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

Influenza Clinical Trial

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

Status Completed

Clinical Trial 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 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.

Clinical Trial Description

Design:

This is 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 are that the FluMos-v1 vaccine is safe and tolerable and will elicit an immune response. The primary objective is to evaluate the safety and tolerability of the investigational vaccine alone or with adjuvant in healthy adults. Secondary objectives relate 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 vaccine FluMos-v1 was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) and is composed of the following 4 influenza strains: Influenza A (H1: A/Idaho/07/2018 and H3: A/Perth/1008/2019) and Influenza B (Victoria lineage: B/Colorado/06/2017 and Yamagata lineage: B/Phuket/3073/2013. FluMos-v1 is 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) developed by Seqirus, Inc. and composed of the following 4 influenza strains: Influenza A (H1: A/Hawaii/70/2019 (H1N1) pdm09- like virus and H3: A/Hong Kong/45/2019 (H3N2)-like virus) and Influenza B: Victoria lineage: B/Washington/02/2019-like virus and Yamagata lineage: 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. All study enrollments and injections have been completed, and no further enrollments are planned in this study.

Adjuplex is provided as a sterile, pyrogen-free, homogeneous solution filled to 0.7 mL in 3-mL glass vials. Adjuplex is 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 (Registered Trademark) are administered intramuscularly (IM) in the deltoid muscle via needle and syringe.

Subjects:

Healthy adults between the ages of 18-50 years inclusive will be enrolled.

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 are optional, and a decision was made not to enroll the optional groups 6-8 in the study. All study enrollments and injections have been completed for groups 1-5, and no further enrollments are planned in this study.

The protocol requires 1 vaccination visit, about 8 follow-up visits, and a telephone contact on the day after vaccination. Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.

Study Duration:

Subjects will be evaluated for 40 weeks following vaccine administration and through an influenza season. ;

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Seasonal Influenza

• NCT number: NCT04896086
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 1
• Start date: May 24, 2021
• Completion date: February 8, 2024