Immunogenicity After COVID-19 Vaccines in Adapted Schedules

NCT06189040 | Completed Phase 4

• 1 other identifier: IMCOVAS
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this clinical trial is to compare different Coronavirus Disease 2019 (COVID-19) vaccination schedules in healthy adults that have not yet been exposed to SARS-CoV-2, the virus causing COVID-19. The main questions it aims to answer are:

• BNT162b2 (30µg) on day 0, followed by BNT162b2 (30µg) on day 28
• BNT162b2 (20µg) on day 0, followed by BNT162b2 (20µg) on day 28
• BNT162b2 (30µg) on day 0, followed by BNT162b2 (30µg) on day 84
• BNT162b2 (30µg) on day 0, followed by mRNA-1273 (100µg) on day 28
• BNT162b2 (30µg) on day 0, followed by ChAdOx1-S \[recombinant\] on day 28
• BNT162b2 (6µg, intradermal administration) on day 0, followed by BNT162b2 (6µg, intradermal administration) on day 28
• mRNA-1273 (100µg) on day 0, followed by mRNA-1273 (100µg) on day 28
• mRNA-1273 (50µg) on day 0, followed by mRNA-1273 (50µg) on day 28

Conditions

Coronavirus Disease 2019; COVID-19

Outcome Measures

Primary Outcomes (1)

• Geometric mean titre of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain

  28 days after the administration of the second study vaccine

Secondary Outcomes (7)

• Occurrence of solicited adverse events

  within 5 days after the administration of each study vaccine

• Occurrence of unsolicited adverse events

  within 14 days after the administration of each study vaccine

• Occurrence of medically attended adverse events, adverse of special interest and serious adverse events

  through study completion (up to 1 year after the first study vaccination)

• Occurrence of absenteeism

  within 5 days after the administration of each study vaccine

• Geometric mean titre of antibodies binding to the Receptor Binding Domain of SARS-CoV-2 S protein of the ancestral D614 SARS-CoV-2 virus strain

  28 days after the administration of the third COVID-19 vaccine

Other Outcomes (2)

• PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms (any severity)

  through study completion (up to 1 year after the first study vaccination)

• PCR-confirmed SARS-CoV-2 infection with severe COVID-19 (hospitalization, death)

  through study completion (up to 1 year after the first study vaccination)

Study Arms (8)

BNT162b2 regular schedule

ACTIVE COMPARATOR

day 0: intramuscular administration of BNT162b2 (30µg) day 28: intramuscular administration of BNT162b2 (30µg)

Drug: BNT162b2 30µg

BNT162b2 + mRNA-1273 schedule

EXPERIMENTAL

day 0: intramuscular administration of BNT162b2 (30µg) day 28: intramuscular administration of mRNA-1273 (100µg)

Drug: BNT162b2 30µg; Drug: mRNA-1273 100µg

BNT162b2 + ChAdOx1-S schedule

EXPERIMENTAL

day 0: intramuscular administration of BNT162b2 (30µg) day 28: intramuscular administration of ChAdOx1-S \[recombinant\] (not less than 2.5x10\^8 infectious units)

Drug: BNT162b2 30µg; Drug: ChAdOx1-S [Recombinant]

BNT162b2 low dose schedule

EXPERIMENTAL

day 0: intramuscular administration of BNT162b2 (20µg) day 28: intramuscular administration of BNT162b2 (20µg)

Drug: BNT162b2 20µg

BNT162b2 long-interval schedule

EXPERIMENTAL

day 0: intramuscular administration of BNT162b2 (30µg) day 84: intramuscular administration of BNT162b2 (30µg)

Drug: BNT162b2 30µg

BNT162b2 intradermal schedule

EXPERIMENTAL

day 0: intradermal administration of BNT162b2 (6µg) day 28: intradermal administration of BNT162b2 (6µg)

Drug: BNT162b2 6µg

mRNA-1273 regular schedule

ACTIVE COMPARATOR

day 0: intramuscular administration of mRNA-1273 (100µg) day 28: intramuscular administration of mRNA-1273 (100µg)

Drug: mRNA-1273 100µg

mRNA-1273 low dose schedule

EXPERIMENTAL

day 0: intramuscular administration of mRNA-1273 (50µg) day 28: intramuscular administration of mRNA-1273 (50µg)

Drug: mRNA-1273 50µg

Interventions

BNT162b2 30µg DRUG

intramuscular administration of 30µg

BNT162b2 + ChAdOx1-S schedule; BNT162b2 + mRNA-1273 schedule; BNT162b2 long-interval schedule; BNT162b2 regular schedule

BNT162b2 20µg DRUG

intramuscular administration of 20µg

BNT162b2 low dose schedule

BNT162b2 6µg DRUG

intradermal administration of 6µg

BNT162b2 intradermal schedule

mRNA-1273 100µg DRUG

intramuscular administration of 100µg

BNT162b2 + mRNA-1273 schedule; mRNA-1273 regular schedule

mRNA-1273 50µg DRUG

intramuscular administration of 50µg

mRNA-1273 low dose schedule

ChAdOx1-S [Recombinant] DRUG

intramuscular administration of not less than 2.5 x 10\^8 infectious units

BNT162b2 + ChAdOx1-S schedule

Eligibility Criteria

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

You may qualify if:

• Male, female, or X (non-binary gender) subjects, 18-55y inclusive on the day of signing of the ICF
• Provision of signed and dated informed consent form
• Available at all provided timepoints of the study and is not planning to move abroad for the whole duration of the study
• In good general health as evidenced by medical history and/or physical examination or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
• Willing and able to comply with all study procedures
• Participants born female must be either:
• of childbearing potential and using effective contraception for at least 1 month prior to screening and agree to use such a method during study participation until 1 months following the last study dose administration.
• of non-childbearing potential.

You may not qualify if:

• Previous clinical or microbiological confirmed diagnosis of COVID-19.
• Unstable, severe, progressive disease in the past 3 months.
• History of malignancy during the past 5 years.
• History of severe adverse reaction associated and/or anaphylaxis with a vaccine.
• Known allergic reactions of any severity to polyethylene glycol \[PEG\] or to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG).
• Primary or secondary immunodeficiency disorders (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection…).
• Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day, or equivalent. Inhaled, nasal, opthalmic and topical steroids are allowed.
• Pregnancy or lactation.
• History of drug or alcohol abuse.
• Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk, including relevant psychiatric diagnosis.
• Previous vaccination or planned to accept other vaccination during this study with any coronavirus vaccine outside this study.
• Previous vaccination or planned to accept other vaccination during this study with any coronavirus vaccine outside this study, with the exception of a third COVID-19 vaccine during fall/winter '21-'22.
• Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
• Participation in another clinical trial with an IMP or a new medical device within 28 days prior to study entry and/or during study participation.
• Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as first degree family members and household members of the employees or the investigator, or an employee of the sponsor.

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (4)

Centre for the Evaluation of Vaccination (CEV)

Edegem, Antwerp, 2650, Belgium

Location

Centre for Vaccinology (CEVAC)

Ghent, East Flanders, 9000, Belgium

Location

Institute of Tropical Medicine (ITM)

Antwerp, 2000, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

Related Publications (1)

• Steenackers K, Hanning N, Bruckers L, Desombere I, Marchant A, Arien KK, Georges D, Soentjens P, D'Onofrio V, Hites M, Berens-Riha N, De Coster I, Damme PV. Humoral immune response against SARS-CoV-2 after adapted COVID-19 vaccine schedules in healthy adults: The IMCOVAS randomized clinical trial. Vaccine. 2024 Nov 14;42(25):126117. doi: 10.1016/j.vaccine.2024.07.018. Epub 2024 Jul 16.

  PMID: 39019657 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273; ChAdOx1 nCoV-19

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

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors; Vaccines, DNA

Study Officials

• Katie Steenackers, MD

  Centre for the Evaluation of Vaccination

  PRINCIPAL INVESTIGATOR

• Nikita Hanning, MD

  Centre for the Evaluation of Vaccination

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded up to the venous blood draw used to assess the primary endpoint (day 112 for the long-interval treatment arm, day 56 for all other treatment arms). Afterwards, participants were unblinded because the registration of all administered COVID-19 vaccines was required by the Belgian government.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Centre for the Evaluation of Vaccination (CEV)

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 3, 2024
• Study Start: May 26, 2021
• Primary Completion: November 3, 2021
• Study Completion: July 8, 2022
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Datasets will become available - upon request - after publication of the main results in a peer-reviewed scientific journal.
• Access Criteria: The datasets used and analyzed during the current study are available from the central contact person on reasonable request, following material transfer agreements.

Locations

BE (4)