A Safety and Immunogenicity Study of Intranasal Sendai Virus Vectored Respiratory Syncytial Virus (SeVRSV) Vaccine in Healthy Adults
Condition: Antiviral Prophylaxis; Respiratory Syncytial Virus Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I randomized, double blind, placebo controlled trial in up to 25 males and
      non-pregnant females, 18-45 years old, inclusive, who are in good health and meet all
      eligibility criteria. This trial is designed to assess the safety, reactogenicity and
      immunogenicity of a single intranasal dose of Sendai virus vectored Respiratory Syncytial
      Virus (SeVRSV) vaccine. The subjects will be randomized in a 4:1 ratio to receive SeVRSV
      vaccine at a dose of 1 x 10^7 EID50 or placebo (saline) intranasally. Study duration is
      approximately 11 months with subject participation duration approximately 6 months. The
      primary objectives are to: 1) assess the safety and reactogenicity of SeVRSV vaccine
      following receipt of one intranasal dose; 2) assess the ELISA antibody responses to SeV and
      to the RSV F protein at 28 days post receipt of one intranasal dose of SeVRSV vaccine; 3)
      assess the detection of vaccine virus from nasal washes at days 3, 5, 8 and 15 following
      receipt of one intranasal dose of SeVRSV vaccine.
    

Detailed description: 
      This is a Phase I randomized, double blind, placebo controlled trial in up to 25 males and
      non-pregnant females, 18-45 years old, inclusive, who are in good health and meet all
      eligibility criteria. This trial is designed to assess the safety, reactogenicity and
      immunogenicity of a single intranasal dose of Sendai virus vectored Respiratory Syncytial
      Virus (SeVRSV) vaccine. The subjects will be randomly assigned in a 4:1 ratio to receive
      SeVRSV vaccine at a dose of 1 x 10^7 EID50 or placebo (saline) intranasally. Since this is a
      first in human, phase I study, the first two subjects (sentinels) will be enrolled in the
      SeVRSV treatment arm. Safety and laboratory data will be collected through 14 days post
      vaccination. If none of the predefined halting criteria of sentinel subjects are met,
      enrollment of the remaining subjects will proceed. If any of the pre-defined halting criteria
      of sentinel subjects are met, an electronic review by the SMC will be required prior to
      continuation of the study. While safety is evaluated for the sentinel subjects, no new
      subjects will be enrolled, but screening may continue. Study duration is approximately 11
      months with subject participation duration approximately 6 months. The primary objectives are
      to: 1) assess the safety and reactogenicity of SeVRSV vaccine following receipt of one
      intranasal dose; 2) assess the ELISA antibody responses to SeV and to the RSV F protein at 28
      days post receipt of one intranasal dose of SeVRSV vaccine; 3) assess the detection of
      vaccine virus from nasal washes at days 3, 5, 8 and 15 following receipt of one intranasal
      dose of SeVRSV vaccine.
    

Intervention name(s): Placebo; SeVRSV Vaccine
Intervention type(s): Other; Biological
Intervention description(s): 0.9% Sodium Chloride; Recombinant Sendai virus vectored respiratory syncytial virus (SeVRSV) vaccine. SeVRSV is a replication-competent Sendai virus that carries the RSV F gene produced by reverse genetics technology.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Immunogenicity; Respiratory Syncytial Virus; Safety; Sendai Virus; Vaccine