Key result
Angiotensin II vaccine AGMG0201 demonstrates safety with zero severe adverse events in essential hypertension.
Why the study?
An angiotensin II vaccine for hypertension was developed and its safety, tolerability, and immunological responses needed investigation in patients with mild to moderate hypertension.
Does AGMG0201 (angiotensin II vaccine) safely induce an immune response in patients with mild to moderate essential hypertension?
RCT (n=24)
Double-blind
3:1 (active to placebo)
Does AGMG0201 (angiotensin II vaccine) safely induce an immune response in patients with mild to moderate essential hypertension?
The angiotensin II vaccine AGMG0201 appears safe, well-tolerated, and immunogenic in patients with mild to moderate hypertension in a phase I/IIa study.
AGMG0201 was well tolerated with antibody induction; leaves open efficacy on blood pressure and need for larger trials.
We have been developing an angiotensin II vaccine for hypertension. We conducted a placebo-controlled dose escalation study to investigate the safety, tolerability, and immunological responses of this angiotensin II vaccine (AGMG0201). AGMG0201 was administered to participants with mild to moderate hypertension between 18 and 79 years of age. Twelve patients each were enrolled in the low-dose and high-dose groups. Within each group, subjects were randomly assigned to receive either the active study drug or a placebo at a ratio of 3:1. Each participant received a single intramuscular injection, followed by a second injection 30 days later, and was monitored for 360 days after the second dose. The results showed that most treatment-related adverse events were classified as mild or moderate in severity, including pain and erythema at the injection site. Anti-angiotensin II antibodies were observed in the AGMG0201 patients, especially in the high-dose group. Overall, AGMG0201 was well tolerated.
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Nakagami et al. (2021) conducted an RCT in Mild to moderate essential hypertension (n=24). AGMG0201 (angiotensin II DNA vaccine) vs. Placebo (saline) was evaluated on Solicited and unsolicited adverse events up to 90 days after vaccination. AGMG0201 was well tolerated in patients with mild to moderate essential hypertension, with no severe adverse events and most treatment-related adverse events classified as mild or moderate.
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