First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Background:

Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and sometimes the lungs. Vaccines are given to teach the body to prevent or fight infection. Researchers want to study a new vaccine to prevent the seasonal flu.

Objective:

To see if the FluMos-v1 vaccine is safe and how the body responds to it.

Eligibility:

Healthy adults ages 18-50 who received at least one licensed flu vaccine from 2016 through the 2019-2020 influenza season.

Design:

Participants will be screened through a separate protocol.

Participants will be tested for COVID-19. They may have a pregnancy test.

Participants will receive the FluMos-v1 vaccine or the Flucelvax vaccine. It will be injected in the upper arm.

Participants will complete a diary card for 7 days. They will record any symptoms they have. They will be given a thermometer to check their temperature. They will also be given a ruler to measure any skin changes at the injection site.

Participants will have about 10 study visits. They will be asked how they are feeling and if they have taken any medications. They will have blood drawn.

Participants will have oral mucosal samples collected using a thin swab. They may have nose and throat secretions collected using a thin swab.

Some participants will have optional apheresis. Blood will be removed through a needle in a vein in one arm. A machine will separate the white blood cells. The rest of the blood will be returned through a needle in a vein in the other arm.

Participation will last for 40 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

• INCLUSION CRITERIA:

A subject must meet all of the following criteria:

1. Healthy adults between the ages of 18-50 years inclusive

2. Based on history and physical examination, in good general health and without history of any of the conditions listed in the exclusion criteria

3. Part A: Received at least one licensed influenza vaccine from 2016 through the 2019-2020 influenza season

4. Part B and C: Received at least one licensed influenza vaccine from 2017 through the 2022-2023 influenza season

5. Able and willing to complete the informed consent process

6. Available for clinic visits for 40 weeks after enrollment and through an influenza season

7. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process

8. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) <=35 within the 56 days before enrollment

Laboratory Criteria within 56 days before enrollment

8. White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval

9. Total lymphocyte count >=800 cells/microliter

10. Platelets = 125,000 - 500,000 cells/microliter

11. Hemoglobin within institutional normal range or accompanied by the PI or designee approval

12. Alanine aminotransferase (ALT) <=1.25 x institutional upper limit of normal (ULN)

13. Aspartate aminotransferase (AST) <=1.25 x institutional ULN

14. Alkaline phosphatase (ALP) <1.1 x institutional ULN

15. Total bilirubin within institutional normal range or accompanied by the PI or designee approval.

16. Serum creatinine <=1.1 x institutional ULN

17. Negative for HIV infection by an FDA-approved method of detection

18. Negative for SARS-CoV-2 prior to enrollment

Criteria applicable to women of childbearing potential:

19. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment

20. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study

EXCLUSION CRITERIA:

A subject will be excluded if one or more of the following conditions apply:

1. Breast-feeding or planning to become pregnant during the study

Subject has received any of the following substances:

2. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment

3. Blood products within 16 weeks prior to enrollment

4. Live attenuated vaccines within 4 weeks prior to enrollment

5. Inactivated vaccines within 2 weeks prior to enrollment

6. Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study

7. Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule

8. Current anti-TB prophylaxis or therapy

9. Previous investigational H1, H2, or H10 influenza vaccines, including Part A participants

10. Part A:

1. Groups 1A, 2A, and 3A only: Receipt of the 2020-2021 season s licensed influenza vaccine at any time prior to enrollment

2. Groups 1B, 2B, and 3B only: Receipt of the 2020-2021 season s licensed influenza vaccine within 4 months prior to enrollment.

11. Part B and C:

1. Groups 4A, 5A, 6A, 7A, and 8A only: Receipt of the 2021-2022 or 2022-2023 season s licensed influenza vaccine at any time prior to enrollment

2. Groups 4B, 5B, 6B, 7B, and 8B only: Receipt of the 2021-2022 or 2022-2023 season s licensed influenza vaccine within 4 months prior to enrollment.

Subject has a history of any of the following clinically significant conditions:

12. Serious reactions to vaccines that preclude receipt of the study vaccination as determined by the investigator

13. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema

14. Asthma that is not well controlled

15. Diabetes mellitus (type I or II), with the exception of gestational diabetes

16. Thyroid disease that is not well controlled

17. Idiopathic urticaria within the past year

18. Autoimmune disease or immunodeficiency

19. Hypertension that is not well controlled

20. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws

21. Malignancy that is active or history of malignancy that is likely to recur during the period of the study

22. Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years

23. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen

24. Guillain-Barre Syndrome

25. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent.