After months and months and months of waiting, we finally had our first day of vaccination!! It went as I expected it: a little disorganized, getting things done last minute, and anti-climactic. I had been waiting for this day for so long that when it actually came and was over, it seemed like nothing at all. But it was still incredible!!!
We invited 21 of our screened patients who satisfied all of our requirements for inclusion and exclusion into our trial, of whom 18 would actually get vaccinated. My role that day was one part clinician (assisting the Malian doctors with the clinical assessment) and 5 parts logistics man, mainly the cameraman. Part of the confusion that resulted the day before dealt with the camera. The study site camera stopped working, so I volunteered the use of my digital camera to take the participant’s photos. The plan was to hand off the camera to the researchers in charge of clarifying identification, but for some reason it would not work for them. So, I was given the task of photographer for the day. It was fun taking pictures of the kids we would vaccinate. The hardest part there was trying to get them to smile. There is not the same photo-crazed climate as in the
We were able to vaccinate our desired number of participants, some of which would receive the malaria vaccine, and others of which would receive the active control vaccine, Hiberix (which protects against a bacteria called Haemophilus influenza, one of the leading causes of strep throat, ear infections, and more seriously, pheumonia and meningitis, in children). True to most drug/vaccine clinical trial, none of us knew who received what. This allows us to evaluate everyone without prejudice to what they received.
From here on out, the work is mostly follow-up. Each participant must return to the clinic on a set schedule for a clinical evaluation and occassionally lab work to make sure the vaccine has not affected their health in ways that cannot be measured by signs and symptoms alone. About a month after their first vaccination, they will receive a second vaccination. The purpose of this 2nd vaccination is to boost their immune system response to the particular protein on the malaria parasite that our vaccine is targeting. After that 2nd vaccination, they will continue to return to the clinic periodically for clinical evaluation and lab work for the following year.
Perhaps the most important part of the follow-up will happen when my fellowship period is over. In addition to their regular clinic days, we will be also be periodically evaluating their malaria status during the intense transmission season here (mainly August - November) to determine if they are adequatelyprotected or not. Sometimes, people can be infected with malaria, but not show symptoms of disease. We hope to see if this is this occurring in these patients. We also expect the participants to come to the clinic at any time for any complaints or illnesses that come up, as part of their compensation is complimentary medical care during the course of the study.
Lastly, I feel it is important to clear up one imporant point. I think people need to realize that we are just getting started with our understanding of the immunology of malaria and in the vaccine development process, and we have a long way to go before we have a marketable malaria vaccine. There are many, many issues that need to be addressed (i.e. type of vaccine target, falciparum vaccine only vs. vaccine for other types of malaria, genetic diversity of malaria, target population (kids vs. travelers), etc.) before we can say we have an adequate vaccine.