Development of a Live Biotherapeutic Product as a Vaginally Disintegrating Tablet to Prevent HIV Infection

Women worldwide continue to be infected with HIV at an alarming rate. The majority of Human Immunodeficiency Virus (HIV) infections occur by the mucosal route during unprotected vaginal sexual intercourse. Several commensal Lactobacillus species generally dominate the vaginal microbiota of healthy women of childbearing age and are associated with vaginal health and a reduced risk of bacterial vaginosis (BV), human immunodeficiency virus (HIV), and other sexually transmitted infections (STIs), including herpes simplex virus-2 (HSV-2), and Neisseria gonorrhoeae (gonorrhea). These lactobacilli produce hydrogen peroxide and high levels of D-lactate/lactic acid, which contribute to the maintenance of a low vaginal pH (4.0-4.5) and inhibition of genital pathogens. Osel has bioengineered vaginal lactobacilli to secrete potent HIV inhibitors. These recombinant bacteria can persist on the mucosal surfaces where HIV is transmitted and represent an ideal platform for the development of novel woman-controlled and coital-independent biotherapeutics. In a recent proof of concept study our recombinant lactobacillus prevented simian (S)HIV infection in a macaque vaginal challenge model. The lactobacillus product (MucoCept) has been formulated as a tablet, which is stable for over a year at 4-25oC. MucoCept is being developed as an Investigational New Drug/Live Biotherapeutic Product (LBP) to prevent HIV infection in women. Role of Microbiota-gut-brain Axis in Mental Health with the Emphasize of Autoantibodies: Effect of Probiotics and Nutritional Interactions Afaf El-Ansary , and Laila Al-Ayadhi King Saud University, Saudi Arabia Abstract Microbial colonization of mammals is an evolution-driven process that modulates host physiology, many of which are associated with immunity and nutrient intake. The gut microbiota is increasingly recognized as a complex signaling network that impacts on many systems beyond the enteric system modulating, among others, cognitive functions including learning, memory and decision-making processes. This has led to the concept of a microbiota-driven gut–brain axis, reflecting a bidirectional interaction between the brain and the gut. Immune mechanisms that maintain intestinal homeostasis tend to minimize contact of intestinal bacteria with the gut epithelium. Gut microbiota can elicit signals via the vagal nerve to the brain and vice versa. Modulation of transmitters (e.g., serotonin, melatonin, gamma-aminobutyric acid, histamines, and acetylcholine) within the gut is yet another possible mechanism of action that could mediate the effects of the gut microbiota on mental health. Recently new data further validates a role for molecular mimicry and auto-antibodies in mediating the gut–brain axis and subsequently participating in the development of depression and neurodevelopmental disorders, such as autism and schizophrenia. The relationship between diet and the gut microbiota progresses and became more meaningful. Microbiota-dependent response of J of Food Chemistry & NanotechnologyMicrobial colonization of mammals is an evolution-driven process that modulates host physiology, many of which are associated with immunity and nutrient intake. The gut microbiota is increasingly recognized as a complex signaling network that impacts on many systems beyond the enteric system modulating, among others, cognitive functions including learning, memory and decision-making processes. This has led to the concept of a microbiota-driven gut–brain axis, reflecting a bidirectional interaction between the brain and the gut. Immune mechanisms that maintain intestinal homeostasis tend to minimize contact of intestinal bacteria with the gut epithelium. Gut microbiota can elicit signals via the vagal nerve to the brain and vice versa. Modulation of transmitters (e.g., serotonin, melatonin, gamma-aminobutyric acid, histamines, and acetylcholine) within the gut is yet another possible mechanism of action that could mediate the effects of the gut microbiota on mental health. Recently new data further validates a role for molecular mimicry and auto-antibodies in mediating the gut–brain axis and subsequently participating in the development of depression and neurodevelopmental disorders, such as autism and schizophrenia. The relationship between diet and the gut microbiota progresses and became more meaningful. Microbiota-dependent response of J of Food Chemistry & Nanotechnology