To translate the potential advantages of recombinant adeno-associated virus type 1 (rAAV1) vectors into a clinical application for muscle-directed gene therapy for alpha1 -antitrypsin (AAT) deficiency, we performed safety studies in 170 C57BL/6 mice and 26 New Zealand White rabbits. A mouse toxicology study included 8 cohorts of 10 mice each (5 per sex). Mice were killed either 21 or 90 days after intramuscular injection of doses ranging up to 1x10(13)vector genomes (VG), equivalent to 4 x 10(14)VG/kg. A mouse biodistribution study was performed in 5 cohorts of 10 mice, receiving intramuscular injections at the same doses; as well as in a lower dose cohort (3 x 10(8) VG; equivalent to x 10(10)VG/kg); and in 4 other cohorts (excluding the vehicle control) injected with identical doses intravenously. Finally, biodistribution was examined in rabbits, with serial collection of blood and semen, as well as terminal tissue collection. Two significant findings were present, both of which were dose dependent. First, inflammatory cell infiltrates were detected at the site of injection 21, 60, or 90 days after intramuscular injection of 1 x 10(13)VG. This was not associated with loss of transgene expression. Second, vector DNA sequences were detected in most animals, levels being highest with the highest doses and earliest time points. Vector DNA was also present in liver, spleen, kidneys, and a number of other organs, including the gonads of animals receiving the highest dose. Likewise, vector DNA was present in the semen of male rabbits at higher doses. The copy number of vector DNA in the blood and semen declined over time throughout the study. These two dose-dependent findings have served to guide to the design of a phase 1 human trial of rAAV1-AAT.
It is possible to safely and accurately administer your injectable medications in the privacy of your home. Safe injection practices protect the patient, the person giving the injection, as well as the environment. The two common types of injections administered at home are subcutaneous, which includes the administration of insulin, and intramuscular injections. If you must give yourself injections or give injections to a close friend or family member, you must first learn how to do so from the healthcare provider who is prescribing the medication to be injected.
Q. My arm became limp after flu shot & have had pain in arm. Vaccine itself or improper injection? Any advice? I could not move my arm about 3 hours after the injection. It took about 3 days before I could raise my arm at all. It became painful to use and has bothered me for a couple of months. The doctor gave me a cortisone shot which helped some but not completely. He had never seen this reaction before. Is it a reaction to the vaccine or could it be the way it was injected? Is their anyone who has had or knows of a similar case? A. I had a flu shot last October, and it was given to me directly on the backside (and up high) of my shoulder. I went to the gym after I received the shot, and now have two tears in my (torn) rotator cuff, with a perforation in my rotator cuff tendon. I think it may have been improperly given. Now I need to have surgery to repair it. Look up your symptoms on webmd, and surf the net. Talk to your doctor too. The only way to find out what is really going on with it is to have an MRI. A simple xray will not reveal a tear in the muscle or tendon in the rotator cuff. If you can't lift your arm, and have trouble sleeping at night, and pain on your deltoid and bicep (rotator cuff injury pain radiates to these areas) because of the pain, then chances are you have an injured rotator cuff. These people giving these immunizations need more training. They are causing serious injury to people that go in to get a shot to stay healthy, and then end up with a serious injury, and possible surgery !!! Goo