Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06147063 | A Randomized Trial Evaluating a mRNA-VLP Vaccine's Immunogenicity and Safety for COVID-19 | PHASE1 | COMPLETED | 243 | — | — | Nov 27, 2023 | Mar 27, 2025 | Jun 29, 2025 | 5 | United States |
Number of participants who experienced immediate unsolicited AEs within 30 minutes post vaccination.
Number of participants who experienced injection site and systemic solicited ARs through 7 days post vaccination.
Number of participants who experienced unsolicited AEs through 28 days post vaccination.
Number of participants who experienced SAEs through 12 months post vaccination.
Number of participants who experienced MAAEs through 12 months post vaccination.
Number of participants who experience AESIs through 12 months post vaccination.
GMT for SARS-CoV-2 ancestral strain neutralizing antibodies
GMT for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
GMT for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
GMFR for SARS-CoV-2 ancestral strain neutralizing antibodies
GMFR for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
GMFR for SARS-CoV-2 Omicron XBB.1.5 neutralizing antibodies
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 ancestral strain, defined as GMFR \>=4 from baseline
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron BA.4/5, defined as GMFR \>=4 from baseline
Proportion of participants with neutralizing antibody seroresponse against SARS-CoV-2 Omicron XBB.1.5, defined as GMFR \>=4 from baseline
| Arm | Type | Description |
|---|---|---|
| Arm 1: dosage 1 of AZD9838 18 to 64 years of age | EXPERIMENTAL | Participants will receive 1 intramuscular dose of AZD9838. |
| Arm 2: dosage 2 of AZD9838 18 to 64 years of age | EXPERIMENTAL | Participants will receive 1 intramuscular dose of AZD9838. |
| Arm 3: licensed mRNA vaccine 18 to 64 years of age | ACTIVE_COMPARATOR | Participants will receive 1 intramuscular dose of the licensed mRNA vaccine. |
| Arm 4: dosage 1 of AZD6563 18 to 64 years of age | EXPERIMENTAL | Participants will receive 1 intramuscular dose of AZD6563. |
| Arm 5: dosage 2 of AZD6563 18 to 64 years of age | EXPERIMENTAL | Participants will receive 1 intramuscular dose of AZD6563. |
| Arm 6: dosage 1 of AZD6563 65 years of age and older | EXPERIMENTAL | Participants will receive 1 intramuscular dose of AZD6563. |
| Arm 7: dosage 2 of AZD6563 65 years of age and older | EXPERIMENTAL | Participants will receive 1 intramuscular dose of AZD6563. |
| Arm 8: licensed mRNA vaccine 65 years of age and older | ACTIVE_COMPARATOR | Participants will receive 1 intramuscular dose of the licensed mRNA vaccine. |
| Name | Type | Description |
|---|---|---|
| AZD9838 | BIOLOGICAL | Intramuscular (IM) injection. |
| Licensed mRNA vaccine | BIOLOGICAL | Intramuscular (IM) injection. |
| AZD6563 | BIOLOGICAL | Intramuscular (IM) injection. |
Key Inclusion Criteria: * Adults ≥ 18 years at the time of signing informed consent. * Self-reported History of SARS-CoV-2 infection at least 6 months prior to study vaccination AND/OR prior completion of primary series vaccination against COVID-19, with the final dose received at least 6 months pr...