NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

VRC 325 (000410): A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability and Immunogenicity of Mosaic Quadrivalent Influenza Vaccine with and without Adjuplex Compared with a Licensed Inactivated Seasonal QIV, In Healthy Adults

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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)

None

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

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 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.

--Back to Top--

Eligibility

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.


--Back to Top--

Citations:

Lambert LC, Fauci AS. Influenza vaccines for the future. N Engl J Med. 2010 Nov 18;363(21):2036-44. doi: 10.1056/NEJMra1002842. PMID: 21083388.

Kanekiyo M, Joyce MG, Gillespie RA, Gallagher JR, Andrews SF, Yassine HM, Wheatley AK, Fisher BE, Ambrozak DR, Creanga A, Leung K, Yang ES, Boyoglu-Barnum S, Georgiev IS, Tsybovsky Y, Prabhakaran MS, Andersen H, Kong WP, Baxa U, Zephir KL, Ledgerwood JE, Koup RA, Kwong PD, Harris AK, McDermott AB, Mascola JR, Graham BS. Mosaic nanoparticle display of diverse influenza virus hemagglutinins elicits broad B cell responses. Nat Immunol. 2019 Mar;20(3):362-372. doi: 10.1038/s41590-018-0305-x. Epub 2019 Feb 11. Erratum in: Nat Immunol. 2019 Apr 12;: PMID: 30742080; PMCID: PMC6380945.

Boyoglu-Barnum S, Ellis D, Gillespie RA, Hutchinson GB, Park YJ, Moin SM, Acton OJ, Ravichandran R, Murphy M, Pettie D, Matheson N, Carter L, Creanga A, Watson MJ, Kephart S, Ataca S, Vaile JR, Ueda G, Crank MC, Stewart L, Lee KK, Guttman M, Baker D, Mascola JR, Veesler D, Graham BS, King NP, Kanekiyo M. Quadrivalent influenza nanoparticle vaccines induce broad protection. Nature. 2021 Apr;592(7855):623-628. doi: 10.1038/s41586-021-03365-x. Epub 2021 Mar 24. PMID: 33762730; PMCID: PMC8269962.

Yang RS, Traver M, Barefoot N, Stephens T, Alabanza C, Manzella-Lapeira J, Zou G, Wolff J, Li Y, Resto M, Shadrick W, Yang Y, Ivleva VB, Tsybovsky Y, Carlton K, Brzostowski J, Gall JG, Lei QP. Mosaic quadrivalent influenza vaccine single nanoparticle characterization. Sci Rep. 2024 Feb 24;14(1):4534. doi: 10.1038/s41598-024-54876-2. PMID: 38402303; PMCID: PMC10894272.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Lesia K. Dropulic, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)



Floreliz H. Mendoza
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 5-2452
10 Center Drive
Bethesda, Maryland 20892
(301) 451-8715
mendozaf@mail.nih.gov

VRC Clinic
National Institute of Allergy and Infectious Diseases (NIAID)
Vaccine Research Center
National Institutes of Health (NIH)
Bethesda, MD 20892

(301) 451-8715
vaccines@nih.gov

Clinical Trials Number:

NCT04896086

--Back to Top--