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About
The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age.
This study was a companion study to Center for Immunization Research (CIR) 321.
Full 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. This study evaluated the infectivity, safety, and immunogenicity of two recombinant live-attenuated RSV vaccines: RSV ΔNS2/Δ1313/I1314L and RSV 276. The vaccines were delivered as nose drops to RSV-seronegative infants 6 to 24 months of age.
Participants were randomly assigned to receive a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine, the RSV 276 vaccine, or placebo at study entry (Day 0).
Participants could be enrolled in the study outside of RSV season, i.e., between April 1 and October 14 for most sites or-for sites with local RSV seasons that start earlier-as specified on a site-by-site basis in the manual of procedures. Participants remained on study until they completed the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants' total study duration was between 6 and 13 months, depending on when they enrolled in the study. Participants attended several study visits throughout the study, which included physical examinations, blood collection, nasal washes, and/or nasal adsorption (nasosorption) specimen collection. Participants' parents or guardians were contacted by study staff at various times during the study to monitor participants' health.
Enrollment
Sex
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Volunteers
Inclusion criteria
In good health based on review of the medical record, history, and physical examination, without evidence of chronic disease.
Parent/guardian willing and able to provide written informed consent as described in the 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 inoculation.
Growing normally for age (i.e., not downwardly crossing two major centiles on a standard growth chart) in the six months prior to enrollment AND
Received routine immunizations appropriate for age (as per national Center for Disease Control Advisory Committee on Immunization Practices).
Expected to be available for the duration of the study.
If born to an HIV-infected woman, participant must not have been breastfed and 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.
Exclusion criteria
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.
Any receipt of bone marrow/solid organ transplant.
Major congenital malformations (such as congenital cleft palate) or cytogenetic abnormalities.
Previous receipt of a licensed or investigational RSV vaccine (or placebo in any International Maternal Pediatric Adolescent AIDS Clinical Trials Network RSV study) or previous receipt of or planned administration of any anti-RSV product (such as ribavirin or RSV IG or RSV mAb).
Any previous anaphylactic reaction.
Any previous vaccine-associated adverse reaction that was Grade 3 or above. Note: if grading is not possible, determine if the reaction was considered severe or life threatening; if so, it is exclusionary.
Any 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 diagnosed wheezing.
Member of a household that contained, or would contain, an infant who is less than 6 months of age at the enrollment date through Day 28.
Member of a household that contained another child/other children who was/were, or was/were scheduled to be, enrolled in IMPAACT 2018 AND the date of enrollment to IMPAACT 2018 would not be concurrent with the other participant(s) living in the household (i.e., all eligible children from the same household must be enrolled on the same date).
Member of a household that contained another child who was, or was scheduled to be, enrolled in another study evaluating an intranasal live-attenuated RSV vaccine, AND there has been or would 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 contained an immunocompromised individual, including, but not limited to:
Attended a daycare facility and shared a room with infants less than 6 months of age, and parent/guardian was unable or unwilling to suspend daycare for 28 days following inoculation.
Any of the following events at the time of enrollment:
Receipt of the following prior to enrollment:
Scheduled administration of the following after planned inoculation:
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:
Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days prior to enrollment.
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.
Current suspected or documented developmental disorder, delay, or other developmental problem.
Any previous receipt of supplemental oxygen therapy in a home setting.
Primary purpose
Allocation
Interventional model
Masking
65 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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