NCT00701649

A Double Blind, Randomized, Placebo Controlled, Parallel Group Phase IIa Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of an Anti-Angiotensin II Vaccine (CYT006-AngQb) in Patients With Mild to Moderate Essential Hypertension

Completed Phase 2 Last updated 1 December 2009

What this trial tests

Phase 2 trial testing CYT006-AngQb in Hypertension in 60 participants. Completed in 1 November 2009.

Timeline

1 March 2008

Primary endpoint
1 March 2009

1 November 2009

Quick facts

Lead sponsor	Cytos Biotechnology AG
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 March 2008
Primary completion	1 March 2009
Estimated completion	1 November 2009
Sites	6 locations across Germany, Switzerland

Drugs / interventions tested

• CYT006-AngQb — full drug profile →
• Placebo

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Cytos Biotechnology AG — full company profile →

Who can join

Adults 18 to 69, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Adverse events: quality, quantity, severity
  Time frame: Throughout the study until week 48

Sponsor's own description

CYT006-AngQb is a vaccine that induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Angiotensin II. The vaccine is administered by subcutaneous injection.

The objectives of the study are:

* To evaluate safety and tolerability of 5 s.c. injections of 300µg CYT006-AngQb with Alhydrogel™ in patients with mild to moderate essential hypertension (hypertension Grade I and II).
* To assess pharmacodynamic effects, i.e. anti-Ang II immune response and renin- angiotensin system (RAS) biomarkers.
* To explore the effect on blood pressure using ABPM.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The renin-angiotensin system biomolecular cascade: a 2022 update of newer insights and concepts.
   Ferrario CM, Groban L, Wang H, Sun X, et al · · 2022 · cited 32× · PMID 35529089 · DOI 10.1016/j.kisu.2021.11.002
2. Senolytic Vaccines from the Central and Peripheral Tolerance Perspective.
   Vasilieva MI, Shatalova RO, Matveeva KS, Shindyapin VV, et al · · 2024 · cited 1× · PMID 39772050 · DOI 10.3390/vaccines12121389