A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant Fusion (F) Nanoparticle Vaccine, With or Without Aluminum Adjuvant, in Healthy Subjects 24 to <72 Months of Age

NCT02296463 Phase 1 COMPLETED

This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and female subjects ≥24 months of age and \<72 months of age. Subjects will be without symptomatic chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be screened for seropositivity to RSV in a qualified serum microneutralization (MN) assay and will be excluded if titers for either RSV/A or RSV/B are \<1:16 (4 log2). Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and in one group placebo) will be used to maintain the study blind; all subjects will receive a complete course of hepatitis A vaccine as a study benefit.

Details

Lead sponsor	Novavax
Phase	Phase 1
Status	COMPLETED
Enrolment	32
Start date	2014-11
Completion	2016-04

Conditions

• Respiratory Synctial Virus

Interventions

• RSV F Vaccine with adjuvant (0.5mL injection)
• RSV F Vaccine (0.5mL injection)
• Hepatitis A Vaccine (0.5mL injection)
• Placebo (0.5mL injection)

Primary outcomes

• Numbers and percentages of subjects with solicited local and systemic AEs. — Up to Day 392
  Solicited local and systemic AEs over the 7 days post injection; and all AES, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 56 days post- first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
• Immunogenicity as assessed by serum IgG antibody levels specific for the F protein antigen as detected by enzyme-linked immunosorbent assay (ELISA) providing a standardized ELISA Unit (EU) reasout based on a standard reference sample. — Up to Day 392
  Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroresponse rate (SRR)

Countries

Canada