Home
First in Man: First report of a pilot clinical trial, testing the safety and tolerability of a novel laser adjuvant in humans.

First in Man: First report of a pilot clinical trial, testing the safety and tolerability of a novel laser adjuvant in humans.

Recently at the Vaccine and Immunotherapy Center, Dr. Jeff Gelfand was published as the first author in the FASEB Journal, for his study titled “A pilot clinical trial of a near-infrared laser vaccine adjuvant: safety, tolerability, and cutaneous immune cell trafficking”.

 

This is the first report of a pilot clinical trial, testing the safety and tolerability of a novel laser adjuvant in humans.

 

Vaccination remains the single most important and cost-effective medical technology yet developed. Vaccines often require adjuvants to be effective. Furthermore, intradermal (ID) vaccination has significant advantages over the intramuscular (IM) route of administration, including reduced pain and a more direct route to the immune system through cutaneous dendritic cells (DC’s) and draining cutaneous lymphatics.

This study reports the development of a novel adjuvant to be paired with intradermal vaccination, namely nondestructive laser-light stimulation of the skin. In this study, we used a 1064 nm CW NIR laser. Near-infrared wavelength was chosen because the light of this wavelength is minimally absorbed by hemoglobin and melanin, thus enabling it to be used in individuals of all skin colors.

Using a blinded observer for dermatopathology evaluation, Gelfand and colleagues have demonstrated statistically significant increases in antigen presenting cells (APC’s) and cutaneous DC migration produced by nonpainful, nondestructive laser illumination. These changes have included highly significant decreases in both dermal Langerhans cells and dermal dendritic cells in the targeted skin 4 hours following laser illumination, corresponding to the increased migration of dermal dendritic cells to draining lymph nodes with the upregulation of a selective set of immune- potentiating cytokines, as repeatedly demonstrated in murine studies.

In the future the combination of this laser adjuvant with intradermal vaccination may help boost the efficacy of vaccines, amplifying the APC response and strengthening vaccination attempts.