Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years

NCT04956224 | Completed Phase 3 DMC

• 1 other identifier: VLA2001-304
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 8

Brief Summary

This is a A Phase III, Open label, Multicenter, Single Arm Study to assess the Safety, Tolerability and Immunogenicity of VLA2001 in volunteers aged ≥ 56 years. Approximately 300 participants are enrolled in a non-randomized manner.

Conditions

SARS-CoV-2 Virus Infection

Keywords

VLA2001; SARS-CoV-2 Virus Infection; COVID-19

Outcome Measures

Primary Outcomes (3)

• Frequency and severity of any Adverse Events (AE) up to Day 43 post-vaccination

  Day 43

• Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies

  Day 43

• Immune response as determined by the seroconversion rate (SCR) of SARS-CoV-2-specific neutralizing antibodies

  Day 43

Secondary Outcomes (23)

• Frequency and severity of solicited injection site and systemic reactions after each vaccination

  within 7 days

• Frequency and severity of any unsolicited Adverse Event (AE)

  until Day 43

• Frequency and severity of any unsolicited vaccine-related Adverse Event (AE)

  until Day 43

• Frequency and severity of any Serious Adverse Event (SAE)

  until Day 365

• Frequency and severity of any Adverse Event of Special Interest (AESI)

  until Day 365

Study Arms (1)

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 (Wuhan strain) 2 vaccinations 28 days apart Booster Vaccination on Visit B1

VLA2001

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must have read, understood, and signed the informed consent form (ICF).
• Participants of either gender aged 56 years or older at screening.
• Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up.
• Participant has a Body Mass Index (BMI) of 18.0-35.0 kg/m2, inclusive, at screening (Visit 0).
• Must be able to attend all visits of the study and comply with all study procedures, including daily completion of the e-diary for 7 days following each vaccination.
• Women of childbearing potential (WOCBP), who are sexually active with a man, must be able and willing to use at least 1 highly effective method of contraception (i.e. implant contraceptive, intra-uterine device (IUD) containing either copper or levonorgestrel, male sterilization \[vasectomy\], female sterilization, injectable contraceptive, oral contraceptive pill, vaginal contraceptive ring, barrier type of birth control measure) from study start until a minimum of 3 months after the last dose of study vaccine (i.e. 3 months after second dose or 3 months after booster dose).
• WOCBPs must have a negative pregnancy test prior to each vaccination.

You may not qualify if:

• Participant is pregnant or planning to become pregnant within 3 months after last study vaccine administration.
• History of allergy to any component of the vaccine.
• History of laboratory-confirmed SARS-CoV infection
• Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening.
• Participant has participated in a clinical study involving an investigational SARS-CoV-2 vaccine or has received or plans to receive a licensed SARS-CoV-2 vaccine during the duration of the study.
• Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever \> 100 °F (\> 37.8 °C) 48 hours before vaccination.
• Participant has a known or suspected defect of the immune system, such as participants with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to the expected day of randomization.
• Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled.
• History of drug dependency or current use of drug of abuse or alcohol abuse at screening.
• Significant blood loss (\> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to the expected day of first vaccination or the booster administration.
• History of clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
• Severe and uncontrolled ongoing autoimmune or inflammatory disease, history of Guillain-Barre syndrome or any other demyelinating condition.
• Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study.
• Prior/concomitant therapy:
• Receipt of immunoglobulin or another blood product within the 3 months before expected day of first vaccination or the booster administration in this study or those who expect to receive immunoglobulin or another blood product during this study.

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (8)

Southern Clinical Trials Waitemata

Auckland, Birkenhead, 0626, New Zealand

Location

Lakeland Clinical Trials Waikato

Hamilton, Nawton, 3200, New Zealand

Location

Southern Clinical Trials Totara

Auckland, New Lynn, 0600, New Zealand

Location

Lakeland Clinical Trials Culloden

Papamoa, Papamoa Beach, 3118, New Zealand

Location

Southern Clinical Trials Remuera

Auckland, Remuera, 1050, New Zealand

Location

Southern Clinical Trials Tasman

Nelson, Stoke, 7011, New Zealand

Location

Southern Clinical Trials Christchurch

Christchurch, 8013, New Zealand

Location

Lakeland Clinical Trials Rotorua

Rotorua, 3010, New Zealand

Location

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

Study Officials

• Valneva Clinical Deveopment

  Valneva Austria GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 9, 2021
• Study Start: August 9, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 18, 2022
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (8)