Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy Subjects

NCT04671017 | Completed Phase 1 Results DMC

• 1 other identifier: VLA2001-201
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 4

Brief Summary

A multicenter, 3-arm randomized dose finding study in the UK to evaluate safety, tolerability and immunogenicity of a vaccine candidate against Covid-19. 150 healthy volunteers will be enrolled and receive two shots of the vaccine candidate. All participants who receive two doses of the vaccine candidate will be invited to participate in the Booster phase.

Conditions

SARS-CoV-2 Virus Infection

Keywords

VLA2001; SARS-CoV-2 Virus Infection; Covid-19; inactivated-adjuvanted SARS-CoV-2 virus vaccine

Outcome Measures

Primary Outcomes (2)

• Frequency of Solicited AEs (Local and Systemic Reactions) Within 7 Days After Any Vaccination of the Primary Vaccination Series

  within 7 days after any vaccination

• Geometric Mean Titre (GMT) for Neutralizing Antibodies Against SARS-CoV-2 Determined by Wild-type Virus Neutralizing Assay

  Day 36

Secondary Outcomes (28)

• Frequency of Any Unsolicited AE

  until Day 36

• Frequency of Any Vaccine-related AE

  until Day 36

• Frequency and Severity of Any AE

  until Day 208

• Frequency and Severity of Any Vaccine-related AE

  until Day 208

• Frequency of Any SAE

  until Day 36

Study Arms (4)

Low Dose: VLA2001

EXPERIMENTAL

Biological: VLA2001

Medium Dose: VLA2001

EXPERIMENTAL

Biological: VLA2001

High Dose: VLA2001

EXPERIMENTAL

Biological: VLA2001

Booster: High Dose: VLA2001

EXPERIMENTAL

Biological: VLA2001

Interventions

VLA2001 BIOLOGICAL

whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG) 1018 in combination with aluminium hydroxide

Booster: High Dose: VLA2001; High Dose: VLA2001; Low Dose: VLA2001; Medium Dose: VLA2001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is 18 to 55 years of age
• Participant who has a smart phone and is willing and able to install and use the eDiary.
• Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures.
• Participant is generally healthy as determined by the Investigator
• Participant has a Body Mass Index (BMI) of 18.0-30.0 kg/m2
• If subject is of childbearing potential:
• Participant has practiced an adequate method of contraception during the 30 days before screening (Visit 0).
• Participant has a negative serum or urine pregnancy test at screening (Visit 0) or Visit 1, respectively.
• Participant agrees to employ adequate birth control measures up to Day 106 (Visit 5).
• B1. Participant has received complete VLA2001 primary immunization (two vaccinations according to the protocol)
• B2. Participant who has a smart phone and is willing and able to install and use the e-Diary.
• B3. Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures.
• B4. Participant is generally healthy as determined by the Investigator's clinical judgement
• B5. If a participant is of childbearing potential:
• Participant has a negative urine pregnancy test at Visit 7 prior to booster vaccination.

You may not qualify if:

• Clinically significant infection or other acute illness, including fever ≥ 38°C within 24 hours prior to the planned study vaccination.
• History of laboratory-confirmed SARS-CoV-2 infection.
• Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening (Visit 0).
• Participant has participated in a clinical study involving an investigational SARS-CoV-2 vaccine.
• Participant has an acute or recent infection not due to SARS-CoV-2
• Participant has a history of SARS-CoV-1 or MERS infection (self-reported)
• Participant tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Participant has received any vaccine within 30 days prior Visit 1 other than the study intervention, with the exception of the seasonal influenza vaccination.
• Participant has abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator.
• Participants with either medical history of or present acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation or completion of the study, based on Investigator's clinical judgement.
• Participants with underlying diseases with a high risk of developing severe COVID-19 symptoms if infected
• Participant has a known or suspected defect of the immune system, such as Participants with congenital or acquired immune deficiency
• Participant received immuno-suppressive therapy within 4 weeks prior to Visit 1 or receipt of immunosuppressive therapy is expected during the study.
• Participant has a history of any vaccine related contraindicating event
• Participant presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

Sponsors & Collaborators

• Valneva Austria GmbH: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (4)

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

University Hospital Bristol and Weston NHS Foundation Trust

Bristol, BS1 3NU, United Kingdom

Location

Newcastle University Medical School

Newcastle, NE7 7DN, United Kingdom

Location

Southampton NIHR Clinical Research Facility

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Lazarus R, Taucher C, Brown C, Corbic Ramljak I, Danon L, Dubischar K, Duncan CJA, Eder-Lingelbach S, Faust SN, Green C, Gokani K, Hochreiter R, Wright JK, Kwon D, Middleditch A, Munro APS, Naker K, Penciu F, Price D, Querton B, Riaz T, Ross-Russell A, Sanchez-Gonzalez A, Wardle H, Warren S, Finn A; Valneva Phase 1 Trial Group. Safety and immunogenicity of the inactivated whole-virus adjuvanted COVID-19 vaccine VLA2001: A randomized, dose escalation, double-blind phase 1/2 clinical trial in healthy adults. J Infect. 2022 Sep;85(3):306-317. doi: 10.1016/j.jinf.2022.06.009. Epub 2022 Jun 16.

  PMID: 35718205 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

VLA2001 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Strategy Manager
• Organization: Valneva Austria GmbH

office@valneva.com

+43 1 206 20

Study Officials

• Valneva Clinical Development

  Valneva Austria GmbH

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1. st phase is open-label 2. nd phase is double-blind randomized (Participant, Investigator ) 3. rd phase is open-label phase
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1. st phase Sequential (open-label phase) 2. nd phase Parallel Assignment (double-blinded randomized phase ) 3. rd phase Parallel Assignment (open-label phase)

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 17, 2020
• Study Start: December 16, 2020
• Primary Completion: February 26, 2021
• Study Completion: April 6, 2022
• Last Updated: April 22, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-04

Locations

GB (4)