Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9838 · 1 trial · 2 indications
Immediate unsolicited AEs were defined as having an onset within 30 minutes post vaccination.
Injection site solicited ARs included injection site pain, injection site erythema (redness), and injection site swelling. Systemic solicited ARs included fever, chills, headache, myalgia (muscle aches and pains), and fatigue (physical or mental tiredness).
Unsolicited AEs were any AEs reported in addition to predefined solicited ARs.
An SAE is an AE meeting one or more of: resulted in death; was immediately life-threatening; required or prolonged in-patient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or was an important medical event that may have jeopardized the participant or required intervention to prevent the above. MAAEs are AEs leading to medically attended visits that were not routine physical examination or vaccination visits (eg, urgent care, emergency room, or unscheduled visits to/from medical personnel, including telemedicine). An AESI was an event of scientific and medical interest, specific to understanding the safety profile of the investigational vaccine, requiring close monitoring and rapid communication by Investigators to the Sponsor.
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 ancestral strain neutralizing antibodies
Model-adjusted GMTs and 95% CIs for SARS-CoV-2 Omicron BA.4/5 neutralizing antibodies
Model-adjusted GMTs and 95% CIs 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
Seroresponse was defined as GMFR \>=4 from baseline
Seroresponse was defined as GMFR \>=4 from baseline
Seroresponse was defined as GMFR \>=4 from baseline
| Arm | Type | Description |
|---|---|---|
| AZ BA.4/5 5µg, 18-64 years | EXPERIMENTAL | Participants received a single intramuscular dose of AZD9838. |
| AZ BA.4/5 10µg, 18-64 years | EXPERIMENTAL | Participants received a single intramuscular dose of AZD9838. |
| Pfizer XBB.1.5, 18-64 years | ACTIVE_COMPARATOR | Participants received a single intramuscular dose of the Pfizer XBB.1.5 vaccine. |
| AZ XBB.1.5 5µg, 18-64 years | EXPERIMENTAL | Participants received a single intramuscular dose of AZD6563. |
| AZ XBB.1.5 10µg, 18-64 years | EXPERIMENTAL | Participants received a single intramuscular dose of AZD6563. |
| AZ XBB.1.5 5µg, >=65 years | EXPERIMENTAL | Participants received a single intramuscular dose of AZD6563. |
| AZ XBB.1.5 10µg, >=65 years | EXPERIMENTAL | Participants received a single intramuscular dose of AZD6563. |
| Pfizer XBB.1.5, >=65 years | ACTIVE_COMPARATOR | Participants received a single intramuscular dose of the Pfizer XBB.1.5 vaccine. |
| Name | Type | Description |
|---|---|---|
| AZD9838 | BIOLOGICAL | Intramuscular (IM) injection. |
| Licensed SARS-CoV-2 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...
AZD9838 is a monoclonal antibody being developed for COVID-19, specifically for the prevention or treatment of SARS-CoV-2 infection. It is currently in Phase 1 clinical development as an investigational therapy for this infectious disease indication.
AZD9838 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and immunogenicity of this monoclonal antibody for COVID-19.
AZD9838 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to assess its safety and immunogenicity in healthy volunteers for COVID-19.
AZD9838 has been evaluated in one clinical trial with the identifier NCT06147063. This was a randomized, active-controlled Phase 1 study that assessed the immunogenicity and safety of a mRNA-VLP vaccine for COVID-19. The trial enrolled 243 participants in the United States and has been completed.
AZD9838 is a monoclonal antibody, not a vaccine. The clinical trial NCT06147063 evaluated a mRNA-VLP vaccine's immunogenicity and safety for COVID-19, but the drug itself is a monoclonal antibody. The trial was active-controlled, meaning it compared the vaccine against an active control.