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Respiratory Syncytial Virus InfectionsPhase 1NCT02952339

Evaluating the Infectivity, Safety, and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants and Children 6 to 24 Months of Age

A Phase 1 study testing RSV LID ΔM2-2 1030s vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study is a companion study to IMPAACT 2011. Read more about this study

Who is it for?
Ages 6 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSV LID ΔM2-2 1030s vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
2 sitesUnited States
Study dates
Aug 2016to Jul 2017
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 6 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Greater than or equal to 6 months (greater than or equal to 180 days) of age at the time of screening and less than 25 months (less than 750 days) of age
  • Participant is in good health based on review of the medical record, history, and physical examination, without evidence of chronic disease
  • Parents/guardians are willing and able to provide written informed consent
  • 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 inoculation
  • Is growing at a normal velocity 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
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  • If 1 year of age or older: has a current height and weight above the 3rd percentile for age
  • Participant has received routine immunizations appropriate for age (as per Center for Disease Control Advisory Committee on Immunization Practices [ACIP])
  • Participant is expected to be available for the duration of the study

Who cannot join

  • Known or suspected HIV infection or impairment of immunological functions
  • Receipt of immunosuppressive therapy, including any systemic, including either nasal or inhaled, corticosteroids within 28 days of enrollment. Note: Cutaneous (topical) steroid treatment is not an exclusion.
  • Bone marrow/solid organ transplant recipient
  • Major congenital malformations (such as congenital cleft palate) or cytogenetic abnormalities
  • Previous receipt of a licensed or investigational RSV vaccine or receipt of placebo in this study or previous receipt of or planned administration of any anti-RSV product (such as ribavirin or RSV IG)
  • Previous anaphylactic reaction
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  • Previous vaccine-associated adverse reaction that was Grade 3 or above
  • Known hypersensitivity to any study product component
  • Heart disease. Note: 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 documented wheezing
  • Member of a household that contains, or will contain, an infant who is less than 6 months of age at the enrollment date through Day 28
  • Member of a household that contains another child who is, or is scheduled to be, enrolled in CIR 311, 312 or 313 AND there has been or will be an overlap in residency during that other child's participation in the study's Acute Phase (Days 0 to 28)
  • Member of a household that 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
  • Attends a daycare facility and shares a room with infants less than 6 months of age, and parent/guardian is unable or unwilling to suspend daycare for 28 days following inoculation
  • 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 (rhinorrhea, cough, or pharyngitis) or
  • nasal congestion significant enough to interfere with successful inoculation, or
  • otitis media
  • Receipt of the following prior to enrollment:
  • any killed 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
  • Scheduled administration of the following after planned inoculation:
  • killed 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 immunoglobulin, any antibody products, or any blood products within the past 6 months
  • 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 medication except as listed below
  • Receipt of salicylate (aspirin) or salicylate-containing products within the past 28 days
  • Born at less than 34 weeks gestation
  • Born at less than 37 weeks gestation and less than 1 year of age at the time of enrollment
  • Meets criteria for failure to thrive within the six months prior to enrollment: a decline in height or weight growth that has crossed two major growth percentiles (e.g., from above the 75th to below the 25th) in an interval of less than 6 months
  • Suspected or documented developmental disorder, delay, or other developmental problem
  • Previous receipt of supplemental oxygen therapy in a home setting

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Center for Immunization Research

    Baltimore, Maryland, 21205

  • Center for Immunization Research South

    Laurel, Maryland, 20708

Other trials in United States

About this study

Official title: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-attenuated Respiratory Syncytial Virus Vaccine, LID ΔM2-2 1030s, Lot RSV#010A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age.

This study is a companion study to IMPAACT 2011.

Read the detailed description

Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age worldwide. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated RSV vaccine, RSV LID ΔM2-2 1030s, in RSV-seronegative infants 6 to 24 months of age.

Participants will be randomly assigned to receive a single dose of the RSV LID ΔM2-2 1030s vaccine or placebo (administered as nose drops) at study entry (Day 0).

Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season, and will remain on study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Total study duration is between 6 to 13 months, depending on when participants enroll in the study. Participants will attend several study visits throughout the study, and the visits may include blood collection, nasal washes, and physical examinations. Participants' parents or guardians will be contacted by study staff at various times during the study to monitor participants' health.

Being tested
RSV LID ΔM2-2 1030s vaccine, Placebo
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 LID ΔM2-2 1030s vaccineBiological

    10^5.0 PFU; administered as nose drops

  • PlaceboBiological

    Administered as nose drops

Study groups in NCT02952339
Study groupRoleWhat they receive
RSV LID ΔM2-2 1030s vaccineExperimentalParticipants will receive a single dose of the RSV LID ΔM2-2 1030s vaccine at Day 0.
Receives: Biological: RSV LID ΔM2-2 1030s vaccine
PlaceboPlacebo comparatorParticipants will receive a single dose of placebo vaccine at Day 0.
Receives: Biological: Placebo

What is being measured

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

  1. Grades of study product-related solicited adverse events (AEs) as defined in the protocol

    Measured: Measured through Day 28

  2. Grades of study product-related unsolicited AEs

    Measured: Measured through Day 28

  3. Grades of study product-related serious adverse events (SAEs)

    Measured: Measured through Day 56

  4. Number of participants with infection with vaccine virus

    Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes done throughout the study period; Day 0 nasal wash will be counted as baseline) or 2) greater than or equal to 4-fold rise in RSV neutralizing antibody titer from Study Day 0-56

    Measured: Measured through Day 56

  5. Peak titer of vaccine virus shed

    Measured: Measured through Day 28

  6. Duration of vaccine virus shedding in nasal washes measured by culture

    Measured: Measured through Day 28

  7. Duration of vaccine virus shedding in nasal washes measured by RT-PCR

    Measured: Measured through Day 28

  8. Greater than or equal to 4-fold rise in RSV-neutralizing antibody titer

    Measured: Measured through Day 56

  9. Antibody responses to RSV F glycoprotein as assessed by ELISA

    Measured: Measured through Day 56

Secondary outcomes (3)

  1. Frequency of symptomatic, medically attended respiratory and febrile illness in the vaccine and placebo recipients who experience natural infection with wt RSV during the subsequent RSV season

    Will be measured through the subsequent RSV season (November 1 in the calendar year of study entry to March 31 in the calendar year following study entry)

    Measured: Measured through 5 months

  2. Measurement of antibody responses in the vaccine and placebo recipients who experience natural infection with wt RSV during the subsequent RSV season

    Will be measured at the post-RSV season visit (between April 1 and April 30 in the calendar year following study entry)

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

  3. Changes from baseline in the B cell responses to RSV

    Will be measured at the post-RSV season visit (between April 1 and April 30 in the calendar year following study entry)

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

Timeline

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

  1. First posted2 Nov 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952339
Sponsor's protocol ID
CIR 311
Status last verified
Feb 2018
First submitted
31 Oct 2016
Last updated
13 Feb 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RSV LID ΔM2-2 1030s 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 9 inclusion and 42 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 Feb 2018. 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?

Grades of study product-related solicited adverse events (AEs) as defined in the protocol (time frame: Measured through Day 28). The study lists 9 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 NCT02952339.

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 Feb 2018.

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