WRAIR #2725- Phase 2 Hanta PharmaJet Vaccine Trial
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.
- ✔ MUST Be between the ages of 18 and 49 years old.
- ✔ MUST Be willing and able to participate in all planned study visits for the duration of the study.
- ✔ MUST Be in good health.
- ✔ MUST Be 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.
- ✔ MUST agree not to participate in another clinical trial during the study.
- ✔ MUST agree not to donate blood to a blood bank for 3 months after receiving the last study vaccine.
- ✘ CANNOT have any history of having been given a hantavirus vaccine.
- ✘ CANNOT have any serious medical illness or condition involving the heart, liver, lungs, or kidneys.
- ✘ CANNOT have a history of severe allergic reactions.
- ✘ CANNOT have received licensed vaccines within 7 days before or after immunization (30 days for live vaccines)
- ✘ CANNOT have a history of neurologic disease (including migraines or seizures).
- ✘ CANNOT lack 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).
- ✘ CANNOT have 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.
- ✘ CANNOT have had an acute illness (as determined by the study doctors), within 72 hours prior to study vaccination.
- ✘ CANNOT have received any antiviral medication within 3 days of study vaccination.
- ✘ CANNOT have any past or current infection with HIV, Hepatitis C, or Hepatitis B.
- ✘ CANNOT have any use of investigational drugs or vaccines within 30 days before starting the study.
- ✘ CANNOT have any chronic use of steroids or other medications that affect the immune system within 6 months of study entry and during the study period.
- ✘ CANNOT have surgery between enrollment and the end of the study.
- ✘ CANNOT have any active alcohol or drug abuse.
- ✘ CANNOT have 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
- ✘ CANNOT be a recipient of antibodies or blood products within four (4) months before enrollment.
- ✘ CANNOT have a history of Diabetes mellitus (type I or II), with the exception of gestational diabetes.
- ✘ CANNOT have 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.
- ✘ CANNOT be unwilling to allow storage and use of blood for future hantavirus-related research.
WRAIR #2924- Phase 1 RV 575 Vaccine Trial
Researchers are doing this study to test an experimental vaccine for HIV. A vaccine is a medical product given to prevent certain infectious diseases, most often caused by a virus or bacteria (germs). A vaccine may teach the human body to form a defensive response to try to prevent the disease from beginning or taking hold of the body. This defensive response is called an immune response, and is the body’s way to fight infections.
The study also tests a combination of adjuvants. An adjuvant is a substance added to vaccines that can help to make the vaccine more effective by improving the immune response or causing the immune response to last longer than without the adjuvant.
To learn more about the Phase 1 vaccine trial or to enroll, contact the WRAIR Clinical Trials Center at 866-428-2788 or through email.
✔ MUST be a healthy adult between 18-55 years old
✔ MUST sign the consent form
✔ MUST complete the screening process
✔ MUST successfully answer the Test of Understanding (TOU)
✔ MUST be able and willing to comply with all research requirements
✔ MUST weigh at least 110 pounds
✔ MUST be free from HIV
✔ MUST refrain from blood donation during the course of the study
✔ MUST be free of significant medical problems
✔ MUST not pregnant and are willing to take precautions to prevent pregnancy
✔ MUST not plan to travel outside the Washington DC metro area (DC, Maryland, and Virginia) that would prevent compliance with planned study visits
You may not be allowed to participate in this study if any of the following apply to you:
✘ CANNOT have history of HIV or certain other medical conditions
✘ CANNOT have other medical or mental illness that may interfere with your ability to understand the study and give consent to be part of the study
✘ CANNOT have certain other medical conditions such as hepatitis
✘ CANNOT be pregnant or breastfeeding
✘ CANNOT have the results of the screening indicate that you have health problems
✘ CANNOT have a fever on the day of vaccine administration in order to receive the vaccine