This is a phase 2 study that is intended to assess two experimental vaccines at low and high doses; the Hantaan Virus DNA Vaccine and Puumala Virus DNA Vaccine. Phase 2a means that these vaccines have been tested in humans previously, and the results showed that they were safe and well tolerated. We repeat the study with more people and different doses, to verify the safety and get more data on the best dose for protection.
The main purpose of this study is to confirm that these vaccines are safe and tolerable. Another purpose of this study is to see if this experimental vaccine helps your body to make the antibodies that protect against hantaviruses.
To learn more about the Phase 2 vaccine trial or to enroll, contact the WRAIR Clinical Trials Center at 866-428-2788 or through email.
- ✔ MUSTBe between the ages of 18 and 49 years old.
- ✔ MUSTBe willing and able to participate in all planned study visits for the duration of the study.
- ✔ MUSTBe in good health.
- ✔ MUSTBe a adult male or non-pregnant, non-lactating female.
- NOTE:• If you are a female, you must agree to consistently use effective birth control at least 30 days before the first vaccination and through 3 months after the last vaccination. You must also agree not to donate eggs from screening until 90 days after the
- NOTE:• If you are male, you must agree not to father a child or donate sperm from screening until. 90 days after the last vaccination.
- ✔ MUSTagree not to participate in another clinical trial during the study.
- ✔ MUSTagree not to donate blood to a blood bank for 3 months after receiving the last study vaccine.
- ✘ CANNOThave any history of having been given a hantavirus vaccine.
- ✘ CANNOThave any serious medical illness or condition involving the heart, liver, lungs, or kidneys.
- ✘ CANNOThave a history of severe allergic reactions.
- ✘ CANNOThave received licensed vaccines within 7 days before or after immunization (30 days for live vaccines)
- ✘ CANNOThave a history of neurologic disease (including migraines or seizures).
- ✘ CANNOTlack the ability to observe possible local reactions at the injection sites (upper arm region) or if the injection areas are obscured due to a physical condition or permanent body art (tattoo).
- ✘ CANNOThave donated blood for human use (e.g., American Red Cross or other similar blood drives) within 2 months prior to study entry or if you plan to during the study period.
- ✘ CANNOThave had an acute illness (as determined by the study doctors), within 72 hours prior to study vaccination.
- ✘ CANNOThave received any antiviral medication within 3 days of study vaccination.
- ✘ CANNOThave any past or current infection with HIV, Hepatitis C, or Hepatitis B.
- ✘ CANNOThave any use of investigational drugs or vaccines within 30 days before starting the study.
- ✘ CANNOThave any chronic use of steroids or other medications that affect the immune system within 6 months of study entry and during the study period.
- ✘ CANNOThave surgery between enrollment and the end of the study.
- ✘ CANNOThave any active alcohol or drug abuse.
- ✘ CANNOThave history of active/recent cancer still within treatment or active surveillance follow-up (except basal cell carcinoma of the skin and cervical carcinoma in situ). Treated/resolved cancers with no likelihood of recurrence may be deemed acceptable at Pr
- ✘ CANNOTbe a recipient of antibodies or blood products within four (4) months before enrollment.
- ✘ CANNOThave a history of Diabetes mellitus (type I or II), with the exception of gestational diabetes.
- ✘ CANNOThave any other physical or psychologic condition or laboratory abnormality that the study doctor thinks may increase your risk of having side effects or compromise the results of the study.
- ✘ CANNOTbe unwilling to allow storage and use of blood for future hantavirus-related research.