CompletedPhase 1

Flublok or Fluzone With Advax-CpG55.2 or AF03

United States241 participantsStarted 2019-06-10

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide written informed consent prior to initiation of any study procedures.
✓. Are able to understand and comply with planned study procedures and be available for all study visits.
✓. Must agree to the collection of venous blood per protocol.
✓. Are males or non-pregnant females, 18 to 45 years of age, inclusive at time of enrollment.

Exclusion criteria

✕. Oral temperature is less than 100.0 degrees Fahrenheit.
✕. Pulse is 47 to 100 beats per minute, inclusive.
✕. Systolic blood pressure is 85 to 140 mmHg, inclusive.
✕. Diastolic blood pressure is 55 to 90 mmHg, inclusive.
✕0. Screening laboratories (Erythrocyte Sedimentation Rate (ESR), White Blood Cells (WBC), Hemoglobin (Hgb), Platelets (PLTs), Alanine Aminotransferase (ALT), Total Bilirubin (T. Bili), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Alkaline Phosphatase (ALP) serum lipase, serum amylase and Creatinine (Cr)) are within acceptable parameters\*.

What they're measuring

Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination

Timeframe: Day 1 through Day 8

Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29

Timeframe: Day 1 through Day 29

Number of Participants Reporting Serious Adverse Events (SAEs)

Timeframe: Day 1 through Day 365

Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination

Timeframe: Day 1 through Day 8

Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Timeframe: Day 1, Day 29

Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Timeframe: Day 1, Day 29

Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Timeframe: Day 29

Trial details

NCT IDNCT03945825

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-09-18

Results submitted2021-09-09

View on ClinicalTrials.gov More Influenza trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide written informed consent prior to initiation of any study procedures.
✓. Are able to understand and comply with planned study procedures and be available for all study visits.
✓. Must agree to the collection of venous blood per protocol.
✓. Are males or non-pregnant females, 18 to 45 years of age, inclusive at time of enrollment.

Exclusion criteria

✕. Oral temperature is less than 100.0 degrees Fahrenheit.
✕. Pulse is 47 to 100 beats per minute, inclusive.
✕. Systolic blood pressure is 85 to 140 mmHg, inclusive.
✕. Diastolic blood pressure is 55 to 90 mmHg, inclusive.
✕0. Screening laboratories (Erythrocyte Sedimentation Rate (ESR), White Blood Cells (WBC), Hemoglobin (Hgb), Platelets (PLTs), Alanine Aminotransferase (ALT), Total Bilirubin (T. Bili), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Alkaline Phosphatase (ALP) serum lipase, serum amylase and Creatinine (Cr)) are within acceptable parameters\*.

What they're measuring

Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination

Timeframe: Day 1 through Day 8

Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29

Timeframe: Day 1 through Day 29

Number of Participants Reporting Serious Adverse Events (SAEs)

Timeframe: Day 1 through Day 365

Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination

Timeframe: Day 1 through Day 8

Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Timeframe: Day 1, Day 29

Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Timeframe: Day 1, Day 29

Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Timeframe: Day 29