Subjects with type 1 diabetes depend on insulin injections or infusions to regulate their blood glucose levels. Recently, researchers described the first-ever human phase I clinical trial of a "inverse vaccine" to treat type 1 diabetes patients.
An "inverse vaccine" is designed to stop a specific immune response such as the unwanted autoimmune response that destroys beta cells in patients with type 1 diabetes. This treatment aims to retrain the patient's immune system to self-tolerate the insulin-producing beta cells in the pancreas. The methodology is that specific immune cells called dendritic cells are collected from the patient's blood and are specifically treated particularly with pro-insulin peptide and vitamin D. When the stimulated cells are injected back into the patients, in a series of vaccinations, they can elicit a specific subset of the patient's T cells (regulatory T cells, or Tregs), which in turn, act to regulate the unwanted autoimmune response seen in type 1 diabetes. The novel vaccine was recently tested to assess safety and tolerability in nine patients with type 1 diabetes of long duration (at baseline, only three patients had detectable C-peptide levels, indicating some degree of insulin production. Clinicians monitored various health parameters throughout the trial, including glycemic management, which remained stable for all participants. The treatment passed the phase 1 clinical trial with respect to serious adverse events.
The researchers explained that such a tailored approach constitutes a previously unexplored form of treatment for patients with type 1 diabetes which could lead to effective therapies, and perhaps even a cure.