NCT00500786

Safety, Tolerability, Pharmacodynamic Effects and Preliminary Evidence for Efficacy of the Anti-Hypertension Vaccine CYT006-AngQb

Completed Phase 1/Phase 2 Last updated 20 August 2012

What this trial tests

Phase 1/Phase 2 trial testing CYT006-AngQb in Essential Hypertension in 88 participants. Completed in 1 April 2007.

Timeline

1 November 2004

Primary endpoint
1 September 2006

1 April 2007

Quick facts

Lead sponsor	Cytos Biotechnology AG
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	88
Start date	1 November 2004
Primary completion	1 September 2006
Estimated completion	1 April 2007

Drugs / interventions tested

• CYT006-AngQb — full drug profile →

Conditions studied

• Essential Hypertension — all drugs for Essential Hypertension →

Sponsor

Cytos Biotechnology AG — full company profile →

Who can join

Adults 18 to 65, any sex, with Essential Hypertension. Healthy volunteers can join.

Sponsor's own description

This is a multi-center, randomized, placebo-controlled, time-lagged, parallel-group study in healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine CYT006-AngQb. The trial is double-blind for active vs. placebo within each treatment arm, but open with respect to AngQb dose escalation.

In the first arm, 16 healthy normotensive volunteers are treated with a one dose regimen consisting of a single s.c. injection of 100µg of AngQb or placebo. Upon satisfying safety and tolerability profile, as judged by the independent safety monitoring board, arm two is enrolled.

In arm two 36 patients with mild to moderate hypertension receive three s.c. injections of 100µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections are given 4 and 12 weeks after the first injection, respectively. Upon satisfying safety and tolerability profile, as judged by the independent safety monitoring board, arm three is enrolled.

In arm three 36 patients with mild to moderate hypertension receive three s.c. injections of 300µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections are given 4 and 12 weeks after the first injection, respectively.

The primary objective of the trial is to evaluate safety / tolerability of 3 dose regimens of CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension. Secondary objectives include the assessment of pharmacodynamic effects and their dose-response (immunogenicity and biomarkers of the renin-angiotensin system), and the exploration of clinical efficacy (effects on systolic and diastolic blood pressure)

Publications & conference data

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

1. Effect of immunisation against angiotensin II with CYT006-AngQb on ambulatory blood pressure: a double-blind, randomised, placebo-controlled phase IIa study.
   Tissot AC, Maurer P, Nussberger J, Sabat R, et al · · 2008 · cited 187× · PMID 18328929 · DOI 10.1016/s0140-6736(08)60381-5
2. <i>Escherichia coli-</i>derived virus-like particles in vaccine development.
   Huang X, Wang X, Zhang J, Xia N, et al · · 2017 · cited 93× · PMID 29263864 · DOI 10.1038/s41541-017-0006-8
3. Current progress in the development of prophylactic and therapeutic vaccines.
   Li T, Qian C, Gu Y, Zhang J, et al · · 2023 · cited 39× · PMID 36469218 · DOI 10.1007/s11427-022-2230-4
4. 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
5. Development of therapeutic vaccines for the treatment of diseases.
   Tian Y, Hu D, Li Y, Yang L. · · 2022 · cited 30× · PMID 36477638 · DOI 10.1186/s43556-022-00098-9
6. 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
7. Immunotherapies for Aging and Age-Related Diseases: Advances, Pitfalls, and Prospects.
   Yang M, Wu S, Zhang J, Lu L, et al · · 2025 · PMID 40927754 · DOI 10.34133/research.0866