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COVID-19Phase 1/2NCT05602961

A Phase I/II Study of GLB-COV2-043 as a COVID-19 Vaccine Booster

A Phase 1/2 study testing GLB-COV2-043 and BNT162b2/COMIRNATY® in people with COVID-19, run by GreenLight Biosciences, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The scope of this Phase I/II study is to determine whether GLB-COV2-043 is a promising booster vaccine candidate component for adult participants who have received the 2-dose priming course of the mRNA BNT162b2 vaccine against COVID-19, or the 2-dose priming course and a third BNT162b2 injection (i.e., as a… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
GLB-COV2-043 and BNT162b2/COMIRNATY®
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
21 Feb 2023to Sep 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The participant is ≥ 18 years of age (yoa) at the time of signing the informed consent form.
  • The participant provides documentation of completing the priming schedule, or the priming schedule and a third vaccination (i.e., a "booster"), with the mRNA BNT162b2 vaccine against SARS-CoV-2 at least 3 months before randomization.
  • The participant is willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
  • In the judgement of the investigator or designee, the participant has understood the information provided and the potential impact and/or risks linked to study vaccine administration and to participation in the study; written informed consent will be obtained from the participant before any study-related procedure is performed.
  • In the judgement of the investigator or designee, the participant is in good health as assessed by medical history, physical examination, and laboratory tests.
  • If a person of childbearing potential and sexually active, the participant is willing to commit to use an effective method of contraception from at least 1 week before randomization to 52 weeks after randomization.
  • If a person of childbearing potential, the participant is willing to undergo urine pregnancy tests as required by the protocol.

Who cannot join

  • Medical conditions. The participant has:
  • Current COVID-19 as determined by a positive SARS-CoV-2 RT-PCR at screening or a positive SARS-CoV-2 rapid antigen test at Visit 2.
  • History of SARS-CoV-2 infection or COVID-19 within 3 months before randomization, per volunteer self-report.
  • History of significant local or systemic hypersensitivity to vaccines, including mRNA vaccines or excipients (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis, or ulceration) at any time.
  • History of splenectomy at any time. v. Ongoing or history of immunodeficiency or autoimmune disease at any time (not excluded: mild psoriasis that does not require ongoing systemic treatment).
  • Ongoing or history of myocarditis or pericarditis at any time vii. Ongoing or history of malignancy that, in the judgement of the investigator, has potential for recurrence (excluding basal cell carcinoma).
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  • Ongoing or history of seizures requiring medication (not excluded: febrile seizures before the age of 5 or seizures secondary to alcohol withdrawal more than 3 years ago).
  • Ongoing suicidal thoughts or history of suicide attempt in the last 3 years.
  • Ongoing or history of clinically significant substance or alcohol abuse in the last 3 years.
  • History of blood transfusion in the last 6 months. xii. Ongoing or history of bleeding disorder diagnosed by a healthcare provider (e.g., factor deficiency or coagulopathy).
  • Ongoing or history of infections requiring antibiotic, antiviral or antifungal therapy in the last 1 month.
  • Ongoing or history of any other clinically relevant medical condition, including serious psychiatric disorders, that in the judgement of the investigator or designee makes the participant unsuitable for participation in the study.
  • Vaccines. The participant has:
  • Received a COVID-19 vaccine other than 2 or 3 doses of an authorized or approved mRNA COVID-19 vaccine.
  • Received only 1 dose of an authorized mRNA vaccine. iii. Received a fourth dose (i.e., more than one booster) of a COVID-19 vaccine.
  • Received any vaccine in the last 28 days or plans to receive any vaccine in the 6 months after the booster vaccine administration, with the exception of subunit influenza vaccines, which may be administered ≥ 7 days after study vaccine administration.
  • Medications. The participant has:
  • Ongoing or history of use of immunosuppressive medications in the last 6 months.
  • Ongoing or history of use of systemic corticosteroids in the last 2 months (use of topical or inhaled steroids is permitted).
  • Ongoing or history of intake of any other medication that in the judgement of the investigator or designee makes the participant unsuitable for participation in the study.
  • The participant is lactating, pregnant or planning a pregnancy in the 12 months after randomization.
  • Laboratory tests. The participant has any of the following test results at screening:
  • Positive test for HIV-1, HIV-2, hepatitis B, hepatitis C. ii. Haemoglobin ≤ 10.5 g/dl or ≤ 6.5 mmol/L in volunteers assigned female sex at birth; ≤ 11.0 g/dl or ≤ 6.8 mmol/L in volunteers assigned male sex at birth.
  • Leukocyte (WBC) count ≥ 12,000 cells/mm3 OR ≤ 3,000 cells/mm3 iv. Platelet count ≤ 125,000 cells/mm3 or ≤ 125 × 109 cells/L. v. Creatinine ≥ 1.1 × upper limit of normal (ULN). vi. Alanine transaminase (ALT) ≥ 1.25 × ULN.
  • The participant is enrolled in another interventional clinical trial or was enrolled in the last 3 months or plans to participate during this study (concurrent participation in an observational study not requiring blood or tissue sample collection is allowed).
  • In the judgement of the investigator or designee it is not in the best interest of the participant to participate in the study.

About this study

Official title: A Phase I/II Partially Randomized, Active-controlled Observer-blind, Dose-selection, Safety and Immunogenicity Study of GLB-COV2-043, an mRNA Vaccine Candidate Against SARS-CoV-2, Administered as a Single-vaccination Booster to Previously Vaccinated Adults

The scope of this Phase I/II study is to determine whether GLB-COV2-043 is a promising booster vaccine candidate component for adult participants who have received the 2-dose priming course of the mRNA BNT162b2 vaccine against COVID-19, or the 2-dose priming course and a third BNT162b2 injection (i.e., as a "booster"), and, if so, to select the booster dose for further evaluation and potential development.

Conditions
COVID-19
Being tested
GLB-COV2-043, BNT162b2/COMIRNATY®
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLB-COV2-043Drug

    COVID-19 vaccine, administered as a booster

  • BNT162b2/COMIRNATY®Drug

    active control

Study groups in NCT05602961
Study groupRoleWhat they receive
Cohort 1 (includes GLB-COV2-043 15 μg)Experimental12 eligible adult participants will be randomized to 15 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
Receives: Drug: GLB-COV2-043; Drug: BNT162b2/COMIRNATY®
Cohort 2 (includes GLB-COV2-043 30 μg)Experimental12 eligible adult participants will be randomized to 30 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
Receives: Drug: GLB-COV2-043; Drug: BNT162b2/COMIRNATY®
Cohort 3 (includes GLB-COV2-043 60 μg)Experimental12 eligible adult participants will be randomized to 60 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
Receives: Drug: GLB-COV2-043; Drug: BNT162b2/COMIRNATY®
Cohort 4 (includes GLB-COV2-043 90 μg)Experimental12 eligible adult participants will be randomized to 90 ug of GLB-COV2-043 or to 30 ug of BNT162b2/COMIRNATY®, active control with a 5:1 allocation ratio.
Receives: Drug: GLB-COV2-043; Drug: BNT162b2/COMIRNATY®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety, including reactogenicity

    • Proportion of participants experiencing severe (Grade ≥ 3) solicited treatment emergent AEs
    • Proportion of participants with severe (Grade ≥ 3) non-serious unsolicited treatment emergent AEs
    • Proportion of participants with serious unsolicited treatment emergent AEs (SAEs)

    Measured: Day 0 to Day 28 post-vaccination

  2. Immunogenicity- neutralizing antibody response

    Geometric mean titre (GMT) and geometric mean ratios (GMR) relative to baseline of neutralizing IgG antibodies against the spike (S) protein of the SARS-CoV-2 Wuhan strain

    Measured: Day 0 to Day 28 post-vaccination

Secondary outcomes (5)

  1. Safety, including reactogenicity

    • Proportion of participants experiencing solicited treatment emergent AEs
    • Proportion of participants experiencing unsolicited treatment emergent AEs
    • Proportion of participants experiencing AEs of special interest (AESI), AEs requiring unscheduled medical attendance (MAAEs) or Serious AEs (SAEs)

    Measured: Day 0 to Day 168 post-vaccination

  2. Antibody-mediated immunogenicity titers (GMT)

    Serum neutralizing IgG antibodies and binding IgG antibodies against the spike (S) protein of the original (wild) Wuhan strain, Omicron Variant of Concern (VoC), Delta VoC, Beta VoC, and Gamma VoC assessed as geometric mean titres (GMT), geometric mean ratio (GMR, fold increase from baseline) and percentage of sero-responders

    Measured: baseline (Week 0) and 4, 24 and 52 weeks (7, 28, 168 and 365 days) post-vaccination

  3. Antibody-mediated immunogenicity fold-increase (GMR)

    Serum neutralizing IgG antibodies and binding IgG antibodies against the spike (S) protein of the original (wild) Wuhan strain, Omicron Variant of Concern (VoC), Delta VoC, Beta VoC, and Gamma VoC assessed as geometric mean ratio (GMR, fold increase from baseline) and percentage of sero-responders

    Measured: baseline (Week 0) and 4, 24 and 52 weeks (7, 28, 168 and 365 days) post-vaccination

  4. Antibody-mediated immunogenicity response rate

    Serum neutralizing IgG antibodies and binding IgG antibodies against the spike (S) protein of the original (wild) Wuhan strain, Omicron Variant of Concern (VoC), Delta VoC, Beta VoC, and Gamma VoC assessed as percentage of sero-responders

    Measured: baseline (Week 0) and 4, 24 and 52 weeks (7, 28, 168 and 365 days) post-vaccination

  5. Cell-mediated immunogenicity

    Intracellular cytokine staining (ICS) of antigen specific CD4+ and CD8+ T-cells against the original (wild) Wuhan strain, Omicron VoC and Delta VoC assessed as frequency of total antigen-specific CD4+ and CD8+ T-cells producing IFN-gamma, TNF-alpha or IL-2

    Measured: 4 and 24 weeks (28 and 168 days) post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2022
  2. Study start21 Feb 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Why it stopped: to prioritize other programs.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05602961
Sponsor's protocol ID
GLB-003
Status last verified
Aug 2023
First submitted
28 Oct 2022
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GLB-COV2-043 and BNT162b2/COMIRNATY® in people with COVID-19, run by GreenLight Biosciences, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety, including reactogenicity (time frame: Day 0 to Day 28 post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05602961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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