Active clinical trials for "Smallpox"

This study will examine the safety of an experimental medication called Poly-ICLC, developed for preventing or reducing the severity of infections from influenza and other viruses acquired through the nose, mouth and lungs. The study is divided into two parts, in which Poly-ICLC is tested at different dose levels. Healthy people between 18 and 70 years of age who have no chronic medical problems may be eligible for this study. Participants undergo the following procedures: Part I Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. Day 1: Nasal wash and Poly-ICLC administration. A small amount of salt water is placed into the front of the nose and then suctioned out. Poly-ICLC is then squirted into each nostril, one after the other, at a dose of 0.25, 0.5 or 1 mg. A small number of subjects are given a placebo (a solution with no active ingredient.) Subjects are observed in the clinic for 30 minutes after treatment. Day 2: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects. Day 5: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks. Day 12: Subjects are contacted by phone to review their diary card. Day 28: Subjects are contacted by phone to review their diary card. Part II Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests. Day 1: Nasal wash and Poly-ICLC administration. Same as above for Part I participants. Day 3: Subjects receive a second dose of medication and are observed again for 30 minutes. Day 4: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects. Day 7: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks. Day 14: Subjects are contacted by phone to review their diary card. Day 28: Subjects are contacted by phone to review their diary card.

This study will test the safety of an experimental vaccine called modified vaccinia virus ankara (MVA) and determine if it confers protection against the smallpox virus (variola). There is an existing vaccine, called Dryvax® (Registered Trademark), which is effective against smallpox; however, this vaccine can cause various side effects, including some that, on rare occasions, can be life-threatening. Dryvax® (Registered Trademark) has not been used in the United States since childhood vaccination was stopped in 1971, and though it is given to certain healthcare and laboratory workers, and some people in the armed forces, it is not recommended for the general population. Both the MVA and Dryvax® (Registered Trademark) vaccines are made using the vaccinia virus, which is closely related to variola. Healthy normal volunteers between 31 and 60 years of age who have been vaccinated with a smallpox vaccine more than 10 years before entering the study may be eligible for this protocol. Candidates will be screened with a medical history, physical examination, and blood and urine tests, including an HIV test and a pregnancy test for women of childbearing potential. Participants will receive MVA vaccine or placebo, followed by a dose of Dryvax® (Registered Trademark). The MVA vaccine and placebo are injected into an arm muscle with a needle and syringe. The Dryvax® (Registered Trademark) vaccine is administered with a special forked needle that is poked lightly into the skin of the upper arm, usually 15 times, in a process called scarification. When the vaccine works, a small pus-filled blister forms, followed by a scab and then scarring at the site of the vaccination. The formation of the blister and scab is called a take, indicating that the vaccine is effective and will protect against smallpox for at least a few years. If scarification does not take, it can either mean that the person already has immunity or that the vaccine did not work. Study participants will be randomly assigned to one of the following dosing groups: 1) one injection of MVA; 2) one injection of placebo; 3) two injections of MVA 4 weeks apart; or 4) two injections of placebo 4 weeks apart. All participants will receive a challenge dose of Dryvax® (Registered Trademark) 12 weeks after their last injection of MVA or placebo to determine if the MVA vaccine has conferred immunity. A take, that occurs in response to the Dryvax® (Registered Trademark) dose indicates lack of prior immunity, and thus tells whether one or two doses of MVA is needed to produce an immune response. Participants will be observed for at least 1 hour after each injection. They will come to the clinic at least once a week after MVA or placebo injections and at least twice a week after Dryvax® (Registered Trademark) to have the injection site evaluated and photographed. At each visit, participants will be asked how they are feeling and what medications, if any, they are taking. Blood and urine tests will be done according to the following schedule: Before each injection; 1 week after each injection; 4 weeks after the MVA or placebo injections are finished; At the time of the Dryvax® (Registered Trademark) dose; 4 weeks after the Dryvax® (Registered Trademark) dose; 12 weeks after the Dryvax® (Registered Trademark) dose. Additional laboratory tests may be done between visits if medically necessary.

The Aim: To study safety, tolerability and pharmacokinetics of NIOCH-14 when administered orally using a set of clinical and laboratory-instrumental methods. The research tasks are to: to assess the safety and tolerability of different single doses of the drug; to assess the safety and tolerability of different repeated doses of the drug; to study pharmacokinetics of single and repeated administration of the drug; to assess the data on safety and tolerability to select the optimal drug dosing schedule to resolve the issue of conducting phase II clinical trial in an expanded cohort of volunteers.

This study is designed to evaluate the immunogenicity profile of JYNNEOS® when 2 doses are administered subcutaneously (SC) 4 weeks apart; and potential immunological interference while concomitantly administering TPOXX or placebo orally twice daily (BID) for 28 days.

The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.

The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection

The main purpose of this clinical trial is to generate additional safety data in a highly immunocompromised population. HIV-infected persons are considered excellent candidates to represent the highly immunocompromised population for enrolment in this trial. Additionally, the immune system's response (protection against smallpox as measured by the amount of antibodies produced) following injections of MVA-BN® smallpox vaccine will be evaluated. All participants in this trial will be randomly and evenly assigned to one of three groups to receive two, three or four injections. Group 1 will receive the standard regime consisting of one dose at each vaccination time point, Group 2 will receive two doses at each vaccination time point and Group 3 will receive a booster vaccination 12 weeks after the standard vaccination schedule with MVA-BN® smallpox vaccine. Participation in the trial is scheduled to last up to 75 weeks.

A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects

The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.

The purpose of this study is to assess the take rate (formation of a typical postvaccinal lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.