First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04896086 |
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Recruitment Status :
Recruiting
First Posted : May 21, 2021
Last Update Posted : March 28, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Influenza Seasonal Influenza | Other: VRC-GENADJ0110-AP-NV Biological: Flucelvax Drug: VRC-FLUMOS0111-00-VP (FluMos-v1) | Phase 1 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | 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 |
| Actual Study Start Date : | May 24, 2021 |
| Estimated Primary Completion Date : | May 1, 2023 |
| Estimated Study Completion Date : | May 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1A-1B
20 mcg of FluMos-v1
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Drug: VRC-FLUMOS0111-00-VP (FluMos-v1)
The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013) |
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Experimental: Group 2A-2B
60 mcg of FluMos-v1
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Drug: VRC-FLUMOS0111-00-VP (FluMos-v1)
The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013) |
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Active Comparator: Group 3A-3B
standard dose of 60 mcg of the licensed QIV Flucelvax
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Biological: Flucelvax
Flucelvax is a cell-based vaccine which contains the same four influenza strains selected by the WHO, and has shown better safety and immunogenicity profiles than the traditional licensed seasonal egg based vaccine. |
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Experimental: Group 4A-4B
100 mcg of FluMos-v1
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Drug: VRC-FLUMOS0111-00-VP (FluMos-v1)
The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013) |
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Experimental: Group 5A-5B
100 mcg of FluMos-v1 plus Adjuplex
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Other: VRC-GENADJ0110-AP-NV
Adjuplex is an adjuvant, a sterile, pyrogen-free adjuvant solution produced by VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline at a pH of 6.5 plus or minus 0.3. Adjuplex adjuvant will be mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B, 6A-6B, and 8A-8B. Drug: VRC-FLUMOS0111-00-VP (FluMos-v1) The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013) |
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Experimental: Group 6A-6B
Optional: 60 mcg of FluMos-v1 plus Adjuplex
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Other: VRC-GENADJ0110-AP-NV
Adjuplex is an adjuvant, a sterile, pyrogen-free adjuvant solution produced by VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline at a pH of 6.5 plus or minus 0.3. Adjuplex adjuvant will be mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B, 6A-6B, and 8A-8B. Drug: VRC-FLUMOS0111-00-VP (FluMos-v1) The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013) |
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Experimental: Group 7A-7B
Optional: TBD mcg of FluMos-v1
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Drug: VRC-FLUMOS0111-00-VP (FluMos-v1)
The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013) |
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Experimental: Group 8A-8B
Optional: TBD of FluMos-v1 plus Adjuplex
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Other: VRC-GENADJ0110-AP-NV
Adjuplex is an adjuvant, a sterile, pyrogen-free adjuvant solution produced by VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline at a pH of 6.5 plus or minus 0.3. Adjuplex adjuvant will be mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B, 6A-6B, and 8A-8B. Drug: VRC-FLUMOS0111-00-VP (FluMos-v1) The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013) |
- Serious adverse events [ Time Frame: Day 0 through Day 280 ]Occurrence of serious adverse events
- New chronic medical conditions [ Time Frame: Day 0 through Day 280 ]Occurrence of new-onset of chronic medical conditions
- Local Reactogenicity [ Time Frame: 7 days after product administration ]Occurrence of local reactogenicity signs and symptoms
- Unsolicited adverse events [ Time Frame: Day 0 through 28 days post product administration ]Occurrence of unsolicited non-serious adverse events
- Laboratory measures [ Time Frame: Day 0 through 28 days post product administration ]Occurrence of laboratory safety measures
- Systemic Reactogenicity [ Time Frame: 7 days after product administration ]Occurrence of systemic reactogenicity signs and symptoms
- Part B: Group 4A-4B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]antibody responses to 100 mcg of FluMos-v1 as a single dose
- Part B: Groups 4A-4B and 5A-5B [ Time Frame: 2 weeks after product administration ]Evaluate antibody responses between 100 mcg of FluMos-v1 and FluMos-v1 plus Adjuplex
- Part B: Group 6A-6B: If Enrolled: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]antibody responses to 60 mcg of FluMos-v1 plus Adjuplex as a single dose
- Part A: Group 1A-1B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]antibody responses to 20 and 60 mcg of FluMos-v1 as a single dose
- Part A: Group 2A-2B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]antibody responses to 60 mcg of FluMos-v1 as a single dose
- Part B: Group 5A-5B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]antibody responses to 100 mcg of FluMos-v1 plus Adjuplex as a single dose
- Part A: Group 3A-3B: vaccine-induced antibodies [ Time Frame: 2 weeks after product administration ]antibody responses to 60 of FluMos-v1 and Flucelvax as a single dose
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
A subject must meet all of the following criteria:
- Healthy adults between the ages of 18-50 years inclusive
- Based on history and physical examination, in good general health and without history of any of the conditions listed in the exclusion criteria
- Part A: Received at least one licensed influenza vaccine from 2016 through the 2019-2020 influenza season
- Part B and C: Received at least one licensed influenza vaccine from 2017 through the 2022-2023 influenza season
- Able and willing to complete the informed consent process
- Available for clinic visits for 40 weeks after enrollment and through an influenza season
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- 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:
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Breast-feeding or planning to become pregnant during the study
Subject has received any of the following substances:
- 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
- Blood products within 16 weeks prior to enrollment
- Live attenuated vaccines within 4 weeks prior to enrollment
- Inactivated vaccines within 2 weeks prior to enrollment
- Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
- Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule
- Current anti-TB prophylaxis or therapy
- Previous investigational H1, H2, or H10 influenza vaccines, including Part A participants
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Part A:
- Groups 1A, 2A, and 3A only: Receipt of the 2020-2021 season s licensed influenza vaccine at any time prior to enrollment
- Groups 1B, 2B, and 3B only: Receipt of the 2020-2021 season s licensed influenza vaccine within 4 months prior to enrollment.
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Part B and C:
- 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
- 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:
- Serious reactions to vaccines that preclude receipt of the study vaccination as determined by the investigator
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
- Asthma that is not well controlled
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- Thyroid disease that is not well controlled
- Idiopathic urticaria within the past year
- Autoimmune disease or immunodeficiency
- Hypertension that is not well controlled
- 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
- Malignancy that is active or history of malignancy that is likely to recur during the period of the study
- 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
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barre Syndrome
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04896086
| Contact: Floreliz H Mendoza | (301) 451-8715 | mendozaf@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: VRC Clinic 301-451-8715 vaccines@nih.gov | |
| Principal Investigator: | Richard L Wu, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Documents provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT04896086 |
| Other Study ID Numbers: |
10000410 000410-I |
| First Posted: | May 21, 2021 Key Record Dates |
| Last Update Posted: | March 28, 2023 |
| Last Verified: | March 24, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | .Only aggregate data will be shared. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Seasonal Influenza Flu Virus Respiratory Illness Viral Infection Experimental Vaccine |
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Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |