Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    105
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 11 September 2021
antibody titer
respiratory syncytial virus vaccines

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 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.

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.

Details
Condition rsv infection, Respiratory syncytial virus infection
Treatment Placebo, RSV ΔNS2 Δ1313 I1314L Vaccine
Clinical Study IdentifierNCT01893554
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 100.4F [38C]), 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
Inclusion Criteria for Second Year of RSV Surveillance
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
Exclusion Criteria for Second Year of RSV Surveillance
Currently enrolled in another RSV study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note