Summary:
The purpose of this research study is to test an experimental hantavirus vaccine at different doses and with different injection devices to see which group has the most volunteers that make antibodies (used by the body’s immune system to identify and fight bacteria and viruses). We will also see how long antibodies last and get more information about the safety of the vaccine. The information may help us to make a hantavirus vaccine that protects people from HTNV and PUUV. After each vaccination, we will look at how the immune system responds.
You are being asked to participate in this study because you are a healthy adult (18-49 years old) who has not had hantavirus in the past or participated in a different hantavirus-related clinical trial, although we will confirm this using laboratory tests for hantavirus antibodies in your blood. This experimental vaccine has not been approved for sale by the US Food and Drug Administration (FDA). However the FDA is permitting its use for human research. The research study is approved by independent institutional review boards (IRBs) (special committees to protect the rights of people who are in research studies). This vaccine has been given to US citizens before at different doses.
This study will take place at the University of Maryland, Baltimore. A total of approximately 216 volunteers will be enrolled in this study. Of those 216 volunteers, approximately 72 volunteers will be eligible for vaccination and continued participation in this research study. You will be randomly assigned (like flipping a coin) to one of six groups depending on the time you are qualified for enrollment. You will be randomly assigned to the early pilot groups (2 and 4), the second pilot groups (5 and 6), or the remaining enrollment groups (1-6). Each group will have a vaccine to HTNV or PUUV or both and at different doses. We are also interested in whether it is better to inject the experimental vaccine in the muscle (like a typical vaccine) or in the skin (like a tuberculosis test). The study will be about 8-11 months long. The experimental vaccine will be injected in your arm 3 times over a two (2) month period, and alternating arms will be used each time you visit. During your study participation, we will perform various follow-up visits, tests, and sample collection. Some of these samples will be used for studying immunity to hantaviruses and some will be stored for future research.
Investigators plan to include 72 healthy men and women in the study. If you would like to be in this study, we will examine the results of your blood sample tests, a physical exam, and answers to questions at the screening visit to determine if you qualify to participate. To be in the study you must give your written informed consent (permission) before any exam or study procedure can be performed.
You must be:
- Willing and able to complete the requirements of the protocol, such as filling out the memory aids and returning for follow-up visits
- Willing to sign the informed consent before screening
- Able to score at least 80% correct on a short multiple-choice quiz to show that you understand the study.
- Between 18 and 49 years of age (you have had your 18th birthday and have not had your 50th birthday) at the time of consent
- Healthy when you start the study
- Sexually active men* and women** of childbearing potential* must be using an effective method of contraception from 30 days before the first study vaccination until 6 months after the last study vaccination. * A sexually active man is defined as one whose partner is a woman of childbearing potential (see definition below) and has not had a vasectomy performed > 1 year prior to screening. You must agree not to father a child until 6 months after the last vaccination. You must agree to use a barrier method of birth control (e.g., either condom with spermicidal foam/gel/film/cream or partner usage of occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository). **Women of childbearing potential are defined as those who have not been sterilized (e.g., tubal ligation, bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or successful Essure® placement [permanent, non-surgical, non-hormonal sterilization]) with history of documented radiological confirmation test at least 90 days after the procedure and are still menstruating or less than 1 year of the last menses if perimenopausal. For this study, an effective contraceptive method is defined as one that results in a failure rate of less than 1% per year when it is used consistently and correctly.
- Women must be willing to agree not to donate eggs and men must agree to not donate sperm from the date of screening until at least 6 months after the last vaccination
- Negative hantavirus PsVNA test result at screening
Qualified Participants May Receive:
If every visit is completed, then the compensation for the different schedules is $1260. In addition, if you fulfill all study duties, you will receive a $200 bonus for a total compensation of $1460.