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CVSQIV

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |BioNTech SE|Last Updated: Jun 6, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

CVSQIV · 1 trial · 1 indication

Phase 1 1
NCT05252338A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVSQIV in Healthy AdultsInfluenza
COMPLETED240 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVSQIV in Healthy Adults
Influenza
NCT05252338240
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Study Endpoints

Primary Endpoints

The frequencies of Grade 3 ARs and any SAR within at least 20 hours after the trial vaccine administration by dose level, for decisions on subsequent vaccination of additional sentinel subjects with the same dose level.
up to day 2
The frequencies of Grade 3 ARs and any SAR within at least 60 hours after the trial vaccine administration by dose level, for decisions on dose escalation as well as continuation of enrollment at the same dose level.
up to day 3
The frequencies, intensities and duration of solicited local ARs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
up to day 8
The frequencies, intensities, duration and relationship to trial vaccination of solicited systemic AEs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
up to day 8
The occurrence, intensities and relationship to trial vaccination of unsolicited AEs on the day of vaccination and the following 28 days by dose level, for the characterization of the safety and reactogenicity profile.
up to day 29
The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial, for the characterization of the safety and reactogenicity profile.
through study completion, an average of 6 months

Secondary Endpoints

For each antigen, the proportion of subjects with antigen-specific serum HAI assay titers.
On Day 22 and Day 183
For each antigen, geometric mean titers (GMTs) of antigen-specific HAI antibody titers.
On Day 22 and Day 183
For each antigen, the proportion of subjects with antigen-specific seroconversion measured by HAI assay.
On Day 22 and Day 183
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Younger Adults group aged 18-55 yearsEXPERIMENTALSubjects will be enrolled in a staggered manner in up to 5 dose levels (provisional dose levels of 3, 6, 12, 20 and 28µg). All subjects will receive a single dose of CVSQIV on Day 1.
Adults group aged ≥65 yearsEXPERIMENTALSubjects will be enrolled in a staggered manner in up to 5 dose levels (provisional dose levels of 3, 6, 12, 20 and 28µg). All subjects will receive a single dose of CVSQIV on Day 1.

Interventions

NameTypeDescription
CVSQIVBIOLOGICALParticipants will receive an intramuscular injection by needle in the deltoid area.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Healthy male or female subjects between the ages of 18 and 55 years, inclusive, at enrollment (Younger Adults groups) or aged ≥65 years at enrollment (Older Adults groups). A healthy subject is defined as an individual who is in good general health, according to the Investigat...

Countries:Panama
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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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Frequently asked questions about CVSQIV

What is CVSQIV used for?

CVSQIV is an investigational monoclonal antibody being developed for influenza. It is currently in Phase 1 clinical development, meaning it is not yet approved and is still being studied for safety and immunogenicity in healthy adults.

Who makes CVSQIV?

CVSQIV is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational influenza vaccine.

What phase is CVSQIV in?

CVSQIV is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it is not yet approved for use outside of clinical research.

What clinical trials is CVSQIV in?

CVSQIV has one completed Phase 1 clinical trial, identified as NCT05252338. This study evaluated the safety, reactogenicity, and immunogenicity of the vaccine in 240 healthy adults aged 18 years and older in Panama.

Is CVSQIV a vaccine or a monoclonal antibody?

CVSQIV is described as a monoclonal antibody modality, but it is being studied as a vaccine for influenza. The Phase 1 trial evaluates its safety and immunogenicity, which are typical measures for vaccine candidates.