Clinical Trial Assessing the Safety and Immunologic Correlates of Heterologous Prime-Boost With pNGVL4a-Sig/E7(Detox)/HSP70 and TA-HPV in Healthy Donors Followed by Peripheral Blood Collection

Description

Scientists have found that a family of viruses called the Human Papillomavirus (HPV) can cause certain cancers, particularly in the head and neck and cervix. Most of these cancers are caused by a specific type of HPV called HPV16. This research is being done to see if giving an investigational vaccine against HPV causes the participant’s immune system to respond against proteins that are made by the vaccine and by the cancer in the participant’s relative. The investigators would like to see if cells of the immune system that have responded to the vaccine can be found in the participant’s blood. In a separate study the investigators will test if the blood and immune cells from the participant’s blood can be given safely to the participant’s relative and if the participant’s cells cause the cancer in the participant’s relative to shrink.

The first two shots the participant would be given are a vaccine called “pNGVL4a-Sig/E7 (detox)/HSP70”, and it contains DNA, the blueprint for making proteins. This vaccine is given as a shot into a muscle either in the shoulder or in the thigh. This will be followed by a third shot called “TA-HPV” which contains a vaccinia virus that helps the first shot to work by creating the T cells needed to fight cancer. After receiving the vaccines, the study team will collect the participant’s immune system cells to give to the participant’s relative with cancer. The collection will either be by bone marrow harvest or collection of the participant’s circulating blood, depending on the group to which the participant and the participant’s relative are randomized after enrolling in the trial.

The use of this heterogeneous vaccination strategy in this research study is investigational, which means that the vaccine regimen is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of the vaccine regimen in this study. Based on prior clinical studies, it is expected that this vaccine regimen and routes of administration will be well tolerated.

In this research the investigators will also be collecting blood samples that may also be used in the future by researchers.