Possible known and unknown side effects
WHAT ARE THE RISKS OF THE STUDY?
This is the first time a DNA plasmid vaccine has been given to humans. While on this study, you are at risk for side effects below and possibly others. There may be other side effects not listed that the researchers cannot predict. You should discuss these with your doctor.
The HER2 Plasmid Vaccine consists of a DNA plasmid vaccine given intradermally using a Pharmajet Tropis Needless injector. The possible side effects for each are described.
Possible side effects from immunization may include local effects (pain, tenderness, redness or swelling), systemic effects (malaise, fatigue, myalgia, arthralgia, headache, nausea, vomiting, chills or fever), and allergic reactions such as hives, rash or anaphylactic reactions. Induction of auto-immunity, manifesting as arthritis, serositis, nephritis, thyroiditis, colitis, neutropenia, etc., is theoretically possible, but has not been observed in prior plasmid vaccine studies. Also, liver function test abnormalities and liver failure are theoretically possible.
For treatment of hypersensitivity or anaphylactic reaction toxicities including but not limited to:
bronchospasm, stridor, wheezing, respiratory depression (RR < 8), cardiac arrhythmia, generalized urticaria, systolic BP ≤ 80mm Hg, angioedema, shock, or loss of consciousness, manage per institutional standards. Below are recommended guidelines for the management of hypersensitivity/anaphylactic reaction:
Remain at patient bedside
Have another nurse notify MD
NS at KVO, if hypotensive then give NS 500ml bolus
Start oxygen for dyspnea, stridor, wheezing or respiratory depression at 2 liters/nasal cannula, initiate continuous pulse oximetry and call RT
Diphenhydramine 50 mg IVP** x 1
Give methylprednisolone 125mg IV** x 1
Give epinephrine 0.3mg (auto-injector) x 1 IM x OR epinephrine 0.3mg (1:1000) SQ x 1 (may repeat x 1 in 5 minutes)
If no response to above interventions within 5 minutes or patient condition worsens, call a code (911 or institutional specified number).
Vital signs with pulse oximetry Q2 minutes until patient is stable, then Q5 minutes x 30 minutes and Q15 minutes for 1 hr or as the patient’s condition requires
**If no IV access or IV access lost, may give these agents IM as appropriate