National Institute of Allergy and Infectious Diseases (NIAID)
Phase 1
2019-06-10
This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and
non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all
eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity
and immunogenicity of either the 2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza
Vaccine (QIV) manufactured by Sanofi Pasteur (SP) given without adjuvant or with one of two
adjuvant formulations, AF03 or Advax-CpG55.2. Eight Vaccine and Treatment Evaluation Unit
(VTEU) sites will be included in the study. Study duration is approximately 18 months, and
subject participation duration is 12 months. The primary objectives of this study are: 1) to
assess the safety and reactogenicity of 2018/2019 Fluzone and Flublok with and without AF03
or Advax-CpG55.2 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) antibody
responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after
receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 3)
to assess the serum neuraminidase inhibition antibody (NAI) responses by enzyme-linked lectin
assay (ELLA) against NA antigens in the 2018/2019 QIV from baseline (Day 1) to approximately
Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2
adjuvant; 4) to assess the influenza neutralizing (Neut) antibody titer responses against
2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of
2018/2019 Fluzone and Flublok with and without AF03 or Advax- CpG55.2 adjuvant.
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