GVAX Cycle 3

Up early – easy drive, no traffic. Everything went as expected. Three down, one to go!

Robert’s appointment at Johns Hopkins for the third set of injections of the melanoma GVAX vaccine was scheduled at 8:30, so we were up and out by 7 a.m. – way too early for a retired person like me. But perhaps that’s why the traffic was so light and we ought to ask for early appointments from now on!

The rest of the visit was a breeze, too. Weight stable, temp on the low side, blood pressure 120/89 – only slightly elevated from Robert’s norm. There were no problems with the blood draw (if you want a refresher on the potential, click here), and soon we were in the exam room answering questions from Dr. Lipson. Routine questions, same old answers – the same medications, no physical complaints, no systemic reaction to the last cycle of vaccine. Robert reported that the itching at the vaccine sites came on much more quickly after the December injections than in November, when the hard and red patches at the vaccine sites developed over a few days and stuck around for a few weeks. Last month the itching was furious by the time we returned home from Hopkins.

 Apparently this reaction is normal. Dr. Lipson said, “We see changes in both the severity and  rapidity of the symptoms over time, so cycle one is just minor, cycle two is more vigorous, and cycles three and four are more variable.” Robert noted also that although the reaction at the vaccine sites was slower in the first cycle, those sites were still detectable when he had the second set of injections. The sites from the second cycle have disappeared already – only the biopsy site is still evident, and he accepts that as a “scar for life.”

To which I say: “Maybe. Maybe not.” The vaccines are part of our effort to see to it that he lives long enough for us to find out!

While the study nurse, Susan Sartorius-Mergenthaler, was injecting the vaccines, Robert had a chance to ask her some crystal-ball questions about the vaccine. He wondered what researchers thought would be the future course of therapy, assuming the vaccine receives FDA approval. One possibility, Susan said, is that patients would get an annual “booster” injection – or at some other interval.

Robert also was curious whether researchers foresee giving the initial vaccination in a single set of injections rather than over four months. Susan said she thought the therapy required too much vaccine to be administered in one session. But who knows what mechanism they might eventually devise? I’m sure they would have started out with oral polio vaccine rather than shots, if only they knew how in the beginning ...

Susan also told us a little more about the study procedure – particularly the huge vials of blood they take from participants before each set of injections. She said the lab researchers save the samples and perform tests in batches rather than running all the tests on a single participant’s blood at the same time. They are collecting data over time and hope eventually to see patterns that help them understand how the body reacts to the vaccine. Also, she said, eventually Dr. Lipson will be able to share Robert’s data with us – to say whether they saw the particular immune reaction they are trying to induce.

We don’t know now whether the vaccine will be enough to prevent a recurrence of melanoma, and if Robert never has a recurrence, we won’t know for sure whether the vaccine prevented one that would have happened. All we know is that this is all we can do.

When we know more, we’ll let you know. Meanwhile, call or write if you have questions.