Phase 1 N=63 Prevention

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

Influenza · Seasonal Influenza

Bottom Line

View on ClinicalTrials.gov: NCT04896086 ↗

Enrolled (actual)

Serious AEs

1.6%

Results posted

Mar 2025

Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration — 4; 12; 9; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: VRC-GENADJ0110-AP-NV (Adjuplex) (Drug); Flucelvax (Biological); VRC-FLUMOS0111-00-VP (FluMos-v1) (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	4; 12; 9; 8; 0; 1	—
PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	4; 13; 11; 9; 2; 1	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs) Following Product Administration	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	2; 2; 1; 1; 0; 2	—
PRIMARY Number of Participants With New Chronic Medical Conditions Following Product Administration	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	1; 0; 0; 0; 0; 1	—
PRIMARY Number of Participants With Influenza or Influenza-like Illness (ILIs) Following Product Administration	0; 0; 0; 0; 1; 0	—
SECONDARY Antibody Response Following the Completion of Vaccination	53182; 87179; 76775; 89289; 90907; 76333	—

Summary

Background: Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and sometimes the lungs. Vaccines are given to teach the body to prevent or fight infection. Researchers want to study a new vaccine to prevent the seasonal flu. Objective: To see if the FluMos-v1 vaccine is safe and how the body responds to it. Eligibility: Healthy adults ages 18-50 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.

Eligibility Criteria

INCLUSION CRITERIA:

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) =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:
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.
Part B and C:
Groups 4A and 5A only: Receipt of the 2021-2022 or 2022-2023 season's licensed influenza vaccine at any time prior to enrollment
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:

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 precau

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04896086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.