Respiratory Syncytial Virus InfectionsPhase 1NCT01893554
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children
A Phase 1 study testing RSV ΔNS2 Δ1313 I1314L Vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants… Read more about this study
- Who is it for?
- Ages 4 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSV ΔNS2 Δ1313 I1314L Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2013to 26 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children at least 12 but less than 60 months of age, whose parent/guardian understands and signs the study informed consent and who agrees to vaccine administration following a detailed explanation of the study
- Seropositive for RSV as defined by serum RSV neutralizing antibody titer equal to or greater than 1:40. If a child at least 12 but less than 60 months of age is determined to be RSV seropositive prior to Day 56, s/he does not need an additional screening serum specimen, but a pre-inoculation serum specimen must be obtained.
- Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health
- Participant is expected to be available for the duration of the study
- Healthy children at least 6 but less than 25 months of age whose parents/guardians can understand and sign the informed consent and who agree to vaccine administration following detailed explanation of the study
- Seronegative for RSV antibody, defined as a serum RSV neutralizing antibody titer less than 1:40 as determined not more than 42 days prior to inoculation
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- Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.
- Participant is expected to be available for the duration of the study
- Healthy infants 4 to 6 months of age whose parents/guardians can understand and sign the informed consent and who agree to vaccine administration following detailed explanation of the study.
- Subject's history has been reviewed and subject has undergone a physical examination indicating that s/he is in good health. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents.
- Subject is expected to be available for the duration of the study.
- Those children who have completed the initial study and whose parents/guardians can understand and sign the informed consent.
- Subject is expected to be available during the second year of RSV surveillance.
Who cannot join
- Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids, or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product.
- Previous serious vaccine-associated AE or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Lung or heart disease, including any wheezing event or reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
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- Member of a household that includes an immunocompromised individual or infants less than 6 months of age, other than a study participant
- Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Note: children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
- Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids, or bone marrow/solid organ transplant recipients
- Major congenital malformations including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product.
- Previous serious vaccine-associated AE or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Lung or heart disease, including any wheezing event or reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
- Member of a household that includes an immunocompromised individual or infants less than 6 months of age
- Attends daycare with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
- Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids or bone marrow/solid organ transplant recipients.
- Major congenital malformations including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders.
- Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product.
- Previous serious vaccine-associated AE or anaphylactic reaction.
- Known hypersensitivity to any vaccine component.
- Lung or heart disease, including any wheezing event or reactive airway disease. Subjects with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled.
- Member of a household that includes an immunocompromised individual or infants less than 4 months of age.
- Attends daycare with infants less than 4 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
- Temporary Exclusion Criteria for Seropositive Children, Seronegative Children, and Infants:
- The following are temporary or self-limiting conditions, and once resolved, the subject may be enrolled, if otherwise eligible. If the period of temporary exclusion is greater than 42 days, seronegative children will need to be rescreened for levels of RSV neutralizing antibody.
- Fever (rectal temperature of greater than or equal to 100.4°F [38°C]), or upper respiratory illness (rhinorrhea, cough, or pharyngitis) or nasal congestion significant enough to interfere with successful vaccination, or otitis media
- Subject has received any killed vaccine or live attenuated rotavirus vaccine within 14 days prior to inoculation, any other live vaccine within 28 days prior to inoculation, or gamma globulin (or other antibody products) within the past 3 months prior to inoculation.
- Receipt of another investigational vaccine or investigational drug 28 days prior to receiving this investigational RSV vaccine
- Has received antibiotics or systemic or nasal steroid therapy for acute illness within the previous 3 days prior to vaccination (steroid skin creams or lotions and topical antibiotics or antifungal preparations are permitted)
- Has received salicylate (aspirin) or salicylate-containing products within 28 days prior to inoculation
- Children born at less than 37 weeks gestation and less than 1 year of age
- Currently enrolled in another RSV study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Immunization Research (CIR)
Baltimore, Maryland, 21205
Center for Immunization Research South
Laurel, Maryland, 20708
About this study
Official title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV ΔNS2 Δ1313 I1314L, Lot RSV#006A, Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age, RSV-Seronegative Infants and Children 6 to 24 Months of Age, and Infants 4 to 6 Months of Age
Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.
Read the detailed description
RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age around the world. RSV illness can range from mild upper respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia. The purpose of this study is to evaluate the safety and immunogenicity of a single dose of a RSV vaccine in healthy children. Study researchers will first evaluate the vaccine in healthy RSV-seropositive children, then evaluate the vaccine in healthy RSV-seronegative infants and children, followed by younger infants not screened for RSV serostatus.
This study will first enroll healthy RSV-seropositive children ages 12 to 59 months (Group 1). At study entry, participants will undergo a medical history review, physical examination, blood collection, and a nasal wash procedure. Participants will be randomly assigned to receive either the RSV vaccine or placebo vaccine, administered as nose drops. Subjects will be actively monitored for 28 days following administration of vaccine or placebo; monitoring will include medical history reviews, clinical assessments, and at some visits, nasal washes. On the days where no study visit is scheduled, study researchers will contact participants' parents or guardians for medical follow-up.
Study researchers will evaluate the study data of participants in Group 1 before enrolling participants in Group 2, and study data from Group 2 will be reviewed before enrolling participants in Group 3. Finally, study data from Group 3 will be reviewed before enrolling participants in Group 4. Participants in Groups 2 and 3 will include healthy RSV-seronegative infants and children ages 6 to 24 months. Participants in Group 4 will include healthy infants, ages 4 to 6 months, who have not been screened for RSV serostatus.
Participants in Groups 2, 3, and 4 will be randomly assigned to receive either the RSV vaccine or placebo vaccine, administered as nose drops. Subjects will be actively monitored for 56 days following administration of vaccine or placebo; monitoring will include medical history reviews, clinical assessments, and at some visits, nasal washes. On the days where no study visit is scheduled, study researchers will contact participants' parents or guardians for medical follow-up. At a study visit on Day 56, participants will undergo a medical history review, blood collection, and a nasal wash procedure.
For participants in Groups 2, 3, and 4, from November through March following each participant's vaccination visit, parents or guardians will monitor participants for RSV-associated illnesses and report these on a weekly basis via telephone calls to study researchers. Participants may have additional study visits that may include blood collection and/or nasal wash procedures during this follow-up period. Participants in Groups 3 and 4 will have the option to take part in additional monitoring for a second RSV season.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RSV ΔNS2 Δ1313 I1314L Vaccine, Placebo
- Keywords
- RSV
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV ΔNS2 Δ1313 I1314L VaccineBiological
For participants in Groups 1, 3, and 4: 10^6 plaque forming units (PFU) of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL).
For participants in Group 2: 10^5 PFU of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL).
PlaceboBiological
Placebo will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL).
| Study group | Role | What they receive |
|---|---|---|
| Group 1: RSV vaccine | Experimental | Healthy RSV-seropositive children ages 12 to 59 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry. Receives: Biological: RSV ΔNS2 Δ1313 I1314L Vaccine |
| Group 1: Placebo | Placebo comparator | Healthy RSV-seropositive children ages 12 to 59 months will receive one dose of the placebo administered as nose drops at study entry. Receives: Biological: Placebo |
| Group 2: RSV vaccine | Experimental | Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry. Receives: Biological: RSV ΔNS2 Δ1313 I1314L Vaccine |
| Group 2: Placebo | Placebo comparator | Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry. Receives: Biological: Placebo |
| Group 3: RSV vaccine | Experimental | Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry. Receives: Biological: RSV ΔNS2 Δ1313 I1314L Vaccine |
| Group 3: Placebo | Placebo comparator | Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry. Receives: Biological: Placebo |
| Group 4: RSV vaccine | Experimental | Healthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry. Receives: Biological: RSV ΔNS2 Δ1313 I1314L Vaccine |
| Group 4: Placebo | Placebo comparator | Healthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the placebo administered as nose drops at study entry. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study
Measured: Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children
Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination
Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA).
Measured: Measured through follow-up period, up to 1 year after study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study start1 Jun 2013
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Ruth A. Karron, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893554
- Sponsor's protocol ID
- CIR 288
- Other IDs
- CIR 288
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2013
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Karron RA, Luongo C, Mateo JS, Wanionek K, Collins PL, Buchholz UJ. Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/DeltaNS2/Delta1313/I1314L in RSV-Seronegative Children. J Infect Dis. 2020 Jun 16;222(1):82-91. doi: 10.1093/infdis/jiz408.
PubMed 31605113
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV ΔNS2 Δ1313 I1314L, Lot RSV#006A, Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age, RSV-Seronegative Infants and Children 6 to 24 Months of Age, and Infants 4 to 6 Months of Age
- ClinicalTrials.gov ID
- NCT01893554
- Acronym / sponsor ID
- CIR 288
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.
Detailed description
RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age around the world. RSV illness can range from mild upper respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia. The purpose of this study is to evaluate the safety and immunogenicity of a single dose of a RSV vaccine in healthy children. Study researchers will first evaluate the vaccine in healthy RSV-seropositive children, then evaluate the vaccine in healthy RSV-seronegative infants and children, followed by younger infants not screened for RSV serostatus.
This study will first enroll healthy RSV-seropositive children ages 12 to 59 months (Group 1). At study entry, participants will undergo a medical history review, physical examination, blood collection, and a nasal wash procedure. Participants will be randomly assigned to receive either the RSV vaccine or placebo vaccine, administered as nose drops. Subjects will be actively monitored for 28 days following administration of vaccine or placebo; monitoring will include medical history reviews, clinical assessments, and at some visits, nasal washes. On the days where no study visit is scheduled, study researchers will contact participants' parents or guardians for medical follow-up.
Study researchers will evaluate the study data of participants in Group 1 before enrolling participants in Group 2, and study data from Group 2 will be reviewed before enrolling participants in Group 3. Finally, study data from Group 3 will be reviewed before enrolling participants in Group 4. Participants in Groups 2 and 3 will include healthy RSV-seronegative infants and children ages 6 to 24 months. Participants in Group 4 will include healthy infants, ages 4 to 6 months, who have not been screened for RSV serostatus.
Participants in Groups 2, 3, and 4 will be randomly assigned to receive either the RSV vaccine or placebo vaccine, administered as nose drops. Subjects will be actively monitored for 56 days following administration of vaccine or placebo; monitoring will include medical history reviews, clinical assessments, and at some visits, nasal washes. On the days where no study visit is scheduled, study researchers will contact participants' parents or guardians for medical follow-up. At a study visit on Day 56, participants will undergo a medical history review, blood collection, and a nasal wash procedure.
For participants in Groups 2, 3, and 4, from November through March following each participant's vaccination visit, parents or guardians will monitor participants for RSV-associated illnesses and report these on a weekly basis via telephone calls to study researchers. Participants may have additional study visits that may include blood collection and/or nasal wash procedures during this follow-up period. Participants in Groups 3 and 4 will have the option to take part in additional monitoring for a second RSV season.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1: RSV vaccine | Experimental | Biological: RSV ΔNS2 Δ1313 I1314L VaccineHealthy RSV-seropositive children ages 12 to 59 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry. |
| Group 1: Placebo | Placebo comparator | Biological: PlaceboHealthy RSV-seropositive children ages 12 to 59 months will receive one dose of the placebo administered as nose drops at study entry. |
| Group 2: RSV vaccine | Experimental | Biological: RSV ΔNS2 Δ1313 I1314L VaccineHealthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry. |
| Group 2: Placebo | Placebo comparator | Biological: PlaceboHealthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry. |
| Group 3: RSV vaccine | Experimental | Biological: RSV ΔNS2 Δ1313 I1314L VaccineHealthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry. |
| Group 3: Placebo | Placebo comparator | Biological: PlaceboHealthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry. |
| Group 4: RSV vaccine | Experimental | Biological: RSV ΔNS2 Δ1313 I1314L VaccineHealthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry. |
| Group 4: Placebo | Placebo comparator | Biological: PlaceboHealthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the placebo administered as nose drops at study entry. |
Who may qualify
- Ages
- 4 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Healthy children at least 12 but less than 60 months of age, whose parent/guardian understands and signs the study informed consent and who agrees to vaccine administration following a detailed explanation of the study
- Seropositive for RSV as defined by serum RSV neutralizing antibody titer equal to or greater than 1:40. If a child at least 12 but less than 60 months of age is determined to be RSV seropositive prior to Day 56, s/he does not need an additional screening serum specimen, but a pre-inoculation serum specimen must be obtained.
- Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health
- Participant is expected to be available for the duration of the study
- Healthy children at least 6 but less than 25 months of age whose parents/guardians can understand and sign the informed consent and who agree to vaccine administration following detailed explanation of the study
Key exclusion criteria (33 listed)
- Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids, or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product.
- Previous serious vaccine-associated AE or anaphylactic reaction
- Known hypersensitivity to any vaccine component
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV ΔNS2 Δ1313 I1314L VaccineFor participants in Groups 1, 3, and 4: 10^6 plaque forming units (PFU) of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL). For participants in Group 2: 10^5 PFU of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL). | Biological | Group 1: RSV vaccine, Group 2: RSV vaccine, Group 3: RSV vaccine, Group 4: RSV vaccine |
| PlaceboPlacebo will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL). | Biological | Group 1: Placebo, Group 2: Placebo, Group 3: Placebo, Group 4: Placebo |
Primary outcome
Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study
Time frame: Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children
Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination
Time frame: Measured through follow-up period, up to 1 year after study entry
Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 31605113Karron RA, Luongo C, Mateo JS, Wanionek K, Collins PL, Buchholz UJ. Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/DeltaNS2/Delta1313/I1314L in RSV-Seronegative Children. J Infect Dis. 2020 Jun 16;222(1):82-91. doi: 10.1093/infdis/jiz408.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth A. Karron, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RSV ΔNS2 Δ1313 I1314L Vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study (time frame: Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.