This research is to study a new vaccine for the prevention of invasive Salmonella disease. Salmonella is caused by germs (bacteria) called S. Typhi (Typhoid, for short) or S. Typhimurium and S. Enteritidis (together referred to as Non-Typhoidal Salmonella or NTS, for short). Infection with Typhoid and NTS is from contaminated food or water. Typhoid and NTS infections are a major problem in developing countries. In the U.S., there are occasional outbreaks of NTS infections with imported foods
The main purpose of this research is to test the safety and measure the immune response of the Trivalent vaccine over a range of doses.
The vaccine is investigational, which means the Food and Drug Administration (FDA) has not approved it for use by the general public, but the FDA is allowing the use of the vaccine for research in this study. There is a placebo being used in this study.
You may qualify for this study if you are healthy and satisfy all the entry conditions of the study. We anticipate speaking with approximately 300 potential volunteers about this study. Of those 300 potential volunteers, we anticipate that approximately 200 volunteers will sign an informed consent form in order to be screened to see if they are eligible for this study. Of those 200 screened volunteers, we anticipate that approximately 96 volunteers will continue on to be vaccinated in this study.
The following are some of the criteria to be eligible for this study:
· You must be 18 to 45 years of age, inclusive
· You must provide written informed consent
· You must be healthy as established by vital signs, medical history, laboratory evaluation and screening evaluations including clinical physical examination.
· You must be available for all study visits.
· If female, you must not be pregnant or breastfeeding. You must be of non-childbearing potential (defined as surgically sterile or postmenopausal for more than 1 year), or, if of childbearing potential, you must be practicing abstinence or using an effective licensed method of birth control (e.g., history of hysterectomy or tubal ligation; use hormonal or barrier birth control such as implants, injectables, oral contraceptives, some intrauterine devices (IUDs), condoms with spermicidal agents; or must have a vasectomized partner) from 28 days before enrollment until at least 28 days after the last vaccination. A woman is eligible if she is monogamous with a vasectomized male.
· You must agree not to participate in another clinical trial at any time during the study period.
· You must agree to allow for the indefinite storage of blood samples for future research use.
· You must not have a history of typhoid vaccination or known history of typhoid infection within 5 years.
· You must not have had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
· You must pass a written examination during screening (70% correct answers required to pass).
· You must not have received an experimental agent (vaccine, drug, device, etc.) within 28 days before enrollment or expect to receive an experimental agent during the study period.
· You must not have received any licensed vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) before enrollment in this study.
· You must not have a known sensitivity to any ingredient in the study vaccine, including a history of severe allergic reaction to tetanus vaccine.
· You must not have received immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
· You must not have immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
· You must not have any long-term use (>2 weeks) of oral or injectable steroids (glucocorticoids), or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).