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| ID | Type | Description | Link |
|---|---|---|---|
| 000410-I |
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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 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.
Design:
This was a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1). The hypotheses were that the FluMos-v1 vaccine is safe and tolerable and would elicit an immune response. The primary objective was to evaluate the safety and tolerability of the investigational vaccine alone or with adjuvant in healthy adults. Secondary objectives were related to immunogenicity of the investigational vaccine and dosing regimen compared with the licensed inactivated seasonal Flucelvax (Registered Trademark) quadrivalent influenza vaccine (QIV) in healthy adults.
Study Products:
The investigational nanoparticle vaccine VRC-FLUMOS0111-00-VP (FluMos-v1) was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID). FluMos-v1 is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. FluMos-v1 was supplied in a single-use vial at a concentration of 180 mcg/mL.
In Part A, FluMos-v1 was compared to licensed 2020-2021 QIV Flucelvax (Registered Trademark) that was developed by Seqirus, Inc. and formulated with the following 4 influenza strains: A/Hawaii/70/2019 (H1N1) pdm09-like virus, A/Hong Kong/45/2019 (H3N2)-like virus, B/Washington/02/2019-like virus, and B/Phuket/3073/2013-like virus.
In Part B, a higher dose of FluMos-v1 was tested that more closely matches the amount of each HA antigen in Flucelvax. The adjuvant Adjuplex (Registered Trademark) was added to FluMos-v1 to evaluate the potential for increased immunogenicity.
Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the 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 was provided as a sterile, pyrogen-free, homogeneous solution filled to 0.7 mL in 3-mL glass vials. Adjuplex was mixed with study products in the pharmacy during preparation prior to vaccination at a 20% dose by volume.
FluMos-v1, FluMos-V1 plus Adjuplex, and Flucelvax were administered intramuscularly (IM) in the deltoid muscle via needle and syringe.
Participants:
A total of 63 participants enrolled as follows:
Part A
Part A, Group 1 (20 mcg FluMos-v1): 5 participants
Group 1A (N=1): Did not receive 2020-2021 season's licensed influenza vaccine at any time prior to enrollment
Group 1B (N=4): Receipt of the 2020-2021 season's licensed influenza vaccine more than 4 months prior to enrollment
Part A, Group 2 (60 mcg FluMos-v1): 15 participants
Group 2A (N=4): Did not receive 2020-2021 season's licensed influenza vaccine at any time prior to enrollment
Group 2B (N=11): Receipt of the 2020-2021 season's licensed influenza vaccine more than 4 months prior to enrollment
Part A, Group 3 (60 mcg Flucelvax®): 15 participants
Group 3A (N=3): Did not receive 2020-2021 season's licensed influenza vaccine at any time prior to enrollment
Group 3B (N=12): Receipt of the 2020-2021 season's licensed influenza vaccine more than 4 months prior to enrollment
Part B
Part B, Group 4 (100 mcg FluMos-v1): 15 participants
Group 4A (N=1): Did not receive 2021-2022 or 2022-2023 season's licensed influenza vaccine at any time prior to enrollment
Group 4B (N=14): Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine more than 4 months prior to enrollment
Part B, Group 5 (100 mcg FluMos-v1 + Adjuplex (20% v/v)): 13 participants
Group 5A (N=2): Did not receive 2021-2022 or 2022-2023 season's licensed influenza vaccine at any time prior to enrollment
Group 5B (N=11): Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine more than 4 months prior to enrollment
Study Plan:
In Part A, the study evaluated the safety, tolerability, and immunogenicity of a single dose of FluMos-v1 vaccine alone in a dose-escalation design.
In Part B, the study evaluated the safety, tolerability, and immunogenicity of a single dose of FluMos-v1 vaccine with or without Adjuplex.
Group 6 and Part C were optional, and a decision was made not to enroll the optional Groups 6-8 in the study.
The protocol required 1 vaccination visit, about 8 follow-up visits, and a telephone contact on the day after vaccination. Solicited reactogenicity were evaluated using a 7-day diary card. Assessment of vaccine safety included clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.
Study Duration:
Participants were evaluated for 40 weeks following vaccine administration including through an influenza season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg) | Experimental | FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe |
|
| Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | Experimental | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe |
|
| Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Active Comparator | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe |
|
| Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | Experimental | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe |
|
| Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | Experimental | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC-GENADJ0110-AP-NV (Adjuplex) | Drug | Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration | Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007. | 7 days after product administration |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration | Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007. | 7 days after product administration |
| Number of Participants With Serious Adverse Events (SAEs) Following Product Administration | SAEs were recorded from receipt of product administration through the last study visit at Week 40. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Response Following the Completion of Vaccination | FluMos-v1-specific antibody titers were measured by Electrochemiluminescence Immunoassay (ECLIA) using a Meso Scale Discovery (MSD) platform. FluMos-v1 was biotinylated at an AviTag site located proximal to the C-terminus from the trimer foldon and bound to MSD streptavidin-coated plates. Serum samples collected at 2 weeks after product administration were assayed alongside healthy pooled human sera (not from this trial) as a reference standard. Binding of the reference standard to FluMos-v1 was assigned a stock concentration of 54000 arbitrary units per milliliter (AU/mL). Serial dilutions of sample within the dynamic range of the standard curve were interpolated to assign a sample concentration in AU/mL. Group geometric mean AU/mL values and 95% confidence intervals are reported. |
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Participant must have met 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: 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
White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
Total lymphocyte count >=800 cells/microliter
Platelets = 125,000 - 500,000 cells/microliter
Hemoglobin within institutional normal range or accompanied by the PI or designee approval
Alanine aminotransferase (ALT) <=1.25 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) <=1.25 x institutional ULN
Alkaline phosphatase (ALP) <1.1 x institutional ULN
Total bilirubin within institutional normal range or accompanied by the PI or designee approval.
Serum creatinine <=1.1 x institutional ULN
Negative for HIV infection by an FDA-approved method of detection
Criteria applicable to women of childbearing potential:
Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment
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:
Breast-feeding or planning to become pregnant during the study
Participant 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
Part A:
Part B and C:
Participant had 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 participant's ability to give informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Lesia Dropulic, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21083388 | Background | Lambert LC, Fauci AS. Influenza vaccines for the future. N Engl J Med. 2010 Nov 18;363(21):2036-44. doi: 10.1056/NEJMra1002842. No abstract available. | |
| 30742080 | Background | 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. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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Individual participant data (IPD) is not shared because it has limited value in a small phase 1 trial of healthy volunteers. We instead report non-IPD (aggregate) data as required in ClinicalTrials.gov.
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Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg) | FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 11, 2025 |
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Dose Escalation
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|
|
| Flucelvax | Biological | Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
|
| VRC-FLUMOS0111-00-VP (FluMos-v1) | Drug | FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
|
|
| Day 0 after product administration through Day 280, up to Week 40 |
| Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration | Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 through 28 days post product administration, up to Week 4 |
| Number of Participants With New Chronic Medical Conditions Following Product Administration | New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 40. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 after product administration through Day 280, up to Week 40 |
| Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration | Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete Blood Count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Baseline, Day 0, Day 14, and 28. Creatinine results were collected at Baseline, Day 0 and Day 14. Institutional lab normal ranges as well as Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used. | Day 0 through 28 days post product administration, up to Week 4 |
| Number of Participants With Influenza or Influenza-like Illness (ILIs) Following Product Administration | Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the study product administration through the last study visit. ILI was defined as fever (temperature of 100 degrees F [37.8 degrees C] or greater) and a cough and/or sore throat in the absence of a known cause other than influenza. Collection of nasopharyngeal swabs were used for laboratory confirmation of influenza by polymerase chain reaction (PCR) in participants who met criteria for ILI. Subsequently, results of any reported laboratory testing for identification of pathogens were included for cases meeting initial criteria for ILI. The severity of illness in participants with laboratory confirmed influenza illness were captured on a case report form rather than on an Adverse Event (AE) form. | Day 0 after product administration through Day 280, up to Week 40 |
| Baseline to 2 weeks after product administration |
| 33762730 | Background | 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. |
| 38402303 | Background | 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. |
| 37451877 | Derived | Alabanza C, Gavrilov V, Scott T, Yang RS, Gowetski DB, Gall JG, Paula Lei Q. Quantitation of strain-specific hemagglutinin trimers in mosaic quadrivalent influenza nanoparticle vaccine by ELISA. Vaccine. 2023 Aug 7;41(35):5201-5210. doi: 10.1016/j.vaccine.2023.07.009. Epub 2023 Jul 12. |
| FG001 | Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| FG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| FG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| FG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| Completed Product Administration |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Population includes all enrolled participants. Age represents age at enrollment day. Height and weight (used for BMI) were from the enrollment evaluation per the eligibility criterion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg) | FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| BG001 | Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| BG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| BG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| BG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age represents age at enrollment day. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Age represents age at enrollment day. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Height and weight (used for BMI) were from the enrollment evaluation per the eligibility criterion. | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration | Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007. | Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. | Posted | Count of Participants | Participants | 7 days after product administration |
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| Primary | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration | Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007. | Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. | Posted | Count of Participants | Participants | 7 days after product administration |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration | SAEs were recorded from receipt of product administration through the last study visit at Week 40. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. | Posted | Count of Participants | Participants | Day 0 after product administration through Day 280, up to Week 40 |
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| Primary | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration | Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. | Posted | Count of Participants | Participants | Day 0 through 28 days post product administration, up to Week 4 |
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| Primary | Number of Participants With New Chronic Medical Conditions Following Product Administration | New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 40. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. | Posted | Count of Participants | Participants | Day 0 after product administration through Day 280, up to Week 40 |
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| Primary | Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration | Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete Blood Count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Baseline, Day 0, Day 14, and 28. Creatinine results were collected at Baseline, Day 0 and Day 14. Institutional lab normal ranges as well as Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used. | Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. | Posted | Count of Participants | Participants | Day 0 through 28 days post product administration, up to Week 4 |
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| Primary | Number of Participants With Influenza or Influenza-like Illness (ILIs) Following Product Administration | Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the study product administration through the last study visit. ILI was defined as fever (temperature of 100 degrees F [37.8 degrees C] or greater) and a cough and/or sore throat in the absence of a known cause other than influenza. Collection of nasopharyngeal swabs were used for laboratory confirmation of influenza by polymerase chain reaction (PCR) in participants who met criteria for ILI. Subsequently, results of any reported laboratory testing for identification of pathogens were included for cases meeting initial criteria for ILI. The severity of illness in participants with laboratory confirmed influenza illness were captured on a case report form rather than on an Adverse Event (AE) form. | Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. | Posted | Count of Participants | Participants | Day 0 after product administration through Day 280, up to Week 40 |
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| Secondary | Antibody Response Following the Completion of Vaccination | FluMos-v1-specific antibody titers were measured by Electrochemiluminescence Immunoassay (ECLIA) using a Meso Scale Discovery (MSD) platform. FluMos-v1 was biotinylated at an AviTag site located proximal to the C-terminus from the trimer foldon and bound to MSD streptavidin-coated plates. Serum samples collected at 2 weeks after product administration were assayed alongside healthy pooled human sera (not from this trial) as a reference standard. Binding of the reference standard to FluMos-v1 was assigned a stock concentration of 54000 arbitrary units per milliliter (AU/mL). Serial dilutions of sample within the dynamic range of the standard curve were interpolated to assign a sample concentration in AU/mL. Group geometric mean AU/mL values and 95% confidence intervals are reported. | Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. Twelve (12) out of 13 participants were analyzed in Group 4 at Week 2 post administration, as serum was not collected for one Group 4 participant at Week 2. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | Baseline to 2 weeks after product administration |
|
Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg) | FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG001 | Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. | 0 | 15 | 1 | 15 | 8 | 15 |
| EG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. | 0 | 15 | 0 | 15 | 6 | 15 |
| EG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. | 0 | 13 | 0 | 13 | 5 | 13 |
| EG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. | 0 | 13 | 0 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant oligodendroglioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Hangover | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Administration site pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Administration site swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment | Joint Pain |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Administration site pruritis | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VRC Clinical Trials Program Leadership | Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health | 301-451-8715 | ctpleadership@mail.nih.gov |
| Apr 10, 2025 |
| Prot_SAP_ICF_002.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| 31-40 years |
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| 41-50 years |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| Mild |
|
| Moderate |
|
| Severe |
|
| Swelling |
|
| Redness |
|
| Pruritis (Itching) |
|
| Bruising |
|
| Any Local Symptom |
|
| OG001 | Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| OG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
|
|
| OG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| OG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
|
|
| OG001 | Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| OG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
|
|
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| OG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
|
|
| OG001 | Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| OG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
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| OG001 | Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| OG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
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| OG001 | Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg) | FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG002 | Part A, Group 3 (3A-3B): Flucelvax (60 mcg) | Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season. |
| OG003 | Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg) | FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
| OG004 | Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v) | FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B. VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013. |
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| Mild |
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| Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Mild |
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| Moderate |
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| Severe |
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| Mild |
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| Moderate |
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