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

NCT05602961 | Withdrawn Phase 1 DMC

• 1 other identifier: GLB-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 "booster"), and, if so, to select the booster dose for further evaluation and potential development.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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)

  Day 0 to Day 28 post-vaccination

• 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

  Day 0 to Day 28 post-vaccination

Secondary Outcomes (5)

• Safety, including reactogenicity

  Day 0 to Day 168 post-vaccination

• Antibody-mediated immunogenicity titers (GMT)

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

• Antibody-mediated immunogenicity fold-increase (GMR)

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

• Antibody-mediated immunogenicity response rate

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

• Cell-mediated immunogenicity

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

Study Arms (4)

Cohort 1 (includes GLB-COV2-043 15 μg)

EXPERIMENTAL

12 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.

Drug: GLB-COV2-043; Drug: BNT162b2/COMIRNATY®

Cohort 2 (includes GLB-COV2-043 30 μg)

EXPERIMENTAL

12 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.

Drug: GLB-COV2-043; Drug: BNT162b2/COMIRNATY®

Cohort 3 (includes GLB-COV2-043 60 μg)

EXPERIMENTAL

12 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.

Drug: GLB-COV2-043; Drug: BNT162b2/COMIRNATY®

Cohort 4 (includes GLB-COV2-043 90 μg)

EXPERIMENTAL

12 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.

Drug: GLB-COV2-043; Drug: BNT162b2/COMIRNATY®

Interventions

GLB-COV2-043 DRUG

COVID-19 vaccine, administered as a booster

Cohort 1 (includes GLB-COV2-043 15 μg); Cohort 2 (includes GLB-COV2-043 30 μg); Cohort 3 (includes GLB-COV2-043 60 μg); Cohort 4 (includes GLB-COV2-043 90 μg)

BNT162b2/COMIRNATY® DRUG

active control

Cohort 1 (includes GLB-COV2-043 15 μg); Cohort 2 (includes GLB-COV2-043 30 μg); Cohort 3 (includes GLB-COV2-043 60 μg); Cohort 4 (includes GLB-COV2-043 90 μg)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Medical conditions. The participant has:
• i. 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.
• ii. History of SARS-CoV-2 infection or COVID-19 within 3 months before randomization, per volunteer self-report.
• iii. 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.
• iv. 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).
• vi. 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).
• viii. 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).
• ix. Ongoing suicidal thoughts or history of suicide attempt in the last 3 years.
• x. Ongoing or history of clinically significant substance or alcohol abuse in the last 3 years.
• xi. 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).
• xiii. Ongoing or history of infections requiring antibiotic, antiviral or antifungal therapy in the last 1 month.
• xiv. 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:
• i. Received a COVID-19 vaccine other than 2 or 3 doses of an authorized or approved mRNA COVID-19 vaccine.
• ii. 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.

Sponsors & Collaborators

• GreenLight Biosciences, Inc.: lead

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 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

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

Study Officials

• Shelly Karuna, MD, MPH

  GreenLight Biosciences

  STUDY DIRECTOR

• Etienne Karita, MD, MSc, MSPH

  Center for Family Health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 2, 2022
• Study Start: February 21, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08