Animal Studies Indicate Vacc-C5 Generates Immune Responses to HIV, Similar to Those in HIV Patients who Naturally Suppress the Virus.
Bionor Pharma ASA announced today that the first study of Bionor Pharma's Vacc-C5 is now approved to begin at Oslo University Hospital. Vacc-C5 is a therapeutic HIV vaccine developed to slow down or stop induction of immune hyperactivation, a feature that drives the production of HIV and is damaging the immune system, leading to AIDS. Vacc-C5 also may have the potential to be a preventive vaccine, alone or in combination with Vacc-4x.
The phase I/II study will use Vacc-C5 at three different dose levels, in order to evaluate safety and provide a determination for the optimal dose of the vaccine, when given intradermally (in the skin) or intramuscularly.
"The pre-clinical studies of Vacc-C5 in rabbits, and sheep, as well as data confirming an association between high antibody levels and slow progression of HIV in humans have generated considerable interest," said Dag Kvale, MD, PhD, Principal Investigator at Oslo University Hospital. "We look forward to see how people living with HIV respond when on Vacc-C5."
The study seeks to recruit 36 patients who have been infected with HIV for at least one year. Study participants must have been stable on antiretroviral therapy (ART, traditional HIV medicine) for at least six months with a viral load of less than 50 copies per milliliter. The primary endpoint of the trial is to evaluate safety of the vaccine at three different dose levels. Secondary endpoints include measuring specific antibody and T-cell responses to Vacc-C5 and to evaluate T-cell activation markers. Vacc-C5 will be given in combination with two different adjuvants, (that enhance the immune response), either GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) or Alhydrogel (an aluminum-based treatment).
How Vacc-C5 is considered to Work, in Comparison to Vacc-4x Vacc-C5 generates antibodies based on modified, manufactured (synthetic) peptides from the C5 region (of gp 120) at the HIV-virus surface. Data suggest that anti-C5 antibodies may play a crucial role for Natural Viral Suppressors, a group of people who are able to control the HIV infection without the need of HIV medication.
Bionor Pharma has filed a patent application covering Vacc-C5.
The further strategy is to use Vacc-C5 in combination with Vacc-4x since Vacc-4x already has via T-cell (killer cell) responses shown to lower the viral load set point (stabilized virus level) by statistically significant levels compared to placebo.
"Where Vacc-4x appears to kill virus-producing cells, Vacc-C5 has the potential to reduce the damaging immune activation," said Birger Sorensen, EVP Head of Vaccines. "Looking ahead, we're very excited to study the two vaccines in combination, pending that safety and dosing are confirmed in this trial."
Bionor plans on studying the two treatments Vacc-4x and Vacc-C5 in combination.
Objectives and indications Vacc-C5 has potential both as part of a preventive vaccine, and as a therapy, by preventing or reversing immune collapse in chronically infected patients.
Researchers believe the antibodies induced by Vacc-C5 can be beneficial at all stages of HIV infection by slowing down or halting the disease progression, and by significantly reducing the production of virus.
Theoretically, Vacc-C5 could be used at any point in patient treatment, forming a part (together with Vacc-4x) of both therapeutic and preventive therapy.