Active clinical trials for "Virus Diseases"

This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.

This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.

The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates. This is a randomized, double-blinded, Phase III study. This study is designed to investigate the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg, positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and HBeAb and HBcAb. Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control vaccine respectively. Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10 mcg control vaccine respectively. Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the other 300 subjects will receive 5mcg control vaccine. The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each immunization, safety will be measured by assessment of adverse events through 30 days following each vaccination, serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after last vaccination). For the immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the day 0, 210 and 360 after born.

This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus, which is designed to stimulate an immune response to the virus. The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola virus. Participants are assigned to one of three groups as they enter into the study. Of the first 16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12 receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is safe, the final 12 people in the last group of 16 receive the highest study dose, and 4 receive placebo. The vaccine is given as a single injection in the arm on the day of enrollment. Participants keep a diary for 5 days, recording their temperature, symptoms and any reaction at the injection site. They call a study nurse the day after vaccination to report how they feel, and they return to the clinic approximately six times for follow-up evaluations. These visits may include a check of vital signs, physical examination, blood and urine tests, or other medical tests if needed. ...

The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.

This is an exploratory trial of Bovine Colostrum powder to decrease translocation of gut-derived microbial products and immune activation in HCV infection. The study is designed as a single-arm, open-label, before-and after exploratory trial of 10 weeks of Bovine Colostrum Powder (BCP) to reduce translocation of intestinal microbial products and immune activation in patients suffering from chronic hepatitis C virus (HCV) infection. The study population will include HCV-infected (genotype 1) men and women, ≥ 18 years of age, not receiving anti-viral therapy at the time of enrollment and for at least the previous 3 months. Having failed previous anti-viral therapy (non responders), HCV recurrence after 72 weeks of therapy, developed side effects which mandated stopping anti viral therapy, or not considered eligible for initiation of such treatment, with a plasma HCV RNA level ≥ 1000 I.U.

To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.

In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated 2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses.

Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. In this first-in-human study, evaluation of ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted in healthy adult volunteers.

This is a single-center, randomized, single-blinded study of the Hantaan virus HTNV DNA vaccine alone, Puumala virus PUUV DNA vaccine alone, and mixed Hantaan/Puumala HTNV/PUUV DNA vaccines delivered intramuscularly IM by the needle-free PharmaJet Stratus DSJI device.