Respiratory Syncytial Virus (RSV)Phase 1/2NCT03916185

Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age

A Phase 1/2 study testing RSV ΔNS2/Δ1313/I1314L Vaccine, RSV 6120/ΔNS2/1030s Vaccine and RSV 276 Vaccine in people with Respiratory Syncytial Virus (RSV), run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study was to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age. Read more about this study

Who is it for?: Ages 6 to 25 monthsHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus (RSV)
What is being tested?: RSV ΔNS2/Δ1313/I1314L Vaccine, RSV 6120/ΔNS2/1030s Vaccine and RSV 276 Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 14 sitesUnited States
Study dates: 20 Jun 2019to 25 Apr 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 25 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease.
Parent/guardian is willing and able to provide written informed consent as described in the study protocol.
Seronegative for RSV antibody, defined as a serum RSV-neutralizing antibody titer less than 1:40 at screening from a sample collected no more than 42 days prior to study product administration.
Note: results from specimens collected during screening for any study of an RSV vaccine developed by the Laboratory of Infectious Diseases (LID) (National Institute of Allergy and Infectious Diseases [NIAID], National Institutes of Health [NIH]) are acceptable. If study product will not be administered the same day as randomization (see the study protocol), it must be administered no more than 42 days after the screening sample is collected.
Growing normally for age in the opinion of the site clinician in the six months prior to enrollment AND has a current height and weight above the 3rd percentile for age and sex per Centers for Disease Control and Prevention (CDC) World Health Organization (WHO) growth standards.
Has received routine immunizations appropriate for age (as per national Center for Disease Control Advisory Committee on Immunization Practices [ACIP]). Note: COVID-19 vaccination will not be required unless fully licensed for this age group and ACIP-recommended. See study-specific Manual of Procedures for further guidance
Is expected to be available for the duration of the study.
If born to an HIV-infected woman, potential participant must have documentation of 2 negative HIV nucleic acid (RNA or DNA) test results from samples collected on different dates with both collected when greater than or equal to 4 weeks of age and at least one collected when greater than or equal to 16 weeks of age, and no positive HIV nucleic acid (RNA or DNA) test; or 2 negative HIV antibody tests, both from samples collected at greater than or equal to 24 weeks of age. If potential participant was breastfed by an HIV-infected woman, each of the sampling times noted above must be measured in weeks after the last exposure to breast milk, rather than weeks of age.

Who cannot join

Prior laboratory-confirmed RSV infection.
Known or suspected HIV infection or impairment of immunological functions.
Receipt of immunosuppressive therapy, including any systemic, nasal, or inhaled corticosteroids within 28 days of enrollment. Note: Cutaneous (topical) steroid treatment is not an exclusion.
Any receipt of bone marrow/solid organ transplant.
Major congenital malformations (such as congenital cleft palate) or cytogenetic abnormalities.
Previous enrollment in this trial, previous pediatric receipt of a licensed or investigational RSV vaccine, or previous maternal or pediatric receipt of or planned administration of any other anti-RSV product (such as ribavirin or RSV IG or RSV monoclonal antibody [mAb]) within 4 months of screening or planned administration of an anti-RSV product between screening and day 56 after enrollment.

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Any previous anaphylactic reaction.
Any known hypersensitivity to any study product component.
Heart disease. Note: Potential participants with cardiac abnormalities documented to be clinically insignificant and requiring no treatment may be enrolled.
Lung disease, including any history of reactive airway disease or medically diagnosed wheezing.
Member of a household that contains a person with chronic lung disease, including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, or home oxygen use, reactive airway disease or asthma. Note: Asthma or reactive airway disease in a household member is not exclusionary unless the household member has taken oral steroids for asthma management in the past month and/or has been hospitalized for asthma in the past month.
Member of a household that contains, or will contain, an infant who is less than 4 months of age at the enrollment date through Day 14.
Member of a household that contains another child/other children who is/are enrolled or is/are scheduled to be enrolled in IMPAACT 2021 on a different date and has/have not completed the Day 56 visit in the same calendar year (i.e., all eligible children from the same household must be enrolled/receive study product on the same date or additional children in the household may be screened, enrolled, and randomized independently after other children in the household complete the Day 56 Visit).
Member of a household that contains another child who is, or is scheduled to be, enrolled in another study evaluating an intranasal live-attenuated RSV vaccine, AND there has been or will be an overlap in residency during Day 0 to 14 of that other child's participation in the study.
Member of a household that contains an immunocompromised individual, including, but not limited to:
a person who has been diagnosed with cancer and who has received chemotherapy within the 12 months prior to enrollment; or
a person living with a solid organ, cord blood, or bone marrow transplant.
Shares a daycare room with infants less than 4 months of age, and parent/guardian is unable or unwilling to suspend daycare for 14 days following study product administration.
Any of the following events at the time of enrollment:
fever (rectal temperature of greater than or equal to 100.4°F (38°C)), or
upper respiratory signs or symptoms (including but not limited to rhinorrhea, cough, or pharyngitis) or
nasal congestion significant enough to interfere with successful study product administration, or
otitis media.
Note: if participant is randomized and subsequently noted to have any of the above, study product administration must be deferred per the study protocol.
Receipt of the following prior to enrollment (start counting backwards with '1' as the day of planned study product administration):
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. Note: if COVID-19 vaccine has EUA approval and ACIP recommendation for this age group, it is not considered investigational
Scheduled administration of the following after planned study product administration (start counting with '1' as the day of planned study product administration):
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. Note: if COVID-19 vaccine has EUA approval and ACIP recommendation for this age group, it is not considered investigational.
Receipt of immunoglobulin, any antibody products, or any blood products within the past 6 months prior to enrollment
Receipt of any of the following medications within 3 days prior to study enrollment:
systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
intranasal medications, or
other prescription medication except as 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.
Born at less than 34 weeks gestation.
Born between 34 weeks gestation and 36 weeks and 6 days gestation and less than 1 year of age at the time of enrollment.
Current suspected or documented developmental disorder, delay, or other developmental problem.
Any previous receipt of supplemental oxygen therapy in a home setting.
Known or suspected SARS-CoV-2 exposure within the 14 days prior to enrollment. Note: known or suspected SARS-CoV-2 includes a known asymptomatic household member under quarantine for SARS-CoV-2 exposure but without a positive SARS-CoV-2 test.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Emory University School of Medicine NICHD CRS
Atlanta, Georgia, 30322
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045
University of Maryland School of Medicine Center for Vaccine Development CRS
Baltimore, Maryland, 21201
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, 60612
Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, 60614-3393
Gamble Center for Clinical Studies CRS
Cincinnati, Ohio, 45229
Duke Vaccine and Trials Unit CRS
Durham, North Carolina, 27703
Baylor College of Medicine/ Texas Children's Hospital NICHD CRS
Houston, Texas, 77030
The Children's Mercy Hospital CRS
Kansas City, Missouri, 64108-4619
David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, 90095-1752
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
San Diego, California, 92103
Center for Vaccine Development CRS
St Louis, Missouri, 63104
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age

Read the detailed description

This study evaluated the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.

Participants were randomly assigned to receive a single dose of RSV ΔNS2/Δ1313/I1314L vaccine, RSV 6120/ΔNS2/1030s vaccine, RSV 276 vaccine, or placebo intranasally at study entry.

Participants were enrolled in the study outside of RSV season. All participants were to remain on study until they completed the post-RSV season visit in the calendar year following enrollment. Participants' total study duration was expected to be between 5 and 15 months, depending on when they enrolled in the study and accommodations given for the COVID pandemic.

Participants attended several study visits throughout the study, which included physical examinations, blood collection, and nasal washes or swabs, if applicable. Participants' parents or guardians were contacted by study staff at various times during the study to monitor participants' health.

The study closed to enrollment prior to fully accruing due to difficulties with slower than expected accrual.

Conditions: Respiratory Syncytial Virus (RSV)
Being tested: RSV ΔNS2/Δ1313/I1314L Vaccine, RSV 6120/ΔNS2/1030s Vaccine, RSV 276 Vaccine, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSV ΔNS2/Δ1313/I1314L VaccineBiological
10^6 plaque-forming units (PFU); administered as nose drops
RSV 6120/ΔNS2/1030s VaccineBiological
10^5 plaque-forming units (PFU); administered as nose drops
RSV 276 VaccineBiological
10^5 plaque-forming units (PFU); administered as nose drops
PlaceboBiological
Administered as nose drops

Study groups in NCT03916185
Study group	Role	What they receive
RSV ΔNS2/Δ1313/I1314L Vaccine	Experimental	Participants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0). Receives: Biological: RSV ΔNS2/Δ1313/I1314L Vaccine
RSV 6120/ΔNS2/1030s Vaccine	Experimental	Participants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0). Receives: Biological: RSV 6120/ΔNS2/1030s Vaccine
RSV 276 Vaccine	Experimental	Participants received a single dose of the RSV 276 vaccine at study entry (Day 0). Receives: Biological: RSV 276 Vaccine
Placebo	Placebo comparator	Participants received a single dose of placebo at study entry (Day 0). Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage With Grade 1 or Higher Solicited Adverse Events (AEs)
Solicited adverse events include fever, otitis media, upper respiratory illness (URI), and lower respiratory illness (LRI) and are graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. All solicited AEs with at least mild severity were included. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Measured: Day 0 through Day 28
Percentage With Grade 2 or Higher Lower Respiratory Illnesses (LRIs)
LRIs graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. All solicited LRIs with at least moderate severity were included. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Measured: Day 0 through Day 28
Percentage With Serious AEs
Serious adverse events are defined according to Version 2.0 of the DAIDS EAE Manual. A serious event is one that requires or lengthens hospitalization, that is life-threatening, that results in death, that results in a significant disability, or that is a congenital anomaly or birth defect. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Measured: Day 0 through Day 56
Percentage With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer
Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-study product administration and Day 56 time points. Percentage with 95% exact confidence intervals (CIs) using the Clopper-Pearson method were calculated. The upper limit of the CI was compared to an a priori limit of 70%. An upper limit above 70% was considered a good vaccine candidate.
Measured: Measured at pre-study product administration (screening) through Day 56

Secondary outcomes (7)

Percentage With a Greater Than or Equal to 4-fold Rise in Serum RSV F Immunoglobulin G (IgG)
RSV F IgG responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-study product administration and Day 56 time points. Percentage with 95% exact CIs using the Clopper-Pearson method were calculated. The upper limit of the CI was compared to an a priori level of 70%. An upper limit above 70% was considered a good vaccine candidate.
Measured: Measured at pre-study product administration (screening) and Day 56
Titer of Serum RSV F IgG
Serum F IgG antibodies were assessed by Enzyme-linked Immunosorbent Assay (ELISA). Titers below the limit of detection (1:50) were assigned a value equal to half the corresponding limit of detection (1:25) and evaluated as reciprocals of the titer (log2).
Measured: Measured at the Day 56 Visit
Titer of Serum RSV-neutralizing Antibodies
Serum RSV-neutralizing antibody titers were assessed by RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Titers below the limit of detection (1:10) were assigned a value equal to half the corresponding limit of detection (1:5) and evaluated as reciprocals of the titer (log2).
Measured: Measured at the Day 56 Visit
Percentage With RSV-associated Medically Attended Acute Respiratory Illness (RSV-MAARI)
The percentage and 95% exact Clopper-Pearson CI 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 wild type (wt) RSV during the RSV season surveillance period was defined as having either RSV detected in nasal samples collected during illness visits for MAARI events or through site reporting. RSV-associated upper respiratory tract illness, lower respiratory tract illness, otitis media, or fever were graded following a protocol-defined grading system.
Measured: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the study
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAARI
The number of participants who had RSV-MAARI among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance period was defined as having either RSV detected in nasal samples collected during illness visits for MAARI events or through site reporting. A participant was only counted once in the line corresponding to the highest grade MAARI event they experienced. These events were graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Measured: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the study
Percentage With RSV-associated Medically Attended Acute Lower Respiratory Illness (RSV-MAALRI)
The percentage and 95% exact Clopper-Pearson CI of participants who had RSV-associated, symptomatic, medically attended acute lower respiratory tract illness (MAALRI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance period was defined as having either RSV detected in nasal samples collected during illness visits for MAALRI events or through site reporting. RSV-associated lower respiratory tract illness graded following a protocol-defined grading system.
Measured: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the study
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAALRI
The number of participants who had RSV-MAALRI among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance period was defined as having either RSV detected in nasal samples collected during illness visits for MAALRI events or through site reporting. A participant was only counted once in the line corresponding to the highest grade MAALRI event they experienced. These events were graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Measured: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201925 Apr 2024

First posted16 Apr 2019
Study start20 Jun 2019
Primary completion22 Jan 2024
Study completion25 Apr 2024

Why it stopped: The study closed to enrollment prior to fully accruing due to difficulties with slower than expected accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory Syncytial Virus (RSV)Studies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03916185
Sponsor's protocol ID: IMPAACT 2021
Other IDs: 38530
Status last verified: Jan 2025
First submitted: 10 Apr 2019
Last updated: 21 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie results in the publication, after deidentification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age
ClinicalTrials.gov ID: NCT03916185
Acronym / sponsor ID: IMPAACT 2021
Conditions: Respiratory Syncytial Virus (RSV)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study closed to enrollment prior to fully accruing due to difficulties with slower than expected accrual.
Enrolment: 67 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 20 Jun 2019 (actual)
Primary completion: 22 Jan 2024 (actual)
Study completion: 25 Apr 2024 (actual)
First posted: 16 Apr 2019 (actual)
Results: Posted 21 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants were randomly assigned to receive a single dose of RSV ΔNS2/Δ1313/I1314L vaccine, RSV 6120/ΔNS2/1030s vaccine, RSV 276 vaccine, or placebo intranasally at study entry.

The study closed to enrollment prior to fully accruing due to difficulties with slower than expected accrual.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
RSV ΔNS2/Δ1313/I1314L Vaccine	Experimental	Biological: RSV ΔNS2/Δ1313/I1314L VaccineParticipants received a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
RSV 6120/ΔNS2/1030s Vaccine	Experimental	Biological: RSV 6120/ΔNS2/1030s VaccineParticipants received a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
RSV 276 Vaccine	Experimental	Biological: RSV 276 VaccineParticipants received a single dose of the RSV 276 vaccine at study entry (Day 0).
Placebo	Placebo comparator	Biological: PlaceboParticipants received a single dose of placebo at study entry (Day 0).

Who may qualify

Ages: 6 to 25 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease.
Parent/guardian is willing and able to provide written informed consent as described in the study protocol.
Seronegative for RSV antibody, defined as a serum RSV-neutralizing antibody titer less than 1:40 at screening from a sample collected no more than 42 days prior to study product administration.
Growing normally for age in the opinion of the site clinician in the six months prior to enrollment AND has a current height and weight above the 3rd percentile for age and sex per Centers for Disease Control and Prevention (CDC) World Health Organization (WHO) growth standards.
Has received routine immunizations appropriate for age (as per national Center for Disease Control Advisory Committee on Immunization Practices [ACIP]). Note: COVID-19 vaccination will not be required unless fully licensed for this age group and ACIP-recommended. See study-specific Manual of Procedures for further guidance

Key exclusion criteria (43 listed)

Prior laboratory-confirmed RSV infection.
Known or suspected HIV infection or impairment of immunological functions.
Receipt of immunosuppressive therapy, including any systemic, nasal, or inhaled corticosteroids within 28 days of enrollment. Note: Cutaneous (topical) steroid treatment is not an exclusion.
Any receipt of bone marrow/solid organ transplant.
Major congenital malformations (such as congenital cleft palate) or cytogenetic abnormalities.

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 Vaccine10^6 plaque-forming units (PFU); administered as nose drops	Biological	RSV ΔNS2/Δ1313/I1314L Vaccine
RSV 6120/ΔNS2/1030s Vaccine10^5 plaque-forming units (PFU); administered as nose drops	Biological	RSV 6120/ΔNS2/1030s Vaccine
RSV 276 Vaccine10^5 plaque-forming units (PFU); administered as nose drops	Biological	RSV 276 Vaccine
PlaceboAdministered as nose drops	Biological	Placebo

Primary outcome

Percentage With Grade 1 or Higher Solicited Adverse Events (AEs)
Time frame: Day 0 through Day 28
Solicited adverse events include fever, otitis media, upper respiratory illness (URI), and lower respiratory illness (LRI) and are graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. All solicited AEs with at least mild severity were included. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Percentage With Grade 2 or Higher Lower Respiratory Illnesses (LRIs)
Time frame: Day 0 through Day 28
LRIs graded following a protocol-defined grading system. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. All solicited LRIs with at least moderate severity were included. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Percentage With Serious AEs
Time frame: Day 0 through Day 56
Serious adverse events are defined according to Version 2.0 of the DAIDS EAE Manual. A serious event is one that requires or lengthens hospitalization, that is life-threatening, that results in death, that results in a significant disability, or that is a congenital anomaly or birth defect. Percentage with 95% exact confidence intervals using the Clopper-Pearson method were calculated.
Percentage With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer
Time frame: Measured at pre-study product administration (screening) through Day 56
Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-study product administration and Day 56 time points. Percentage with 95% exact confidence intervals (CIs) using the Clopper-Pearson method were calculated. The upper limit of the CI was compared to an a priori limit of 70%. An upper limit above 70% was considered a good vaccine candidate.

7 secondary outcomes

Percentage With a Greater Than or Equal to 4-fold Rise in Serum RSV F Immunoglobulin G (IgG)
Time frame: Measured at pre-study product administration (screening) and Day 56
Titer of Serum RSV F IgG
Time frame: Measured at the Day 56 Visit
Titer of Serum RSV-neutralizing Antibodies
Time frame: Measured at the Day 56 Visit
Percentage With RSV-associated Medically Attended Acute Respiratory Illness (RSV-MAARI)
Time frame: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the study
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAARI
Time frame: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the study
Percentage With RSV-associated Medically Attended Acute Lower Respiratory Illness (RSV-MAALRI)
Time frame: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the study
Maximum Grade (if More Than One Illness Within a Participant) of RSV-MAALRI
Time frame: Measured through the last day of the RSV season, which will occur between 5 and 15 months after study entry, depending on when the participant enrolls in the study

Results and safety

Results posted to the registry on 21 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RSV ΔNS2/Δ1313/I1314L Vaccine	20	18
RSV 6120/ΔNS2/1030s Vaccine	20	19
RSV 276 Vaccine	7	7
Placebo	20	19

Primary outcome: Percentage With Grade 1 or Higher Solicited Adverse Events (AEs)

Time frame: Day 0 through Day 28. Number (95% Confidence Interval). Unit: percentage of participants

Measure	RSV ΔNS2/Δ1313/I1314L Vaccine n = 20	RSV 6120/ΔNS2/1030s Vaccine n = 20	RSV 276 Vaccine n = 7	Placebo n = 20
Value	55 (32 to 77)	40 (19 to 64)	71 (29 to 96)	55 (32 to 77)

RSV ΔNS2/Δ1313/I1314L Vaccine vs Placebo: Difference in proportions: 0 (95% CI -32 to 32), p >0.99, Fisher Exact
RSV 6120/ΔNS2/1030s Vaccine vs Placebo: Difference in proportions: -15 (95% CI -46 to 18), p = 0.53, Fisher Exact
RSV 276 Vaccine vs Placebo: Difference in proportions: 16 (95% CI -29 to 52), p = 0.66, Fisher Exact

Population analysed: All participants who received study product

Primary outcome: Percentage With Grade 2 or Higher Lower Respiratory Illnesses (LRIs)

Time frame: Day 0 through Day 28. Number (95% Confidence Interval). Unit: percentage of participants

Measure	RSV ΔNS2/Δ1313/I1314L Vaccine n = 20	RSV 6120/ΔNS2/1030s Vaccine n = 20	RSV 276 Vaccine n = 7	Placebo n = 20
Value	5 (0 to 25)	0 (0 to 17)	0 (0 to 41)	5 (0 to 25)

RSV ΔNS2/Δ1313/I1314L Vaccine vs Placebo: Difference in proportions: 0 (95% CI -20 to 20), p >0.99, Fisher Exact
RSV 6120/ΔNS2/1030s Vaccine vs Placebo: Difference in proportions: -5 (95% CI -25 to 13), p >0.99, Fisher Exact
RSV 276 Vaccine vs Placebo: Difference in proportions: -5 (95% CI -26 to 34), p >0.99, Fisher Exact

Population analysed: All participants who received study product

Primary outcome: Percentage With Serious AEs

Time frame: Day 0 through Day 56. Number (95% Confidence Interval). Unit: percentage of participants

Measure	RSV ΔNS2/Δ1313/I1314L Vaccine n = 20	RSV 6120/ΔNS2/1030s Vaccine n = 20	RSV 276 Vaccine n = 7	Placebo n = 20
Value	0 (0 to 17)	0 (0 to 17)	0 (0 to 41)	0 (0 to 17)

RSV ΔNS2/Δ1313/I1314L Vaccine vs Placebo: Difference in proportions: 0 (95% CI -18 to 18), p >0.99, Fisher Exact
RSV 6120/ΔNS2/1030s Vaccine vs Placebo: Difference in proportions: 0 (95% CI -18 to 18), p >0.99, Fisher Exact
RSV 276 Vaccine vs Placebo: Difference in proportions: 0 (95% CI -17 to 41), p >0.99, Fisher Exact

Population analysed: All participants who received study product

Primary outcome: Percentage With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer

Time frame: Measured at pre-study product administration (screening) through Day 56. Number (95% Confidence Interval). Unit: percentage of participants

Measure	RSV ΔNS2/Δ1313/I1314L Vaccine n = 17	RSV 6120/ΔNS2/1030s Vaccine n = 17	RSV 276 Vaccine n = 7	Placebo n = 20
Value	76 (50 to 93)	71 (44 to 90)	71 (29 to 96)	15 (3 to 38)

RSV ΔNS2/Δ1313/I1314L Vaccine vs Placebo: Difference in proportions: 61 (95% CI 27 to 83), p <0.001, Fisher Exact
RSV 6120/ΔNS2/1030s Vaccine vs Placebo: Difference in proportions: 56 (95% CI 22 to 79), p <0.001, Fisher Exact
RSV 276 Vaccine vs Placebo: Difference in proportions: 56 (95% CI 9 to 86), p = 0.011, Fisher Exact

Population analysed: Participants with samples available at baseline and Day 56, with Day 56 Visit in the protocol-defined visit window, and one participant randomly selected from households with more than one child enrolled on the same date

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 to 12 months depending on when a participant enrolled and how close the enrollment was to the start of RSV season. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RSV ΔNS2/Δ1313/I1314L Vaccine	0 of 20 (0%)	14 of 20 (70%)	0 of 20
RSV 6120/ΔNS2/1030s Vaccine	0 of 20 (0%)	11 of 20 (55%)	0 of 20
RSV 276 Vaccine	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
Placebo	0 of 20 (0%)	13 of 20 (65%)	0 of 20

Limitations and caveats (from the sponsor): The study closed to enrollment prior to fully accruing. As a result, outcomes were estimated with less precision than originally planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1 July 2017Link provided by the sponsor.
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.

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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.

Coleen Cunningham, MD study chair

University of California, Irvine

Ruth Karron, MD study chair

Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 43 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: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage With Grade 1 or Higher Solicited Adverse Events (AEs) (time frame: Day 0 through Day 28). The study lists 4 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 NCT03916185.

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 21 Feb 2025.