Sept. 28, 2021 |
|
Aug. 20, 2023 |
|
jRCT2051210093 |
A Phase I/II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of MT-2766 in Japanese Adults (COVID-19) |
|
Safety immunogenicity study of MT-2766 in Japanese adults (COVID-19) |
Jan. 29, 2023 |
|
128 |
|
The mean +/- SD age of subjects at the time of informed consent was 46.9+/- 11.2 years in the MT-2766 group and 46.8+/- 11.9 years in the placebo group. All subjects were Japanese. The mean +/- SD BMI was 22.84 +/- 2.68 kg/m^2 in the MT-2766 group and 23.08+/- 3.06 kg/m^2 in the placebo group. Men were 64.0% (64/100) in the MT-2766 group and 42.3% (11/26) in the placebo group. |
|
Of the 128 randomized subjects, 102 subjects were randomized to the MT-2766 group and 26 subjects were randomized to the placebo group. Of these, 127 subjects (101 subjects in the MT-2766 group and 26 subjects in the placebo group) received at least 1 dose of investigational product. There were 2 subjects (both in the MT-2766 group) who discontinued the study from randomization to Day 42, 1 subject due to withdrawal by subject and 1 subject due to lost to follow-up. A total of 126 subjects (100 subjects in the MT-2766 group and 26 subjects in the placebo group) discontinued the study after Day 43: 14 subjects (6 subjects in the MT-2766 group and 8 subjects in the placebo group) due to public vaccination, 3 subjects (1 subject in the MT-2766 group and 2 subjects in the placebo group) due to withdrawal by subject, 3 subjects (all in the MT-2766 group) due to Physician decision, 1 subject (MT-2766 group) due to lost to follow-up, 1 subject (MT-2766 group) due to other reasons, and 104 subjects (88 subjects in the MT-2766 group and 16 subjects in the placebo group) due to study terminated by Sponsor.. |
|
The most frequently reported adverse events were pain {83.2% (84/101 subjects) in the MT-2766 group, 11.5% (3/26 subjects) in the placebo group}, fatigue {49.5% (50/101 subjects) in the MT-2766 group, 23.1% (6/26 subjects) in the placebo group}, headache {46.5% (47/101 subjects) in the MT-2766 group, 19.2% (5/26 subjects) in the placebo group}, chills {43.6% (44/101 subjects) in the MT-2766 group, 3.8% (1/26 subjects) in the placebo group}, muscle aches {43.6% (44/101 subjects) in the MT-2766 group, 0% (0/26 subjects) in the placebo group}, feeling of general discomfort {38.6% (39/101 subjects) in the MT-2766 group, 19.2% (5/26 subjects) in the placebo group}, induration {35.6% (36/101 subjects) in the MT-2766 group, 0% (0/26 subjects) in the placebo group}, swelling {29.7% (30/101 subjects) in the MT-2766 group, 0% (0/26 subjects) in the placebo group}, joint aches {27.7% (28/101 subjects) in the MT-2766 group, 3.8% (1/26 subjects) in the placebo group}, fever {14.9% (15/101 subjects) in the MT-2766 group, 0% (0/26 subjects) in the placebo group}, redness {11.9% (12/101 subjects) in the MT-2766 group, 0% (0/26 subjects) in the placebo group}, and feeling of swelling in the neck {8.9% (9/101 subjects) in the MT-2766 group, 3.8% (1/26 subjects) in the placebo group}. Serious adverse events were reported in 2 subjects (one subject each with cerebral infarction, and large intestine polyp) in the MT-2766 group and 2 subjects (one subject each with COVID-19, and sternal fracture) in the placebo group. There were no adverse events leading to study withdrawa and/or death. |
|
Neutralizing antibody GMT (95% CI) on Day 21 and Day 42 were 43.9 (31.9, 60.3) and 912.6(733.6, 1135.1), respectively, in the MT-2766 group and 7.0 (4.3, 11.5) and 7.0 (4.5,11.0), respectively, in the placebo group. Seroconversion rates (95% CI) on Day 21 and Day 42 were 38.9% (29.1, 49.5) and 99.0% (94.4, 100.0), respectively, in the MT-2766 group and 0% (0.0, 13.7) and 0% (0.0, 13.7), respectively, in the placebo group. GMFR (95% CI) on Day 21 and Day 42 were 6.55 (5.20, 8.26) and 136.75 (112.15, 166.74) in the MT-2766 group and 1.03 (0.66, 1.62) and 1.04 (0.71, 1.54) in the placebo group, respectively. GMT, seroconversion rate, and GMFR were higher in the MT-2766 group than in the placebo group at all time points. Specific Th1 cell-mediated immune responses were assessed by the number of IFN-gamma secreting cells using ELISpot assay. The median (95% CI) number of IFN-gamma secreting cells (SFC/10^6 PBMC) on Day 21 and Day 42 was 330.0 (233.0, 465.0) and 1173.0 (1010.0, 1305.0), respectively, in the MT-2766 group and 265.5 (128.0, 635.0) and 413.0 (43.0, 835.0), respectively, in the placebo group, showing a higher number in the MT-2766 group than in the placebo group on Day 42. Specific Th2 cell-mediated immune responses were assessed by the number of IL-4 secreting cells using ELISpot assay. The median (95% CI) number of IL-4 secreting cells (SFC/10^6 PBMC) on Day 21 and Day 42 was 0.0 (0.0, 75.0) and 619.0 (540.0, 786.0), respectively, in the MT-2766 group and 0.0 (0.0, 0.0) and 0.0 (0.0, 0.0), respectively, in the placebo group, being higher in the MT-2766 group than in the placebo group on Day 42. Specific antibody responses (GMT, seroconversion rate, and GMFR of Total IgG) were higher in the MT-2766 group than in the placebo group on Day 21, Day 42, Day 128, and Day 201. |
|
Neutralizing antibody (Nab) response, Specific Th1 cell-mediated immune (CMI) and Specific Th2 CMI responses were higher in the MT-2766 group than in the placebo group on Day 42. Nab response, specific Th1 and specific Th2 CMI response through Day 201 were higher in the MT-2766 group compared to the placebo group despite decreasing over time compared to Day 42, suggesting persistence of Nab response and specific Th1 and Th2 CMI response. There were no significant safety concerns in this study. |
|
Aug. 20, 2023 |
|
No |
|
https://jrct.niph.go.jp/latest-detail/jRCT2051210093 |
Kondo Kazuoki |
||
Mitsubishi Tanabe Pharma Corporation |
||
1-1-1, Marunouchi, Chiyoda-ku, Tokyo |
||
+81-3-5960-9608 |
||
cti-inq-ml@ml.mt-pharma.co.jp |
||
Information Desk Clinical Trials |
||
Mitsubishi Tanabe Pharma Corporation |
||
1-1-1, Marunouchi, Chiyoda-ku, Tokyo |
||
+81-3-5960-9608 |
||
cti-inq-ml@ml.mt-pharma.co.jp |
Complete |
Oct. 02, 2021 |
||
Oct. 02, 2021 | ||
145 | ||
Interventional |
||
randomized controlled trial |
||
double blind |
||
placebo control |
||
parallel assignment |
||
prevention purpose |
||
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 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: |
||
20age old over | ||
No limit | ||
Both |
||
COVID-19 |
||
Two doses (Day 0 and Day 21) of MT-2766 (including CoVLP and AS03) High dose, MT-2766 (including CoVLP and AS03) Low dose or Placebo. |
||
Safety: |
||
Safety: |
Medicago R&D Inc. |
Medical Corporation Heishinkai OPHAC Hospital IRB | |
4-1-29 Miyahara,Yodogawa-ku,Osaka-shi, Osaka | |
+81-6-6395-9000 |
|
ophach_irb@heishinkai.com | |
Approval | |
NCT05065619 | |
ClinicalTrials.gov |
none |