2017 A/H7N9 IIV Revaccination

Completed · Phase 2

Conditions studied: Avian Influenza, Influenza Immunisation

In brief

This is a Phase II clinical trial in up to 420 males and non-pregnant females, 19 to 70 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 one dose of a monovalent inactivated split influenza 2017 A/H7N9 virus vaccine (2017 A/H7N9 IIV), administered intramuscularly (IM) at 3.75 mcg hemagglutinin (HA) per dose, given with or without AS03 adjuvant to subjects primed with a monovalent inactivated split influenza 2013 A/H7N9 virus vaccine (2013 A/H7N9 IIV) in DMID Protocols 13-0032 and 13-0033, or to those who are A/H7 IIV-naïve. Phosphate buffered saline (PBS) diluent will be used to achieve the targeted dosage. The study will be conducted at 9 Vaccine and Treatment Evaluation Unit (VTEU) sites (including their subcontractors). Study duration is approximately 17 months with subject participation duration up to 13 months. The primary objectives are: 1) to assess the safety and reactogenicity of 2017 A/H7N9 IIV given with or without AS03 adjuvant following receipt of one dose of study vaccine; 2) to assess the serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody responses following receipt of the study vaccine.

Key facts

Study ID

NCT03738241

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

304

Starts

2018-12-18

Expected to finish

2020-06-19

Last updated by the study team

2021-07-30

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects eligible to participate in this trial must meet all of the following 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.
• Must agree to have residual specimens and samples/specimens collected during this trial specifically for the purpose of future research stored for future research use.
• Are males or non-pregnant females, 19 to 70 years of age, inclusive.
• Are in good health* *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site PI or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal and inhaled medications (except inhaled corticosteroids as outlined in the Subject Exclusion Criteria as well as herbals, vitamins and supplements are permitted.
• Oral temperature is less than 100.0 degrees Fahrenheit.
• Pulse is 47 to 100 beats per minute, inclusive.
• Systolic blood pressure is 85 to 150 mmHg, inclusive.
• Diastolic blood pressure is 55 to 95 mmHg, inclusive.
• Erythrocyte Sedimentation Rate (ESR) is less than 30 mm per hour.
• Women of childbearing potential** must use an acceptable contraception method*** from 30 days before study vaccination until 60 days after study vaccination.
• *Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal.
• **Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the study vaccination, barrier methods such as condoms or diaphragms/cervical cap with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
• Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
• Received 1 or 2 doses of 2013 A/H7N9 IIV with or without AS03 or MF59 adjuvant in DMID Protocols 13-0032 or 13-0033, or are A/H7 IIV-naïve.

You may not qualify if…

• Subjects eligible to participate in this trial must not meet any of the following exclusion criteria:
• Have an acute illness*, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
• An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation**.
• *Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
• Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
• Use of cytotoxic anticancer chemotherapy or radiation therapy within 3 years prior to study vaccination.
• Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
• Have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
• Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
• Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
• Have a personal or family history of narcolepsy.
• Have a history of Guillain-Barré Syndrome (GBS).
• Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
• Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).
• Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
• Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere*** with subject compliance or safety evaluations.
• **As determined by the site PI or appropriate sub-investigator.
• Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
• Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.
• Have taken high-dose inhaled corticosteroids**** within 30 days prior to study vaccination.
• ***High-dose defined as per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE.
• Received or plan to receive a licensed, live vaccine within 30 days before or after study vaccination.
• Received or plan to receive a licensed, inactivated vaccine (excluding all licensed, seasonal IIVs) within 14 days before or after study vaccination.
• Received or plan to receive a licensed, seasonal IIV within 21 days before or after study vaccination.

Where it is running

• Emory Children's Center - Pediatric Infectious Diseases — Atlanta, Georgia, United States
• University of Iowa - Vaccine Research and Education Unit — Iowa City, Iowa, United States
• University of Maryland Baltimore - School of Medicine - Medicine — Baltimore, Maryland, United States
• Saint Louis University - Center for Vaccine Development — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center - Infectious Diseases — Cincinnati, Ohio, United States
• Vanderbilt University Medical Center - Infectious Diseases — Nashville, Tennessee, United States
• The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD) — Galveston, Texas, United States
• Baylor College of Medicine - Molecular Virology and Microbiology — Houston, Texas, United States
• Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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