Hi all --

I had said we would post ongoing updates from the HPV-16 vaccine trial that Barry is officially entering this month. This is a DNA vaccine developed at Hopkins for possible therapeutic use in patients with HPV-16+ cervical or head/neck cancers. It is only in Phase 1 trial, thus a long way to go for clinical application even if found effective. Right now it is only given to patients who are considered (at time of trial) to be cancer-free post-treatment.

In brief, the hypothesis behind the vaccine is that the immune system of individuals with an HPV-cancer did not recognize (or effectively clear) the virus -- whereas although 80% of us are infected at some time with HPV-16, most of us "clear" the virus and it does not persist in our bodies. The vaccine will, it is thought, challenge the cancer patient's immune system to recognize and attack the virus and tumor cells containing the viral genomic material. It did work that way in the initial animal trials...(though as often said here, we are not mice...)

The protocol is that white blood cells are taken from the participant and tested for response to HPV, both before and after a series of 4 vaccine inoculations. There are 4 dosage levels of the vaccine, no placebo arm. Barry will get either dosage level 2 or 3.

There has been a on-going trial with this vaccine for cervical cancer patients, the final results (that is, did it stimulate the immune systems?) is not known yet as that trial is not finished. However what is known is that, with a larger number of participants, there have been no adverse side effects of the vaccine at any dose level (reassuring!)

Yesterday was only the first step -- Barry discussed the trial again with the study nurse and worked out a schedule, which is complicated by our upcoming trip to Australia in late July-August. It appears that (for this reason) he will not actually get his vaccinations until after we get back. They also took blood for a number of tests and made sure he was up to date on influenza & tetanus shots. And, most importantly, he signed the consent form.

The next step will be a series of skin tests to see if he might react to the (non-HPV) vaccine components,and also a skin test for TB and candida (yeast) -- the nurse said that since almost everyone with HNC had had thrush they all seemed to react to the candida test, no surprise there! A date will be set up for the phoresis (removal of white blood cells, similar process to platelet collection). He will then be good to go for the vaccine inoculations, which will start in September.

Anyway, this is Post #1 -- since not much will happen now until we get back in mid-August -- don't hold your breaths for Post #2!

Cheers,
Gail and Barry