Full Q&A Transcript: The Seattle Clinical Malaria Trials Center

6. What stage of vaccine development and testing is the MCTC currently at? Is there a current project that is most promising?

Answer: Our center conducts phase 1 and phase 2 studies of vaccines and drugs. We are currently testing a vaccine manufactured by Sanaria, which is based on an attenuated whole organism vaccine that is given by direct venous injection. At the moment, this vaccine has the most clinical data of any product that we have worked with and represents a promising first-generation malaria vaccine.

7. If someone was considering becoming part of the MCTC is there anything you would want to say to them to encourage their participation?

Answer: We have more than 10 years of experience here in Seattle running human challenge studies. Challenge studies are safe, and the experience has been very meaningful to participants. There are always unknown risks about participating in clinical trials, but we provide the best and most complete information that we can to our participants and are not satisfied until their questions are answered. We have a tremendous and engaging team who would be happy to answer questions of prospective participants. Participants can find out information by going to our Seattle MCTC website, www.seattlemalaria.org, and click “Sign Up.”

8. Can you tell us what the general timeline / tasks of a study participant looks like?

Answer: When someone expresses interest in a clinical trial, usually they do so through an email or web form. The trial coordinator does a phone pre-screen to see if they might be eligible for a given trial. If they are a good candidate then we schedule an in-person screening visit to obtain informed consent, ask more questions, do a physical exam, and obtain blood to get some baseline labs. If all  that information looks like the participant is eligible and the participant  can commit to the clinical trial schedule, then they might be enrolled in the study.

When the study starts, the participants come in on each scheduled day. For a drug study for example we might give the drug, and then closely observe the participant over the next hours and days including sometimes having the participants stay in a hotel overnight where staff and other participants stay as well. This allows us to check in on participants on a frequent basis and often to collect repeated blood samples to be able to monitor the levels of the drug in the hours and days that follow administration.

Vaccine studies usually take place over a longer period because there are usually weeks to months between the doses given for vaccines. So, for example a participant might come in to receive the first dose, and then come back in the days that follow to give blood samples to monitor the right response of the immune system to the first dose, and then get another dose a few weeks or a month later, this might be repeated two or three times depending on the vaccine.

When we do malaria challenge, the participants come in perhaps a month after their last dose of vaccine or a few days before or after receiving a drug and they receive either mosquito bites or a small injection of preserved parasites that can cause an actual infection. In the days that follow we closely monitor the participants for signs of the infection in their blood using a sensitive PCR test and for symptoms that might indicate that they are developing a malaria blood stage infection.. Of course, if the vaccine or drug does its job then the participant does not have any sign of infection and the drug or vaccine dose is deemed to be a success. When someone does develop a blood stage infection then we inform them and treat them with FDA approved drugs that rapidly clear the parasites from their system. We follow up with the patients at additional visits to make sure that they continue to feel well and eventually we have a closeout visit that designates the end of the trial.

There can be relatively few visits let’s say five or six or there can be very intensive visits schedules with more than 30 or 40 visits during a clinical trial. For this reason, our participants must be very committed to the study and we have been very successful in recruiting such generous volunteers. Participants are also paid for their time as they progress through the trial. Except for a few days where the sampling is very intensive or in cases where people spend a few days in the hotel with the team, most participants are able to go about their daily business, go to work etc.

9. Are there ways to get involved or contribute to your work if you are not eligible or prefer not to be a study participant?

Answer: Social media is an excellent tool for recruiting participants and we would ask people who are interested in our work but cannot participate to perhaps follow us and spread the news about our recruiting efforts when we have active trials. It is also valuable for the public to be aware of the public health importance of malaria and other diseases like this and to advocate for support of these programs at the local, state, and federal levels (Click Sign Up at www.seattlemalaria.org).

10. What are the exciting next steps in research you plan to be taking?

Answer: The institutions in Seattle contributing to the generation of immunology results and world-class, and the analysis of this data is a high-dimensional computational challenge. That said, we have the expertise to interrogate these immune responses to find what may be most meaningful for future vaccine development. Dr. Kublin is exploring the T-cell receptors associated with protection, and Dr. Murphy would like to move forward with prime and trap Vaccines as noted above. Most exciting is seeing the enthusiasm of volunteer to either participate in our clinical trials or assist us in any other ways. It is a citizen driven scientific endeavor, and we are fortunate to be involved.