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Improving Flu Vaccination

October 6, 2007

by Chaya Venkat

Jab & Dab:
At Last We Have Liftoff!

Related Articles:
Improving Immunization;
Topics Alert #160;
Topics Alert #226;
Sponsorship Philosophy.

balloon ascent

Readers of CLL Topics who have been with us for more than a year know we have been trying to get a clinical trial going, affectionately named “Jab & Dab”, in the hopes of improving the efficacy of flu vaccinations for CLL patients. I am delighted to report we have finally achieved liftoff: the clinical trial in the UK that we are sponsoring is finally ready to recruit patients and in time for the upcoming flu season. Looking at the early indications coming in from Australia (remember, the Aussies get the flu season ahead of us), it looks like it will be a nasty one this time.

Listing in NCT00596336.

Brief Overview of “Jab & Dab”

Links to our previous articles on this subject are given above, and I strongly urge you to read them to get all the details. But for your convenience, here is the cheat-sheet version:

  1. CLL patients are more at risk of catching the flu in the first place, and then having a harder time of dealing with it if they do catch the bug. Let’s face it, our guys are generally older, and our compromised immune system means our defenses are not exactly up to snuff. All too often, a garden variety flu infection can precipitate more dangerous lung complications. As I keep preaching, pulmonary infections are the single biggest cause of death in CLL.
  2. Unfortunately, CLL patients do not respond very well to vaccinations of any kind, and that is true for the annual flu shot as well. More at risk of catching the bug in the first place, and vaccinations are less protective: this is a dangerous double whammy for our guys.
  3. In the Spring of 2006 we developed an interesting concept that we hoped might improve flu vaccination efficacy for CLL patients. In a nut shell, there is an FDA approved drug called Aldara (scientific name “imiquimod”) used to treat actinic keratosis (incipient skin cancer) and human papillomavirus (HPV, a pathogen that causes warts, even cervical cancer). What makes imiquimod interesting is that it is thought to wake up the immune system, make it sit up and take notice of what is going on and thereby respond better to the target pathogens presented to it in the vaccination. So much so that imiquimod is in various clinical trials as an adjuvant in cancer vaccines to try and improve vaccination efficiency. (See abstracts on Cutting Edge: Priming CTLs and Imiquimod as Adjuvant to Weakly Immunogenic Vaccines.)
  4. We don’t have a vaccine for CLL, yet. But we do have an annual issue with influenza. Putting the two pieces together, we contacted a number of researchers to see whether they would be willing to conduct a clinical trial where CLL patients are given a flu shot, followed by topical application of imiquimod ointment at the site of the flu shot. Jab with the flu shot, followed by Dab of imiquimod ointment. Jab & Dab. You get it?
  5. We were fortunate that we were able to get Dr. Hamblin interested in this concept (you can read his thoughts on the subject in Imiquimod Trial, an entry on his blog). For a variety of reasons, including plain old getting all the paper work done in time, we were not able to launch the trial last year. To tell you the truth, I was deeply disappointed by the delay. This “baby” is close to my heart, and I really wanted to see it off to a good start ASAP.
  6. We are luckier this year. The Royal Bournemouth Hospital, Bournemouth, Dorset, UK is ready to start recruiting patients for this trial, under the guidance of our principal investigator, Dr. Helen McCarthy. Here are the links for the clinical trial protocol and the patient information sheet. Please be sure to read both of them carefully if you are interested in participating in this trial.
  7. In the next few days, letters will be going out to newly diagnosed and untreated CLL patients associated with the Royal Bournemouth Hospital, inviting them to participate in this clinical trial. Those in the area who are interested in participating can certainly contact the principal investigator, Dr. Helen McCarthy, and ask to be included.
  8. I regret this trial is being offered at only one site, the Royal Bournemouth Hospital. But I strongly emphasize, CLL does not respect geographic or political boundaries. Information we learn from this UK trial will be of immense value to all in the years to come. Once again, take a bow ladies and gentlemen. Your hard earned cash and generously offered donations are helping to pay for this trial. Our sister organization, the UK-based CLL Support Association is also participating in sponsoring and supporting this clinical trial.

The Importance of Your Participation in this Clinical Trial

If you are one of the lucky few that get a letter of invitation to participate in this trial, I hope you will sign up for it. I would, in a New York minute. Even a small improvement in the percentage of CLL patients who respond to flu shots will mean many lives saved and much suffering prevented. And the results could have much more significant value, in the sense that we are not the only immune compromised patient community. The same concept may be of value in other groups of people with less than pristine immune systems. Proving the concept in a well conducted clinical trial with unimpeachable expert supervision will be very valuable.

I am very pleased with the clinical trial protocol. It has a terrific design. The target is to recruit sufficient number of patients to yield statistically meaningful results. There are adequate and well matched control groups, both with and without CLL, who will get only the regular flu shot and not the imiquimod ointment. Using spouses of CLL patients as the control group is a stroke of genius! This way, our control group of non-CLL patients will be roughly the same age, exposed to roughly the same family and community and therefore share similar risk profiles. By using patients who have already been tested for the various prognostic indicators at the Bournemouth Hospital as the standard CLL patient workup, the trial will be saving a ton of money that would otherwise be needed for characterizing the participants. All in all, I think this is one heck of a good trial design. Kudos to the researchers!

Imiquimod (“Aldara”) has an enviable safety profile in human use. People at risk of skin cancer (“actinic keratosis”) or even full blown squamous cell carcinoma have been using this FDA approved drug for a while. In fact, recent guidance suggests that after basal cell cancers are removed by Moh’s surgery, it should be followed by Aldara use to prevent recurrence of skin cancer. Skin cancer patients use the imiquimod ointment on large areas of skin, for months at a time, with few adverse effects. As a participant in this trial you will be using it for just a few days, in a small patch right at the site of the flu shot. I cannot think of a lower risk profile than that.

Will you personally benefit from participating in this trial? There is no guarantee of that, there is no guarantee that this concept will even work, and that is the honest truth. That is precisely the reason for doing the trial in the first place, to find out if it works! Whether or not the trial is successful, the information we get from doing this trial will be invaluable. And generations of CLL patients coming after you will thank you for your participation in this trial.

How About the Rest of Us Chickens?

  1. As I said above, this year’s flu season is likely to be a bad one, and I am not talking about “bird flu”! Even though your chances of responding to the vaccination are not very good, you should nevertheless get the flu shot as soon as it becomes available in your community. Even a small percentage chance of a successful response to the vaccination is better than no chance.
  2. “Herd immunity” is particularly important for us. Even if we are personally not protected by the flu shot, if everyone around is protected, chances are better that we won’t catch the flu either. In other words, bug all your family members to make sure they get their flu shots. Their good health increases your own chances of avoiding the flu.
  3. Please take reasonable precautions, avoid crowds at the height of the flu season and wash your hands every chance you get! I make sure PC and I always carry a small bottle of alcohol gel in our pockets when we go out, and we use it frequently to sanitize our hands. Keeping your hands clean and practicing prudent “social distancing” from obviously sick folks goes a long way to protecting yourself.
  4. Grandkids can be adorable germ magnets. Use common sense in dealing with family members who have the sniffles.
  5. I am told Tamiflu is effective against garden variety flu as well. But please check this with your own doctor. In any case, Tamiflu is a prescription drug and your doctor will have to write a script for it.
  6. Here is a link to what the Center for Disease Control has to say by way of guidance: CDC Guidance.

“Jab & Dab” Outside the Clinical Trial?

Last but not least, what about patients who want to follow the Jab & Dab protocol outside of the official clinical trial?

Obviously, I cannot give you medical guidance and I am certainly not qualified to do so. I have no desire to practice medicine without a license, nor do I want to encourage you to be reckless. Just as obviously, I cannot stop you from doing anything you want to do. So, here is what I want to get across to you. Self-medication without appropriate guidance from your doctors is a foolish thing to do. I cannot say this in any stronger terms. Nobody, and I mean nobody, should be considering doing this protocol on their own, without getting advice, consent and supervision from their local healthcare providers. By all means, please print out the clinical trial protocol and the patient information sheet for your doctor to study carefully. Imiquimod is a prescription drug, and not cheap either. Be smart, be sure to get medical guidance and get your doctor’s approval before you indulge in “experimentation”. This is not a coy ‘CYA’ caveat on my part, I really mean it.

I also want to point out a simple fact of life. A boatload of anecdotal evidence based on individual patients and what they do with the permission of their doctors will carry no weight. We absolutely need the results of a well-documented, well-conducted and officially sanctioned clinical trial before anyone will take this concept seriously. So, all you guys who get to participate in this trial, thanks from the rest of us. We wish you luck, and to be honest we are just a tiny bit jealous of your good fortune in being able to participate in this trial. With luck, your efforts will make it possible in the future for many more of us to get our annual flu shots with an immune adjuvant such as imiquimod and thereby be better protected by the vaccination.




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Tulips: Bournemouth


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