TIV and High Dose TIV in Subjects With Rheumatoid Arthritis
Condition: Influenza
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving
      TNF-alpha-inhibitor therapy aged 18 to 64 years of age and healthy gender-and age-matched
      control subjects . This study will investigate the immunogenicity, safety, and reactogenicity
      of two different doses of inactivated trivalent influenza virus vaccine (Sanofi Pasteur
      Fluzone [15 mcg x 3 strains] and Sanofi Pasteur Fluzone High Dose [60 mcg x 3 strains])
      administered intramuscularly in individuals with rheumatoid arthritis receiving
      anti-TNF-alpha (TNFi) therapy and healthy age- and gender- matched controls.
    

Detailed description: 
      This is a randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis
      receiving TNF-alpha inhibitor therapy, aged 18 years to 64 years of age. This study is
      designed to investigate the immunogenicity, safety, and reactogenicity of two different doses
      of inactivated trivalent influenza virus vaccine given at two dose levels (15 mcg and 60 mcg)
      administered IM in individuals with rheumatoid arthritis receiving anti-TNF-alpha therapy or
      age and gender matched control subjects. The study is conducted over two seasons, 2011-2012
      and 2012-2013. Subjects enrolling between October 2011 and February 2012 will receive the
      2011-2012 vaccine, while those enrolling after July 2012 will receive the 2012-2013 vaccine.
      Immunogenicity testing will determine the proportion of subjects in each group with titer a
      4-fold rise in HAI titers (defined as either a pre-vaccination HAI titer <1:10 and a
      post-vaccination HAI titer >/=1:40 or a pre-vaccination HAI titer >/=1:10 and a minimum
      four-fold rise in post-vaccination HAI titer) against each of the specific influenza strains
      included in vaccine the subject received at day 21 following vaccination. The proportion of
      subjects in each group achieving a serum HAI titer of >/= 1:40 or a 4-fold rise in HAI titer
      or greater in HAI titer against each strain in the vaccine compared to the controls subjects.
      Safety testing will assess the occurrence of vaccine-associated Serious adverse events (SAEs)
      throughout the course of the study, and the occurrence of solicited local and systemic
      adverse events (AEs) within 8 days post vaccination. Solicited AEs (including rheumatoid
      arthritis clinical status) will be assessed during the course of the study. Subjects will
      have four face to face visits and one telephone contact. Day 0 will include the consent
      process, a medical history and physical exam for the RA subjects to assess the activity of
      their RA at the time of enrollment, vital signs, phlebotomy for prevaccine serology. Subjects
      will be randomized to receive IM seasonal TIV or High-Dose TIV at this visit and will receive
      the assigned vaccine. They will be observed for 20 minutes and will be taught to fill out a 7
      day memory aid that will assess daily temperature, local and systemic reactogenicity. A
      telephone call will be made to assess reactogenicity and to review the memory aid on day 3.
      Subjects will return on day 7 for review of the memory aid, AEs/SAEs, vital signs and
      phlebotomy for serology. A physical exam will be performed if indicated. They will return on
      day 21 and at 6 months for review of AEs/SAEs, vital signs and phlebotomy for serology. A
      physical exam will be performed if indicated.
    

Intervention name(s): Trivalent inactivated influenza vaccine; Trivalent inactivated influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone® High Dose [60 mcg x 3 strains]), as a single intramuscular dose. 80 and up to 100 subjects. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine and subjects enrolling after July 2012 will receive the 2012-2013 vaccine.; Inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone® [15 mcg x 3 strains]), as a single intramuscular dose. 80 and up to 100 subjects. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine and subjects enrolling after July 2012 will receive the 2012-2013 vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: influenza, rheumatoid arthritis, TNF-alpha-inhibitor, Fluzone®, Fluzone® High Dose