This study is NOT currently recruiting participants.
Number
000410-I
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: 50 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Seasonal Influenza; Flu Virus; Respiratory Illness; Viral Infection; Experimental Vaccine; Nanoparticle Vaccine; Adjuvant
Recruitment Keyword(s)
None
Condition(s)
Influenza; seasonal influenza
Investigational Drug(s)
VRC-FLUMOS0111-00-VP VRC-GENADJ0110-AP-NV
Investigational Device(s)
Intervention(s)
Drug: VRC-FLUMOS0111-00-VP (FluMos-v1) Biological/Vaccine: Flucelvax Drug: VRC-GENADJ0110-AP-NV (Adjuplex)
Supporting Site
National Institute of Allergy and Infectious Diseases
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 years inclusive were enrolled.
Design:
Participants were screened through a separate protocol.
Participants were tested for COVID-19. They may have had a pregnancy test.
Participants received the investigational FluMos-v1 vaccine or the licensed inactivated seasonal quadrivalent influenza vaccine Flucelvax injected in the upper arm.
Participants completed a diary card for 7 days. They recorded any symptoms they had. They were given a thermometer to check their temperature. They were also given a ruler to measure any skin changes at the injection site.
Participants had about 10 study visits. They were asked how they were feeling and if they had taken any medications. They had blood drawn.
Some participants had an optional apheresis. Blood was removed through a needle in a vein in one arm. A machine separated the white blood cells. The rest of the blood was returned through a needle in a vein in the other arm.
Participation lasted for 40 weeks.
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INCLUSION CRITERIA: Participant must have met 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: 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 9. White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval 10. Total lymphocyte count >=800 cells/microliter 11. Platelets = 125,000 - 500,000 cells/microliter 12. Hemoglobin within institutional normal range or accompanied by the PI or designee approval 13. Alanine aminotransferase (ALT) <=1.25 x institutional upper limit of normal (ULN) 14. Aspartate aminotransferase (AST) <=1.25 x institutional ULN 15. Alkaline phosphatase (ALP) <1.1 x institutional ULN 16. Total bilirubin within institutional normal range or accompanied by the PI or designee approval. 17. Serum creatinine <=1.1 x institutional ULN 18. Negative for HIV infection by an FDA-approved method of detection 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: Participant was excluded if one or more of the following conditions applied: 1. Breast-feeding or planning to become pregnant during the study Participant 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: a. Groups 1A, 2A, and 3A only: Receipt of the 2020-2021 season's licensed influenza vaccine at any time prior to enrollment b. 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: a. Groups 4A and 5A only: Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine at any time prior to enrollment b. Groups 4B and 5B only: Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine within 4 months prior to enrollment. Participant had 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 participant's ability to give informed consent.
Participant must have met 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: 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
9. White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
10. Total lymphocyte count >=800 cells/microliter
11. Platelets = 125,000 - 500,000 cells/microliter
12. Hemoglobin within institutional normal range or accompanied by the PI or designee approval
13. Alanine aminotransferase (ALT) <=1.25 x institutional upper limit of normal (ULN)
14. Aspartate aminotransferase (AST) <=1.25 x institutional ULN
15. Alkaline phosphatase (ALP) <1.1 x institutional ULN
16. Total bilirubin within institutional normal range or accompanied by the PI or designee approval.
17. Serum creatinine <=1.1 x institutional ULN
18. Negative for HIV infection by an FDA-approved method of detection
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:
Participant was excluded if one or more of the following conditions applied:
1. Breast-feeding or planning to become pregnant during the study
Participant 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:
a. Groups 1A, 2A, and 3A only: Receipt of the 2020-2021 season's licensed influenza vaccine at any time prior to enrollment
b. 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:
a. Groups 4A and 5A only: Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine at any time prior to enrollment
b. Groups 4B and 5B only: Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine within 4 months prior to enrollment.
Participant had 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 participant's ability to give informed consent.
Principal Investigator
Referral Contact
For more information: