An Efficacy, Immunogenicity and Safety Study Investigating an Adjuvanted SARS-CoV-2 Influenza Vaccine to Protect Against COVID-19 in Adults Over Aged 18 Years-old and Older

NCT04806529 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: V451_07
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary efficacy objective is to demonstrate the efficacy of aCoV2 versus a placebo to prevent the first occurrence of virologically-confirmed symptomatic COVID 19 according to the European Centre for Disease Prevention and Control (ECDC) COVID 19 case definition. The co-primary efficacy objective is to demonstrate the efficacy of aCoV2 versus a placebo to prevent virologically confirmed symptomatic COVID 19 defined by the US Food and Drug Administration (FDA) guidance.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance

  14 days post vaccination through until 12 months after the last vaccination.

• Co-primary endpoint - If successful, the co-primary measure of efficacy is preventing first-occurrence of symptomatic COVID-19 as defined by the US FDA guidance

  14 days post vaccination through until 12 months after the last vaccination.

Secondary Outcomes (3)

• Secondary endpoint #1 - preventing first occurrence of RT-PCR confirmed severe COVID-19

  14 days post vaccination through until 12 months after the last vaccination

• Secondary endpoint #2 - number of subjects hospitalized with RT-PCR-confirmed COVID-19 versus placebo

  14 days post vaccination through until 12 months after the last vaccination

• Secondary endpoint #3- number of subjects admitted to ICU with RT-PCR-confirmed COVID-19 versus placebo

  14 days post vaccination through until 12 months after the last vaccination

Study Arms (2)

Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)

EXPERIMENTAL

The experimental group will receive a 2-dose series of 0.5 mL of the study vaccine, administered intramuscularly (IM) into the deltoid muscle, preferably in the non-dominant arm, Day 1 and Day 29 (e.g. 28 days apart)

Drug: Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)

The Comparator Group - Placebo

PLACEBO COMPARATOR

The comparator group will receive a 2-dose series of 0.5 mL of the study vaccine, administered intramuscularly (IM) into the deltoid muscle, preferably in the non-dominant arm, Day 1 and Day 29 (e.g. 28 days apart)

Drug: Comparator

Interventions

Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) DRUG

Biological/Vaccine: Investigational adjuvanted SARS-CoV-2 Subunit vaccine

Also known as: Tthe aCoV2 group

Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)

Comparator DRUG

Biological/Vaccine: A dose of 0.5 mL saline for injection will be administrated to subjects randomized to receive the placebo

Also known as: The Placebo Group

The Comparator Group - Placebo

Eligibility Criteria

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

You may qualify if:

• Individuals 18 years of age or older on the day of informed consent.
• Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
• Individuals who can comply with study procedures including follow-up .
• Females of non-childbearing potential or females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the last study vaccination.

You may not qualify if:

• Females of childbearing potential3 who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so until 2 months after the last vaccination.
• Progressive, unstable or uncontrolled clinical conditions such as decompensated congestive heart failure, cardiac arrhythmia, unstable angina, acute coronary syndrome or any major organ failure
• Hypersensitivity, including allergy, to any component of vaccine (including the adjuvant, MF59C.1), medicinal products or medical equipment whose use is foreseen in this study.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
• History of Guillain-Barré Syndrome or acute disseminated encephalomyelitis (ADEM)
• Abnormal function of the immune system resulting from:
• Clinical conditions.
• Systemic administration of corticosteroids (PO/IV/IM) at any dose for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted.
• Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Received immunoglobulins or any blood products within 90 days prior to informed consent
• Received an investigational or non-registered medicinal product within 30 days prior to informed consent or an investigational coronavirus vaccine (SARS-CoV; MERS-CoV) at any time prior to informed consent
• Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
• Acute (severe) febrile illness (see Section 4.3)
• Known positive serology for human immunodeficiency virus (HIV) type 1 or 2 antibodies, hepatitis B virus surface antigen, or hepatitis C virus antibody
• Acute COVID-19 infection (positive COVID-19 test: nasopharyngeal swab) at screening, or Day 1

Sponsors & Collaborators

• Seqirus: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participant and observer-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Observer-blind design, 2-arm, parallel group with 1:1 randomization between aCoV2 and placebo, equally stratified by age in two age subgroups, 18-55 years and 56 years and older

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: December 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: April 9, 2022
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
• Access Criteria: Access: SEQIRUS considers requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the US and/or EU. This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication