∆NS2/1030s

    Delivered as nose drops

  • BiologicalPlacebo

    Delivered as nose drops

06

What researchers measure

Primary outcomes

  1. Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)

    Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix IV of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 21 and Table 22 in the protocol document.

    Time frame: Measured through Day 10

  2. Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)

    Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined by Appendix IV in the protocol document . The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 21 and Table 22 in the protocol document.

    Time frame: Measured through Day 28

  3. Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seropositive Participants)

    Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.

    Time frame: Measured through Day 10

  4. Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seronegative Participants)

    Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.

    Time frame: Measured through Day 28

  5. Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)

    A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: * Results in death during the period of protocol-defined surveillance; * Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe; * Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting; * Results in a persistent or significant disability/incapacity; * Is a congenital anomaly or birth defect, OR * Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

    Time frame: Measured through Day 28

  6. Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants)

    A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: * Results in death during the period of protocol-defined surveillance; * Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe; * Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting; * Results in a persistent or significant disability/incapacity; * Is a congenital anomaly or birth defect, OR * Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

    Time frame: Measured through Day 56

  7. Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Subjects)

    As defined as 1) vaccine virus identified in a nasal wash (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) and/or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 28.

    Time frame: Measured through Day 28

  8. Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Subjects)

    As defined as 1) vaccine virus identified in a nasal wash (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) and/or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 56.

    Time frame: Measured through Day 56

  9. Peak Titer of Vaccine Virus Shed Measured by Culture (RSV-seropositive Subjects)

    This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.

    Time frame: Measured at Days 0, 3, 4, 5, 6, 7 and 10

  10. Peak Titer of Vaccine Virus Shed Measured by Reverse Transcription Polymerase Chain Reaction (RSV-seropositive Subjects)

    This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by reverse transcription polymerase chain reaction (RT-PCR). Only participants who met the definition of infection with vaccine virus were included.

    Time frame: Measured at Days 0, 3, 4, 5, 6, 7 and 10

  11. Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seropositive Subjects)

    As determined by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)

    Time frame: Measured at Days 0, 3, 4, 5, 6, 7 and 10. Last day positive is reported.

  12. Peak Titer of Vaccine Virus Shed by Culture (RSV-seronegative Subjects)

    This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.

    Time frame: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28

  13. Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RSV-seronegative Subjects)

    This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by reverse transcription polymerase chain reaction (RT-PCR). Only participants who met the definition of infection with vaccine virus were included.

    Time frame: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28

  14. Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seronegative Subjects)

    As determined by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)

    Time frame: Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28. Lat day positive is reported

  15. 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)

    Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.

    Time frame: Measured at Day 0 and Day 28

  16. 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)

    Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.

    Time frame: Measured at Day 0 and Day 56

  17. RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA)(RSV-seropositive Subjects)

    Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Serum antibody titers to RSV F glycoprotein were assessed by ELISA.

    Time frame: Measured at Day 28

  18. RSV-neutralizing Serum Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) (RSV-seronegative Subjects)

    Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Serum antibody titers to RSV F glycoprotein were assessed by ELISA.

    Time frame: Measured at Day 56

Secondary outcomes

  1. Number of RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season

    As defined as 1) RSV identified in a nasal wash (a binary outcome based on nasal washes done throughout the RSV surveillance period; or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer or Serum IgG RSV F antibody titer from pre- to post-RSV Surveillance season

    Time frame: Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enrolled in the study.

  2. 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

    The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a \> 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events.

    Time frame: Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enroll in the study.

  3. 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

    The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a \> 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each MAARI category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 21 and Table 22 in the protocol document.Assessed by protocol-determined grading system

    Time frame: Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enroll in the study

  4. 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

    Antibodies were assessed by RSV-neutralizing Antibody and Enzyme-linked Immunosorbent Assay (ELISA). A response was defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre- and post-RSV Surveillance time points.

    Time frame: Measured pre- RSV Surveillance period (baseline) and post-RSV Surveillance period (4-6 months after the baseline)

  5. 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

    Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-RSV surveillance and post-RSV surveillance time points among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a \> 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events

    Time frame: Measured pre-RSV Surveillance period (baseline) and post-RSV Surveillance period (4-6 months after the baseline)

07

Results

Posted Aug 3, 2023

Participant flow

Participants were recruited from pediatric practices and clinics in the greater Baltimore/Washington area based on referral by the primary care provider or the provider's staff; and through mailing IRB-approved documents to children of local pediatric practices and clinics, and to households in local zip codes containing age-appropriate children between September 2017 and September 2019. The first participant was enrolled on 10/13/2017 and the last participant was enrolled on 9/27/2019.

Participant flow — Overall Study
MilestoneGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: PlaceboGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Started1052010
Completed1052010
Not completed0000

Outcome measures

PrimaryNumber of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)

Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix IV of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 21 and Table 22 in the protocol document.

Time frame:
Measured through Day 10
Reported as:
Count of participants · Participants
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants)
ParticipantsGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Fever — Did not have this AE85
Fever — Grade 100
Fever — Grade 220
Fever — Grade 300
Fever — Grade 400
Upper Respiratory Illness (URI) — Did not have this AE64
Upper Respiratory Illness (URI) — Grade 141
Upper Respiratory Illness (URI) — Grade 200
Upper Respiratory Illness (URI) — Grade 300
Upper Respiratory Illness (URI) — Grade 400
Lower Respiratory Illness (LRI) with RSV shedding — Did not have this AE105
Lower Respiratory Illness (LRI) with RSV shedding — Grade 100
Lower Respiratory Illness (LRI) with RSV shedding — Grade 200
Lower Respiratory Illness (LRI) with RSV shedding — Grade 300
Lower Respiratory Illness (LRI) with RSV shedding — Grade 400
LRI in the absence of RSV shedding — Did not have this AE95
LRI in the absence of RSV shedding — Grade 100
LRI in the absence of RSV shedding — Grade 210
LRI in the absence of RSV shedding — Grade 300
LRI in the absence of RSV shedding — Grade 400
Cough without LRI — Did not have this AE95
Cough without LRI — Grade 110
Cough without LRI — Grade 200
Cough without LRI — Grade 300
Cough without LRI — Grade 400
Otitis Media — Did not have this AE105
Otitis Media — Grade 100
Otitis Media — Grade 200
Otitis Media — Grade 300
Otitis Media — Grade 400
PrimaryNumber of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)

Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined by Appendix IV in the protocol document . The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 21 and Table 22 in the protocol document.

Time frame:
Measured through Day 28
Reported as:
Count of participants · Participants
Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seronegative Participants)
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Fever — Did not have this AE148
Fever — Grade 111
Fever — Grade 241
Fever — Grade 310
Fever — Grade 400
Upper Respiratory Illness (URI) — Did not have this AE26
Upper Respiratory Illness (URI) — Grade 1184
Upper Respiratory Illness (URI) — Grade 200
Upper Respiratory Illness (URI) — Grade 300
Upper Respiratory Illness (URI) — Grade 400
Lower Respiratory Illness (LRI) with RSV shedding — Did not have this AE1910
Lower Respiratory Illness (LRI) with RSV shedding — Grade 100
Lower Respiratory Illness (LRI) with RSV shedding — Grade 210
Lower Respiratory Illness (LRI) with RSV shedding — Grade 300
Lower Respiratory Illness (LRI) with RSV shedding — Grade 400
LRI in the absence of RSV shedding — Did not have this AE1910
LRI in the absence of RSV shedding — Grade 100
LRI in the absence of RSV shedding — Grade 210
LRI in the absence of RSV shedding — Grade 300
LRI in the absence of RSV shedding — Grade 400
Cough, without LRI — Did not have this AE149
Cough, without LRI — Grade 151
Cough, without LRI — Grade 210
Cough, without LRI — Grade 300
Cough, without LRI — Grade 400
Otitis Media — Did not have this AE1910
Otitis Media — Grade 100
Otitis Media — Grade 210
Otitis Media — Grade 300
Otitis Media — Grade 400
PrimaryNumber of Participants With Unsolicited Adverse Events (AEs) - (RSV-seropositive Participants)

Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.

Time frame:
Measured through Day 10
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seropositive Participants)
ParticipantsGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seropositive Participants)31
PrimaryNumber of Participants With Unsolicited Adverse Events (AEs) - (RSV-seronegative Participants)

Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.

Time frame:
Measured through Day 28
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seronegative Participants)
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Number of Participants With Unsolicited Adverse Events (AEs) - (RSV-seronegative Participants)93
PrimaryNumber of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)

A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: * Results in death during the period of protocol-defined surveillance; * Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe; * Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting; * Results in a persistent or significant disability/incapacity; * Is a congenital anomaly or birth defect, OR * Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

Time frame:
Measured through Day 28
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)
ParticipantsGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)00
PrimaryNumber of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants)

A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: * Results in death during the period of protocol-defined surveillance; * Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe; * Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting; * Results in a persistent or significant disability/incapacity; * Is a congenital anomaly or birth defect, OR * Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

Time frame:
Measured through Day 56
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants)
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants)00
PrimaryFrequency of Infection With RSV Vaccine Virus (RSV-seropositive Subjects)

As defined as 1) vaccine virus identified in a nasal wash (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) and/or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 28.

Time frame:
Measured through Day 28
Reported as:
Count of participants · Participants
Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Subjects)
ParticipantsGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Subjects)20
PrimaryFrequency of Infection With RSV Vaccine Virus (RSV-seronegative Subjects)

As defined as 1) vaccine virus identified in a nasal wash (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) and/or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 56.

Time frame:
Measured through Day 56
Reported as:
Count of participants · Participants
Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Subjects)
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Frequency of Infection With RSV Vaccine Virus (RSV-seronegative Subjects)200
PrimaryPeak Titer of Vaccine Virus Shed Measured by Culture (RSV-seropositive Subjects)

This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.

Time frame:
Measured at Days 0, 3, 4, 5, 6, 7 and 10
Reported as:
Mean · log 10 PFU/mL
Peak Titer of Vaccine Virus Shed Measured by Culture (RSV-seropositive Subjects)
log 10 PFU/mLGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Peak Titer of Vaccine Virus Shed Measured by Culture (RSV-seropositive Subjects)1.2 ± 0.5—
PrimaryPeak Titer of Vaccine Virus Shed Measured by Reverse Transcription Polymerase Chain Reaction (RSV-seropositive Subjects)

This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by reverse transcription polymerase chain reaction (RT-PCR). Only participants who met the definition of infection with vaccine virus were included.

Time frame:
Measured at Days 0, 3, 4, 5, 6, 7 and 10
Reported as:
Mean · log 10 copies/mL
Peak Titer of Vaccine Virus Shed Measured by Reverse Transcription Polymerase Chain Reaction (RSV-seropositive Subjects)
log 10 copies/mLGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Peak Titer of Vaccine Virus Shed Measured by Reverse Transcription Polymerase Chain Reaction (RSV-seropositive Subjects)3.1 ± 0.9—
PrimaryDuration of Vaccine Virus Shedding in Nasal Washes (RSV-seropositive Subjects)

As determined by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)

Time frame:
Measured at Days 0, 3, 4, 5, 6, 7 and 10. Last day positive is reported.
Reported as:
Mean · Days
Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seropositive Subjects)
DaysGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Culture Positive7.5 (5 to 10)—
RT-PCR Positive7.5 (5 to 10)—
PrimaryPeak Titer of Vaccine Virus Shed by Culture (RSV-seronegative Subjects)

This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.

Time frame:
Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28
Reported as:
Mean · log 10 PFU/mL
Peak Titer of Vaccine Virus Shed by Culture (RSV-seronegative Subjects)
log 10 PFU/mLGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Peak Titer of Vaccine Virus Shed by Culture (RSV-seronegative Subjects)3.0 ± 0.8—
PrimaryPeak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RSV-seronegative Subjects)

This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by reverse transcription polymerase chain reaction (RT-PCR). Only participants who met the definition of infection with vaccine virus were included.

Time frame:
Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28
Reported as:
Mean · log 10 copies/mL
Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RSV-seronegative Subjects)
log 10 copies/mLGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RSV-seronegative Subjects)4.5 ± 0.8—
PrimaryDuration of Vaccine Virus Shedding in Nasal Washes (RSV-seronegative Subjects)

As determined by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)

Time frame:
Measured at Days 0, 3, 5, 7, 10, 12, 14, 17 and 28. Lat day positive is reported
Reported as:
Mean · Days
Duration of Vaccine Virus Shedding in Nasal Washes (RSV-seronegative Subjects)
DaysGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Culture Positive10.2 (7 to 14)—
RT-PCR Positive11.8 (7 to 17)—
PrimaryNumber 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)

Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.

Time frame:
Measured at Day 0 and Day 28
Reported as:
Count of participants · Participants
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)
ParticipantsGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Serum RSV Neutralizing Antibody Titers00
Serum IgG ELISA RSV F Antibody Interpolated Titers00
PrimaryNumber 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)

Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.

Time frame:
Measured at Day 0 and Day 56
Reported as:
Count of participants · Participants
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)
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Serum RSV Neutralizing Antibody Titers180
Serum IgG ELISA RSV F Antibody Interpolated Titers170
PrimaryRSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA)(RSV-seropositive Subjects)

Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Serum antibody titers to RSV F glycoprotein were assessed by ELISA.

Time frame:
Measured at Day 28
Reported as:
Mean · log 2 titers
RSV-neutralizing Serum Antibody Titer and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA)(RSV-seropositive Subjects)
log 2 titersGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: Placebo
Serum RSV Neutralizing Antibody Titers7.1 ± 1.07.2 ± 0.7
Serum IgG ELISA RSV F Antibody Interpolated Titers12.1 ± 1.512.9 ± 0.5
PrimaryRSV-neutralizing Serum Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) (RSV-seronegative Subjects)

Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Serum antibody titers to RSV F glycoprotein were assessed by ELISA.

Time frame:
Measured at Day 56
Reported as:
Mean · log 2 titers
RSV-neutralizing Serum Antibody Titers and Immunoglobulin G (IgG) Serum Antibody Titers to RSV F Glycoprotein Enzyme-linked Immunosorbent Assay (ELISA) (RSV-seronegative Subjects)
log 2 titersGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Serum RSV Neutralizing Antibody Titers6.5 ± 1.12.6 ± 0.6
Serum IgG ELISA RSV F Antibody Interpolated Titers10.9 ± 1.76.0 ± 2.0
SecondaryNumber of RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season

As defined as 1) RSV identified in a nasal wash (a binary outcome based on nasal washes done throughout the RSV surveillance period; or 2) a greater than or equal to 4-fold rise in RSV neutralizing antibody titer or Serum IgG RSV F antibody titer from pre- to post-RSV Surveillance season

Time frame:
Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enrolled in the study.
Reported as:
Count of participants · Participants
Number of RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Number of RSV-seronegative (Group 2) Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the First RSV Season65
SecondaryFrequency 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

The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a \> 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events.

Time frame:
Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enroll in the study.
Reported as:
Count of participants · Participants
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
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
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 Season43
SecondarySeverity 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

The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a \> 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each MAARI category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 21 and Table 22 in the protocol document.Assessed by protocol-determined grading system

Time frame:
Measured through participants' last study visit, up to a total of 6 to 13 months after study entry, depending on when participants enroll in the study
Reported as:
Count of participants · Participants
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
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Medically Attended Fever — No adverse event33
Medically Attended Fever — Grade 100
Medically Attended Fever — Grade 211
Medically Attended Fever — Grade 321
Medically Attended Fever — Grade 400
Medically Attended URI — No adverse event21
Medically Attended URI — Grade 100
Medically Attended URI — Grade 244
Medically Attended URI — Grade 300
Medically Attended URI — Grade 400
Medically Attended LRI — No adverse event45
Medically Attended LRI — Grade 100
Medically Attended LRI — Grade 220
Medically Attended LRI — Grade 300
Medically Attended LRI — Grade 400
Medically Attended Cough — No adverse event32
Medically Attended Cough — Grade 100
Medically Attended Cough — Grade 233
Medically Attended Cough — Grade 300
Medically Attended Cough — Grade 400
Medically Attended Otitis Media — No adverse event44
Medically Attended Otitis Media — Grade 100
Medically Attended Otitis Media — Grade 221
Medically Attended Otitis Media — Grade 300
Medically Attended Otitis Media — Grade 400
SecondarySerum 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

Antibodies were assessed by RSV-neutralizing Antibody and Enzyme-linked Immunosorbent Assay (ELISA). A response was defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre- and post-RSV Surveillance time points.

Time frame:
Measured pre- RSV Surveillance period (baseline) and post-RSV Surveillance period (4-6 months after the baseline)
Reported as:
Mean · log 2 titers
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
log 2 titersGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Pre-RSV Surveillance Serum RSV Neutralizing Antibody6.7 ± 1.43.0 ± 0.8
Post-RSV Surveillance Serum RSV Neutralizing Antibody10.7 ± 1.78.1 ± 1.0
Pre-RSV Surveillance Serum IgG ELISA RSV F Antibody Interpolated Titers10.2 ± 1.95.4 ± 1.7
Post-RSV Surveillance Serum IgG ELISA RSV F Antibody Interpolated Titers14.3 ± 1.411.8 ± 1.3
SecondaryNumber 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

Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay and an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-RSV surveillance and post-RSV surveillance time points among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal washes collected during illness visits for MAARI events or a \> 4-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events

Time frame:
Measured pre-RSV Surveillance period (baseline) and post-RSV Surveillance period (4-6 months after the baseline)
Reported as:
Count of participants · Participants
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
ParticipantsGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
Serum RSV Neutralizing Antibody54
Serum IgG ELISA RSV F Antibody Interpolated Titers64

Adverse events

Collected over From study entry to end of study. The duration of follow-up for a given participant was 2 months for Group 1 and between 6 and 10 months for Group 2 depending on time of enrollment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: RSV 6120/∆NS2/1030s Vaccine0/10 (0%)0/10 (0%)6/10 (60%)
Group 1: Placebo0/5 (0%)0/5 (0%)2/5 (40%)
Group 2: RSV 6120/∆NS2/1030s Vaccine0/20 (0%)0/20 (0%)20/20 (100%)
Group 2: Placebo0/10 (0%)0/10 (0%)9/10 (90%)
Most frequent other events
Showing 10 of 20
Most frequent other events
EventGroup 1: RSV 6120/∆NS2/1030s VaccineGroup 1: PlaceboGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: Placebo
RhinorrhoeaRespiratory, thoracic and mediastinal disorders4/101/519/208/10
CoughRespiratory, thoracic and mediastinal disorders1/100/59/209/10
PyrexiaGeneral disorders2/100/59/206/10
Otitis MediaInfections and infestations0/100/55/203/10
EpistaxisRespiratory, thoracic and mediastinal disorders0/101/50/200/10
RashSkin and subcutaneous tissue disorders0/100/53/202/10
PainGeneral disorders1/100/53/200/10
Nasal CongestionRespiratory, thoracic and mediastinal disorders1/100/53/201/10
StomatitisGastrointestinal disorders0/100/52/200/10
General DiscomfortGeneral disorders1/100/50/200/10

Baseline characteristics

Age, Customized
Age, Customized(Participants)Group 1: RSV 6120/∆NS2/1030s VaccineGroup 1: PlaceboGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: PlaceboTotal
< 1 year of age007512
1 year of age6112524
2 years of age12104
3 years of age20002
4 years of age12003
> 4 years of age00000
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: RSV 6120/∆NS2/1030s VaccineGroup 1: PlaceboGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: PlaceboTotal
Female6411324
Male419721
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1: RSV 6120/∆NS2/1030s VaccineGroup 1: PlaceboGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: PlaceboTotal
Hispanic or Latino00202
Not Hispanic or Latino105181043
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: RSV 6120/∆NS2/1030s VaccineGroup 1: PlaceboGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: PlaceboTotal
American Indian or Alaska Native00000
Asian21104
Native Hawaiian or Other Pacific Islander00000
Black or African American10102
White6116932
More than one race13217
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)Group 1: RSV 6120/∆NS2/1030s VaccineGroup 1: PlaceboGroup 2: RSV 6120/∆NS2/1030s VaccineGroup 2: PlaceboTotal
United States105201045
08

Study locations

1 site
  • Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health
    Baltimore, Maryland 21205, United States
09

References and documents

Publications

  • Karron RA, Luongo C, Woods S, Oliva J, Collins PL, Buchholz UJ; RSVPed Team. Evaluation of the Live-Attenuated Intranasal Respiratory Syncytial Virus (RSV) Vaccine RSV/6120/DeltaNS2/1030s in RSV-Seronegative Young Children. J Infect Dis. 2024 Feb 14;229(2):346-354. doi: 10.1093/infdis/jiad281. PubMed 37493269 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 6, 2020
  • Informed consent form · May 8, 2020
  • Informed consent form · Mar 16, 2018

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Nov 2019, 25 months.

Results were first posted in Aug 2023, 3 years 8 months after primary completion.

Of 57 phase 1 interventional studies under Respiratory Syncytial Virus Infections, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 17. This study's 25 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2017
First posted
Dec 29, 2017
StartActual
Oct 13, 2017
Primary completionActual
Nov 22, 2019
CompletionActual
May 31, 2021
Results first posted
Aug 3, 2023
Last update
Dec 11, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03387137
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Dec 29, 2017
Start date
Oct 13, 2017
Primary completion
Nov 22, 2019
Completion
May 31, 2021
Results posted
Aug 3, 2023
Last update
Dec 11, 2024

Study contacts

Ruth A. Karron, MD
principal investigator · Johns Hopkins Bloomberg School of Public Health (JHSPH)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Respiratory Syncytial Virus Infections →

Other studies from this sponsor

National Institute of Allergy and Infectious Diseases (NIAID) →

Start the discussion