Safety Immunogenicity Study of MT-2766 in Japanese Adults（COVID-19）

NCT05065619 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: MT-2766-A-101/CP-PRO-CoVLP-028jRCT2051210093
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to evaluate the safety and immunogenicity of MT-2766 in Japanese adults.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality

  Immediate AEs are defined as any solicited AEs and unsolicited AEs occurring within 30 minutes after vaccination. The causal relationship of all solicited AEs to investigational product was analyzed as related.

  Within 30 minutes after each vaccination

• Percentage of Participants With Solicited AEs According to Severity

  Solicited AEs are defined the following; (i) local AEs (injection site erythema, injection site swelling, injection site induration, and injection site pain) and (ii) systemic AEs (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck)．

  Within 7 days after each vaccination

• Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality

  Within 21 days after each vaccination

• Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths

  AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases

  Within 21 days after each vaccination

• SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT

  Geometric mean neutralizing antibody titer (GMT)

  Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)

• SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR

  Geometric mean fold rise (GMFR) is defined as the ratio of geometric mean antibody titer (GMT) based on that of Day 0 (i.e. Day 21/Day 0 and Day 42/Day 0).

  Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)

• SARS-CoV-2 Neutralizing Antibody (Nab) Responses

  Seroconversion (SC) rate. SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with: * For subjects with detectable Nab titer at Day 0 (i.e. baseline Nab titer ≥10): a ≥ 4-fold increase in Nab titers between Day 0 and Day 21/42, respectively. * For subjects with undetectable Nab titer at Day 0 (i.e. baseline Nab titer \< 10): Nab titer of ≥ 40 on Day 21/42, respectively.

  Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)

• SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses

  Using the interferon-γ enzyme-linked immunospot (ELISpot) assay. Unit of Measure: Spot-Forming Cell (SFC)/10\^6 Peripheral Blood Mononuclear Cells (PBMC)

  Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)

• SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses

  Using the interleukin-4 ELISpot assay

  Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)

Secondary Outcomes (9)

• Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths

  Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.

• SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT

  Day 128 and Day 201

• SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR

  Day 128 and Day 201

• Seroconversion (SC) Rate of SARS-CoV-2 Neutralizing Antibody

  Day 128 and Day 201

• SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses

  Days 201

Study Arms (3)

MT-2766 High dose (3.75 µg)

EXPERIMENTAL

Biological: MT-2766 High dose (3.75 µg)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

MT-2766 Low dose

EXPERIMENTAL

Biological: MT-2766 Low dose

Interventions

MT-2766 High dose (3.75 µg) BIOLOGICAL

Subjects will receive two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)

Also known as: CoVLP, AS03 adjuvant

MT-2766 High dose (3.75 µg)

Placebo DRUG

Subjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)

Placebo

MT-2766 Low dose BIOLOGICAL

Subjects will receive two doses of MT-2766 low dose given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)

Also known as: CoVLP, AS03 adjuvant

MT-2766 Low dose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and must communicate with the study staff at visits and by phone during the study;
• At the Screening visit (Visit 1), Japanese male and female subjects must be ≥20 years of age;
• At the Screening visit (Visit 1) and 1st vaccination visit (Visit 2), subject must have a body mass index (BMI) of ≥18.5 kg/m\^2 and \<30 kg/m\^2;
• Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
• Female subjects of childbearing potential must have a negative serum pregnancy test result at the Screening visit (Visit 1) and a negative urine pregnancy test result at 1st vaccination visit (Visit 2):
• Non-childbearing females are defined as:
• Surgically sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to the first study vaccination); OR
• Post-menopausal (absence of menses for 12 consecutive months and age consistent with natural cessation of ovulation);
• Female subjects of childbearing potential must use an effective method of contraception for one month prior to 1st vaccination visit (Visit 2) and agree to continue employing highly effective birth control measures for at least one month after the last study vaccination (or in the case of early termination, she must not plan to become pregnant for at least one month after her last study vaccination);
• Subjects must be non-institutionalized (e.g. not living in rehabilitation centers or old-age homes);

You may not qualify if:

• According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness.
• Acute disease is defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2).
• 'Uncontrolled' is defined as:
• Requiring a new medical or surgical treatment during the three months prior to study vaccine administration;
• Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month prior to the 1st vaccination visit (Visit 2). Inhaled, nasal, ophthalmic, dermatological, and other topical glucocorticoids are permitted;
• Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to 1st vaccination visit (Visit 2);

Sponsors & Collaborators

• Medicago: lead
• Tanabe Pharma Corporation: collaborator

Study Sites (3)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

MeSH Terms

Conditions

COVID-19

Interventions

MT-2766 vaccine; AS03 adjuvant

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

Results Point of Contact

• Title: Medical Director
• Organization: Medicago

clinicaltrialinquiries@medicago.com

+1 418-658-9393

Study Officials

• Medical Director

  Medicago

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: MT-2766 High dose group and placebo group are randomized and observer-blinded. MT-2766 Low dose group is open label.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 4, 2021
• Study Start: October 2, 2021
• Primary Completion: March 12, 2022
• Study Completion: January 29, 2023
• Last Updated: November 7, 2023
• Results First Posted: May 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)