Why are we doing this study?
The purpose of this study is whether your body produces the same concentration of antibodies (ie has the same immune reaction) to the influenza antigens in influenza vaccines if you give yourself a dose of Intanzaź - a new influenza vaccine given by injection into the skin - as if a nurse gives you a dose of the same vaccine.
We are carrying out this study to ask if adults who wish to receive influenza vaccine are able to give themselves this new vaccine without having a nurse present. If this is true, it would provide the opportunity to substantially simplify vaccination programs, and potentially to enable faster and more effective delivery of vaccine in outbreak and pandemic situations.
Who is being asked to participate?
This study will be carried out in Halifax and Toronto. It will include about 276 people, with about 139 being enrolled in Toronto.
We are asking for people who are:
- 18 to 59 years old & generally healthy
- Who have not received any vaccine within past month
- Have not received the 2010-11 influenza vaccine
- Have no previous severe reaction to the influenza vaccine, and
- Have no allergy to eggs or other influenza vaccine components
If I agree to participate, what will I need to do?
-
Agree to be randomized to receive either the regular 2010 seasonal influenza vaccine given as an intradermal injection by a nurse or to try giving yourself the same vaccine. The study nurse who gives you your vaccine will watch you to assess whether you have administered it successfully. Other study staff (those who review vaccine adverse events with you and test your blood for antibody) will not know whether you gave it to yourself, or had a nurse give it to you. At the end of the study, the nurse will let you know if there were any concerns about you administering your own vaccine. If there are, you will be offered regular influenza vaccine given by the nurse (your choice of intradermal or intramuscular vaccine);
- Fill out a short questionnaire about yourself, your health, your previous vaccination history and your experience (if any) with giving injections;
- Answer a few questions after vaccination about the vaccination and what vaccine you would prefer in future;
- Have 2 samples of blood drawn; the first just before you are vaccinated and the second, about 21 days after you are vaccinated. These blood samples will be used to test your immune systems level of activity against influenza;
- Keep a diary every day for 7 days after your vaccination. It will be to record whether or not you have any of a list of specific symptoms (e.g. headache, sore arm);
- Talk to the study office (by telephone or in person) on or about day 7 after vaccination to review your diary information; and
- Let the study know on day 21 (when you have your second sample of blood taken) whether or not you have had any illness since your vaccination.
How long will the study last?
This study will last 21-24 days, until you come in to have your blood drawn for the second time.
The first study visit, for enrolment and vaccination, will take 20-60 minutes, depending on how many questions you have before you decide about study participation and which group you are randomized to
The visit/telephone call at day 7 will require 5-10 minutes
The final study visit at day 18-23 will require 10-20 minutes
Are there any risks to participating in the study?
The vaccine being used in the study (Intanzaź) cannot cause influenza because it is made with a killed virus. It is not a live vaccine. It is licensed in Canada.
There is no reason to believe that there is a difference in adverse events with different types of influenza vaccine. Influenza vaccination may be associated with soreness or redness at the injection site. The intradermal injection may be more likely to cause a visible bump or some hardness in the skin for a day or two. These reactions are usually mild.
Allergic reactions to vaccines, including urticaria (hives) and anaphylaxis (severe allergic reaction) are rare, but can occur. Two other very rare adverse events of influenza vaccination have been described. Oculo-respiratory syndrome is redness and irritation of the eyes, and swelling of the face that starts within a few hours of vaccination, and lasts a few hours. It occurs in about 1 in 10,000 vaccinations, and is not dangerous, but may be frightening. Guillan Barre syndrome is a neurologic disease which causes temporary paralysis that appears to occur at a rate of about 1 per million vaccinations; it can also complicate influenza.
If, when you administer the vaccine yourself, the nurse judges that you may have not successfully use it, you may wish to receive the regular influenza vaccine. This means another injection, which may be associated with arm soreness and redness.
The study vaccine may contain small amounts of egg proteins and neomycin left over from the manufacturing process. These components are not unusual and are found in other vaccines, but you should tell the study staff if you believe you are allergic to either of these, have any serious allergies, or have had an allergic reaction to a vaccine in the past, as you may not be able to take part in this study in this case.
As with any vaccine or drug, unexpected serious reactions, including severe allergic reactions may occur. All the medical equipment to treat any serious reactions to the vaccine will be available at the time of your vaccination. If this should happen, Dr. McGeer or another doctor will see you and give advice about any necessary treatment.
Dr. McGeer and the study staff will notify you if there is any new information about this study you should know about while taking part in the study.
The blood tests that will be done can cause momentary pain and sometimes a small bruise.
Who can I contact if I am interested in the study?
You can call the Toronto study office at 416-586-4800 ext.2767 or email us at IDresearch@mtsinai.on.ca. A member of the study staff will then arrange to talk to you in detail about the study so you can decide whether or not you wish to participate.
Investigators
- Dr. Shelly McNeil
- Dr. Allison McGeer
- Dr. Scott Halperin
- Dr. Joanne Langley
- Dr. Brenda Coleman
Please note that you will be not have to pay for any of the procedures involved with this study. You will be provided with $25 per study visit to cover the costs of travel and parking, and compensate you partially for your time.
