A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS

The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance.
Cohort 1: Approximately 450 participants will be assigned by chance to one of the following:
* Group A:Influenza and COVID-19 combination A vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm.
* Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm.
Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following:
* Group C: Influenza and COVID-19 combination B vaccine, given at the same time in one arm and placebo in the opposite arm.
* Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm.
Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following:
* Group E: Influenza and COVID-19 combination B vaccine.
* Group F: COVID-19 vaccine.
* Group G: Licenced influenza vaccine.
* Group H: Investigational influenza vaccine.
All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. This will help understand if the study medicine is safe.

Start Date20 Dec 2023

Sponsor / Collaborator

BioNTech SE

[+1]

NCT05596734 / CompletedPhase 1/2

A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS

Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either:
* qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations
* qIRV (22/23) at dose level 1,
* qIRV (22/23) at dose level 2, or
* bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV).
Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).

Start Date28 Oct 2022

Sponsor / Collaborator

BioNTech SE

[+1]

NCT05052697 / CompletedPhase 1/2

A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA IN HEALTHY INDIVIDUALS

This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB)
Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either:
1 of 4 dose levels of mIRV (either A or B Strain),
1 of 4 dose levels of bIRV (containing both A and B strains),
qIRV (at 1 dose level), or
A licensed quadrivalent influenza vaccine (QIV).
At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2:
mIRV encoding A strain at dose level 4, or
mIRV encoding B strain at dose level 4.
Substudy B
This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age:
2-Visit Schedules
2 doses of qIRV (at a dose level 1), administered 21 days apart.
2 doses of licensed QIV, administered 21 days apart (as a control group)
A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart.
1-Visit Schedules
A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2.
A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1.
A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations).
A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3.
1 dose of licensed QIV (as a control group).
Substudy B
In participants 18 to 64 years of age:
-A dose of qIRV encoding 2 A strains and 2 B strains at a dose level combination 1 or 2.

Start Date13 Sep 2021

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Bivalent influenza modRNA vaccine (BioNTech/Pfizer)

100 Translational Medicine associated with Bivalent influenza modRNA vaccine (BioNTech/Pfizer)

100 Patents (Medical) associated with Bivalent influenza modRNA vaccine (BioNTech/Pfizer)

Literatures (Medical) associated with Bivalent influenza modRNA vaccine (BioNTech/Pfizer)

01 Jan 2022·Vaccine

SARS-CoV-2-antibody response in health care workers after vaccination or natural infection in a longitudinal observational study

Article

Author: Becker, Ann-Kristin ; Knabbe, Cornelius ; Becher, Heiko ; Strate, Tim ; Guraya, Salman Yousuf ; Honarpisheh, Human ; Fischer, Bastian ; Herzberg, Jonas ; Vollmer, Tanja

BACKGROUNDFollowing a year of development, several vaccines have been approved to contain the global COVID-19 pandemic. Real world comparative data on immune response following vaccination or natural infection are rare.METHODSWe conducted a longitudinal observational study in employees at a secondary care hospital affected by the COVID-19 pandemic. Comparisons were made about the presence of anti-SARS-CoV-2 immunglobulin G (IgG) antibody ratio after natural infection, or vaccination with one or two doses of BioNTech/Pfizer (BNT162b2), or one dose of AstraZenca (Vaxzevria) vaccine.RESULTSWe found a 100% humoral response rate in participants after 2 doses of BNT162b2 vaccine. The antibody ratio in participants with one dose BNT162b2 and Vaxzevria did not differ significantly to those with previous PCR-confirmed infection, whereas this was significantly lower in comparison to two doses of BioNTech/Pfizer. We could not identify a correlation with previous comorbidities, obesity or age within this study. Smoking showed a negative effect on the antibody response (p = 0.006) CONCLUSION: Our data provide an overview about humoral immune response after natural SARS-CoV-2 infection or following vaccination, and supports the usage of booster vaccinations, especially in patients after a natural SARS-CoV-2 infection.

01 Feb 2005·Microbes and InfectionQ3 · MEDICINE

Sequence comparison between the extracellular domain of M2 protein human and avian influenza A virus provides new information for bivalent influenza vaccine design

Q3 · MEDICINE

Article

Author: Wanli Liu ; Jian Ding ; Yun Lu ; Peng Zou ; Ying-Hua Chen

To prevent the human and economic losses caused by human and avian influenza viruses, it is necessary to prepare safe bivalent influenza vaccines. Recent studies found that human influenza vaccines based on the extracellular domain of influenza M2 protein (M2e) induced broad-spectrum protective immunity in various antigen constructs. A prerequisite for using the M2e protein as a bivalent influenza vaccine component was to find out the sequence differences between human and non-human (avian or swine) influenza M2e proteins. Here, we completed such a comparison using 716 influenza M2e sequences available in Genbank. The results found one region on M2e protein consistent with host restriction specificities: PIRNEWGCRCN, PTRNGWECKCS and PIRNGWECRCN (aa10-20; the human, avian and swine specific M2e sequence, respectively). Interestingly, the comparison result was then validated by immunoblotting and enzyme-linked immunosorbent assay. The monoclonal antibody against the EVETPIRN sequence (aa6-13) of human M2e protein could weakly recognize avian M2e proteins bearing the EVETPTRN sequence (aa6-13) but failed to recognize avian M2e proteins bearing the EVETLTRN sequence (aa6-13). The data in this study provided useful information in the race to develop bivalent influenza vaccines against avian and human influenza A virus infection in human beings.

01 Dec 1977·Journal of Infectious DiseasesQ2 · MEDICINE

Response of Children with Cardiac Disease to the Bivalent Influenza A Vaccines

Q2 · MEDICINE

Article

Author: Hilman, B. C. ; Baucum, R. ; Lerman, S. J. ; Hall, C. B. ; McIntosh, K. ; Gross, P. A. ; Boyer, K. M. ; Cherry, J. D. ; Lauer, B. A. ; Modlin, J. F.

During the recent nationwide trials of influenza vaccine, 121 children with cardiac disease, aged three to 18 years, were evaluated with respect to their immune response and reaction rate after administration of a whole-virus or split-virus bivalent influenza A/New Jersey/76-A/Victoria/75 vaccine given as a single dose or two divided doses. The serologic response of the cardiac children did not differ significantly from that of the total group of high-risk children or normal children who recived the same vaccine. The major reaction to the vaccines was fever, which occurred in one-fourth to one-half of children receiving the whole-virus vaccines. The split-virus vaccines were generally well tolerated. The reaction index of the cardiac children was slightly lower than that of the normal children receiving the same vaccine during the single-dose trial but higher during the two-dose trial. The second dose was generally better tolerated than the first dose. Reactions in the children with cardiac disease could not be adequately evaluated according to specific diagnoses or functional disabilities.

100 Deals associated with Bivalent influenza modRNA vaccine (BioNTech/Pfizer)

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	US	BioNTech SE	20 Dec 2023
COVID-19	Phase 3	US	Pfizer Inc.	20 Dec 2023
Influenza, Human	Phase 3	US	Pfizer Inc.	20 Dec 2023
Influenza, Human	Phase 3	US	BioNTech SE	20 Dec 2023

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