Vaccine Response Impaired
Conditions
Brief summary
The purpose of this is that the researcher can use low power Near Infrared laser treatment non-painful and non-damaging dose to changes the skin properties.The researcher can prove that signaling and a significant increase in the number of skin cells in skin tissue exposed to the laser can improve the human skin immune system to help improve human body response to vaccines.
Detailed description
The researcher can use low power laser light one-minute exposures delivered to the skin at non-painful and non-damaging dose. The resulted in significant immunologic changes in the skin that included up-regulation of specific skin tissue and skin genes and the activation and mobilization of specific skin cells. In the first part of the study, the researcher will make a determination of the laser irradiance that will be tolerated. The highest irradiance the subject tolerates for 1 minute will be identified as that subject's maximum tolerable irradiance. After all subjects are tested, researcher will select the highest irradiance that was tolerated and use this in the second phase of the study. Approximately 24 hours after the first test exposures, each subject will receive a one minute laser treatment at the maximum tolerable irradiance. Four hours later, two skin biopsies will be collected from laser treated site a untreated. One tissue sample will be test at UC Irvine Dept. of Dermatopathology to evaluate microscopic skin changes, one skin sample will be delivered to Massachusetts General Hospital to evaluate RNA and protein expression.
Interventions
OTHERlow power laser
Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
Sponsors
Massachusetts General Hospital
Beckman Laser Institute University of California Irvine
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult men and women with skin type 1 and 2 * Not pregnant
Exclusion criteria
* Use of systemic steroids, topical steroids, tanning solutions and anticoagulant * History of HIV, mentally incompetent, prisoner, alcohol or drug impairment * Abnormal photosensitivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Tissue Response to a Vaccine | up to 12 months | Change in inflammatory cells with low level laser will be measured. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Power Laser Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
low power laser: Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Low Power Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 41 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in Skin Tissue Response to a Vaccine
Change in inflammatory cells with low level laser will be measured.
Time frame: up to 12 months
Population: We expect to demonstrate that the NIR laser dose elicits statistically significant dendritic cell trafficking to the human skin and induces cytokine/chemokine release and expression changes similar to that previously seen in mice.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low Power Laser | Change in Skin Tissue Response to a Vaccine | Epidermis CD1a+ Langerhans cells Normal Control | 39.0 Total number of CD1a+ cells (5hpf) | Standard Error 1.6 |
| Low Power Laser | Change in Skin Tissue Response to a Vaccine | Epidermis CD1a+ Langerhans cells Cases | 36.1 Total number of CD1a+ cells (5hpf) | Standard Error 1.6 |
| Low Power Laser | Change in Skin Tissue Response to a Vaccine | Dermis CD1a+ Langerhans cells Normal Control | 21.5 Total number of CD1a+ cells (5hpf) | Standard Error 2 |
| Low Power Laser | Change in Skin Tissue Response to a Vaccine | Dermis CD1a+ Langerhans cells Cases | 11.8 Total number of CD1a+ cells (5hpf) | Standard Error 1.6 |