SARS-CoV-2 InfectionPhase 1/2NCT05065619
Safety Immunogenicity Study of MT-2766 in Japanese Adults（COVID-19）
A Phase 1/2 study testing MT-2766 High dose (3.75 µg) and MT-2766 Low dose in people with SARS-CoV-2 Infection, run by Medicago at 3 sites in Japan.
Trial summary
The objective of this study is to evaluate the safety and immunogenicity of MT-2766 in Japanese adults. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- MT-2766 High dose (3.75 µg) and MT-2766 Low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 3 sitesJapan
- Study dates
- 2 Oct 2021to 29 Jan 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria at the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2) to be eligible for participation in this study. All Investigator assessment-based judgments must be carefully and fully documented in the source documents:
- 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):
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- 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);
- Subjects have no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, serology, clinical chemistry and hematology tests, urinalysis, and vital signs. Investigator discretion is permitted with this inclusion criterion.
Who cannot join
- Subjects who meet any of the following exclusion criteria at the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2) will not be eligible for participation in this study. All Investigator assessment-based judgments must be carefully and fully documented in the source documents:
- 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;
- Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 8 and is appropriately justified by the Investigator.
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- Investigator discretion is permitted with this exclusion criterion. 2. Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, HIV, hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion; 3. Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis). Investigator discretion is permitted with this exclusion criterion. Subjects may be eligible to participate with appropriate written justification in the source document. For example, subjects with a history of autoimmune disease who are disease-free without treatment for three years or more, subjects receiving stable thyroid replacement therapy, and subjects with mild psoriasis (i.e. a small number of minor plaques requiring no systemic treatment) are eligible for participation; 4. Administration of any medication or treatment that may alter the vaccine immune responses, such as:
- 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);
- Any immunoglobulin preparations, blood products, or blood transfusion - within 6 months prior to 1st vaccination visit (Visit 2); 5. Administration of any vaccine within 14 days prior to 1st vaccination visit (Visit 2); planned administration of any vaccine during the study (up to Day 28). Immunization on an emergency basis during the study will be evaluated on case-by-case basis by the Investigator; 6. Administration of any other SARS-CoV-2/COVID-19 vaccine, or other experimental coronavirus vaccine at any time prior to or during the study; 7. At screening (Visit 1), subjects found to be seropositive for prior SARS-COV-2 infection based on N-protein ELISA or positive for SARS-COV-2 PCR test; 8. Subjects with previous diagnosis of COVID-19 or previous positive SARS-CoV-2 infection 9. Use of any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, prior to 1st vaccination visit (Visit 2), or planned use during the study period. Subjects who are in a prolonged post-administration observation period of another investigational or marketed drug clinical study, for which there is no ongoing exposure to the investigational or marketed product and all scheduled on-site visits are completed, will be allowed to take part in this study, if all other eligibility criteria are met; 10. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at injection site that may interfere with injection site reaction rating. Investigator discretion is permitted with this exclusion criterion: 11. Use of any prescription antiviral drugs with the intention of COVID-19 prophylaxis, including those that are thought to be effective for prevention of COVID-19 but have not been licensed for this indication, within one month prior to 1st vaccination visit (Visit 2); 12. Use of prophylactic medications (e.g. antihistamines [H1 receptor antagonists], nonsteroidal anti-inflammatory drugs [NSAIDs], systemic and topical glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the 1st vaccination (Visit 2) to prevent or pre-empt symptoms due to vaccination; 13. History of a serious allergic response to any of the constituents of MT-2766; 14. History of a documented anaphylactic reactions to plants or plant components (including tobacco, fruits, and nuts); 15. Personal or family (first-degree relatives) history of narcolepsy; 16. Subjects with a history of Guillain-Barré Syndrome; 17. Any female subject who has a definitely or possibly positive pregnancy test result prior to vaccination or who is lactating; 18. As a result of the medical screening process, the Investigator considers the subject not suitable for the study.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853
About this study
Official title: A Phase I/II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of MT-2766 in Japanese Adults (COVID-19)
The objective of this study is to evaluate the safety and immunogenicity of MT-2766 in Japanese adults.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- MT-2766 High dose (3.75 µg), Placebo, MT-2766 Low dose
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-2766 High dose (3.75 µg)Biological
Also called CoVLP, AS03 adjuvant
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)
PlaceboDrug
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)
MT-2766 Low doseBiological
Also called CoVLP, AS03 adjuvant
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)
| Study group | Role | What they receive |
|---|---|---|
| MT-2766 High dose (3.75 µg) | Experimental | Not described Receives: Biological: MT-2766 High dose (3.75 µg) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| MT-2766 Low dose | Experimental | Not described Receives: Biological: MT-2766 Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)．
Measured: Within 7 days after each vaccination
Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality
Measured: 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
Measured: Within 21 days after each vaccination
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT
Geometric mean neutralizing antibody titer (GMT)
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases.
Measured: 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
Geometric mean neutralizing antibody titer (GMT)
Measured: Day 128 and Day 201
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR
Geometric mean fold rise (GMFR)
Measured: Day 128 and Day 201
Seroconversion (SC) Rate of SARS-CoV-2 Neutralizing Antibody
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 128/201, respectively.
- For subjects with undetectable Nab titer at Day 0 (i.e. baseline Nab titer < 10): Nab titer of ≥ 40 on Day 128/201, respectively.
Measured: Day 128 and Day 201
SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses
Using the interferon-γ enzyme-linked immunospot (ELISpot) assay.
Measured: Days 201
SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses
Using the interleukin-4 ELISpot assay
Measured: Days 201
SARS-CoV-2-specific Antibody Responses (Total IgG): GMT
Geometric mean neutralizing antibody titer (GMT)
Measured: Day 0，Day 21，Day 42，Day 128 and Day 201
SARS-CoV-2-specific Antibody Responses (Total IgG): GMFR
Geometric mean fold rise (GMFR)
Measured: Day 0，Day 21，Day 42，Day 128 and Day 201
Seroconversion (SC) Rate of SARS-CoV-2-specific Antibody Responses (Total IgG):
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 21/42/128/201, 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.
Measured: Day 0，Day 21，Day 42，Day 128 and Day 201
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start2 Oct 2021
- Primary completion12 Mar 2022
- Study completion29 Jan 2023
Why it stopped: Public vaccination of approved ancestral strain COVID-19 vaccines will be terminated soon. And boosters must be dosed after ancestral vaccination approved in Japan. The study was terminated for ethical reason to prioritize the ancestral vaccination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicago
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tanabe Pharma Corporation
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Medicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065619
- Sponsor's protocol ID
- MT-2766-A-101/CP-PRO-CoVLP-028
- Other IDs
- jRCT2051210093
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2021
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of MT-2766 in Japanese Adults (COVID-19)
- ClinicalTrials.gov ID
- NCT05065619
- Acronym / sponsor ID
- MT-2766-A-101/CP-PRO-CoVLP-028
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Public vaccination of approved ancestral strain COVID-19 vaccines will be terminated soon. And boosters must be dosed after ancestral vaccination approved in Japan. The study was terminated for ethical reason to prioritize the ancestral vaccination.
- Enrolment
- 128 participants (actual)
- Lead sponsor
- MedicagoIndustry (pharma, biotech, devices)
- Collaborators
- Tanabe Pharma Corporation
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 29 Jan 2023 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Posted 1 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and immunogenicity of MT-2766 in Japanese adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must meet all of the following inclusion criteria at the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2) to be eligible for participation in this study. All Investigator assessment-based judgments must be carefully and fully documented in the source documents:
- 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;
Key exclusion criteria (10 listed)
- Subjects who meet any of the following exclusion criteria at the Screening visit (Visit 1) and/or 1st vaccination visit (Visit 2) will not be eligible for participation in this study. All Investigator assessment-based judgments must be carefully and fully documented in the source documents:
- 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).
- Requiring a new medical or surgical treatment during the three months prior to study vaccine administration;
- Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 8 and is appropriately justified by the Investigator.
- Investigator discretion is permitted with this exclusion criterion. 2. Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, HIV, hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion; 3. Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis). Investigator discretion is permitted with this exclusion criterion. Subjects may be eligible to participate with appropriate written justification in the source document. For example, subjects with a history of autoimmune disease who are disease-free without treatment for three years or more, subjects receiving stable thyroid replacement therapy, and subjects with mild psoriasis (i.e. a small number of minor plaques requiring no systemic treatment) are eligible for participation; 4. Administration of any medication or treatment that may alter the vaccine immune responses, such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-2766 High dose (3.75 µg)Also: CoVLP, AS03 adjuvantSubjects 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) | Biological | MT-2766 High dose (3.75 µg) |
| PlaceboSubjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once) | Drug | Placebo |
| MT-2766 Low doseAlso: CoVLP, AS03 adjuvantSubjects 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) | Biological | MT-2766 Low dose |
Primary outcome
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Time frame: Within 30 minutes after each vaccination
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.
Percentage of Participants With Solicited AEs According to Severity
Time frame: Within 7 days after each vaccination
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)．
Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality
Time frame: 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
Time frame: Within 21 days after each vaccination
AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT
Time frame: Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)
Geometric mean neutralizing antibody titer (GMT)
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR
Time frame: Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)
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).
SARS-CoV-2 Neutralizing Antibody (Nab) Responses
Time frame: Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)
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.
SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses
Time frame: Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)
Using the interferon-γ enzyme-linked immunospot (ELISpot) assay. Unit of Measure: Spot-Forming Cell (SFC)/10^6 Peripheral Blood Mononuclear Cells (PBMC)
SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses
Time frame: Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)
Using the interleukin-4 ELISpot assay
9 secondary outcomes
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Time frame: 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
Time frame: Day 128 and Day 201
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR
Time frame: Day 128 and Day 201
Seroconversion (SC) Rate of SARS-CoV-2 Neutralizing Antibody
Time frame: Day 128 and Day 201
SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses
Time frame: Days 201
SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses
Time frame: Days 201
SARS-CoV-2-specific Antibody Responses (Total IgG): GMT
Time frame: Day 0，Day 21，Day 42，Day 128 and Day 201
SARS-CoV-2-specific Antibody Responses (Total IgG): GMFR
Time frame: Day 0，Day 21，Day 42，Day 128 and Day 201
Seroconversion (SC) Rate of SARS-CoV-2-specific Antibody Responses (Total IgG):
Time frame: Day 0，Day 21，Day 42，Day 128 and Day 201
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Medicago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MT-2766 High dose (3.75 µg) and MT-2766 Low dose in people with SARS-CoV-2 Infection, run by Medicago at 3 sites in Japan.
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 12 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality (time frame: Within 30 minutes after each vaccination). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.