Current Studies

Dengue Vaccine Study for 18-45 Year Olds

PURPOSE: Dengue fever is caused by infection with the dengue virus. The virus is transmitted from human to human by mosquitoes. Infection with a dengue virus can result in a range of symptoms, from subclinical disease to debilitating but transient dengue fever to life-threatening dengue hemorrhagic fever (DHF) to dengue shock syndrome (DSS). An estimated 36 million cases of dengue fever occur annually, which results in around 2.3 million cases of DHF and an estimated 20,000 deaths, primarily in children. Dengue is considered the most serious vector-borne disease in children, especially in countries in Southeast Asia, where more than 50% of all dengue cases and dengue related deaths occur in children below the age of 15 years. However, adults are also frequently at risk and, in some areas, have a greater incidence of disease than children. Mosquito control efforts in endemic areas have been ineffective in preventing dengue outbreaks or in preventing further geographical spread of the disease. Since World War II, the four dengue viruses have spread worldwide and are endemic in Asia, Central and South America including Colombia, the Caribbean, the Pacific Islands, and parts of Africa and Australia. Clearly, there is a need for a safe and effective vaccine that will protect against dengue infection. – Enrolling Now

Rotavirus Vaccine Study for 2 Month Olds

PURPOSE: Both RotaTeq® and Rotarix® are licensed in the US, and it is expected that health care providers will administer both vaccines. A 3-dose regimen is recommended for RotaTeq® and a 2-dose regimen for Rotarix®. From previous experience, it is likely that one of the vaccines may become unavailable for some period or pediatric offices may switch from one vaccine to the other. Thus, it is probable that mixed schedules will be administered to infants. This study is designed to study mixed schedules of the 2 vaccines. – Enrolling Now

Measles, Mumps, Rubella, Varicella Vaccine Study for 12-23 Month Olds

PURPOSE: A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made with an Alternative Manufacturing Process (AMP). – Enrolling Now

Herpes Zoster (Shingles) Vaccine Study

PURPOSE: The purpose of this study is to learn about the safety and effectiveness of an inactivated (not live) experimental herpes zoster vaccine in people with certain cancers. Zoster (HZ), or shingles, is a reactivation of the virus varicella which initially causes chickenpox. Following a chicken pox infection, the virus remains dormant in the nervous system until it reactivates, producing HZ. HZ is usually characterized by a painful, blistery skin rash. People with a lowered immune system have a higher chance of HZ, compared to the general population, and are at increased risk for developing severe and life-threatening complications. The only vaccine right now for shingles is a live vaccine and people who have lowered immune system should not take this vaccine. – Enrolling Now

Cytomegalovirus (CMV) Vaccine Study for Teenage Girls

PURPOSE: The purpose of this study is to learn about the safety and protection of an experimental CMV vaccine. CMV is a common virus that causes mild upper respiratory symptoms with or without fever in healthy people. However, it can cause more serious problems when a mother passes it to her unborn child during pregnancy, and in people with weakened immune system. – Enrollment Closed

Sequential Rotavirus Vaccine Schedules with RotaTeq® and Rotarix® for 2 Month Olds

Hexavalent Combination Vaccine for 2 Month Olds

PURPOSE: The purpose of the study is to test the safety and effectiveness of the investigational vaccine, to assess how the child’s body recognizes and responds against viruses and substances that appear foreign or harmful, to see how well the study vaccine is tolerated in infants, and to ensure consistency across the manufacturing lots, during the production and manufacturing of the study vaccine.

Combination vaccines reduce the number of injections required to complete the recommended Childhood Immunization Schedule in the first two years of life. This study involves an investigational hexavalent vaccine which is being developed to provide active immunization against 6 diseases with the convenience of one injection.- Enrolling Now

Avian Flu Vaccine Study for 18 - 49 Year Olds

PURPOSE: Severe disease in humans due to avian influenza viruses of the H5N1 subtype has raised considerable concern regarding the potential emergence of these viruses in pandemic form . Planning for control of such pandemics is of vital importance, and a cornerstone of this planning is the development of effective vaccines for H5N1. - Enrollment Closed

Meningococcal B Vaccine Study for 11 - 17 Year Olds

PURPOSE: The purpose of this study is to learn about the safety and protection of an experimental Meningococcal B vaccine when given with Gardasil, a licensed vaccine that helps protect against Human Papilloma Virus (HPV) which can cause genital warts. Neisseria meningitidis is a leading cause of bacterial meningitis in infants, adolescents, and young adults in developed countries. In particular, N meningitidis serogroup B (MnB) is responsible for approximately two-thirds of the cases of observed meningococcal infections. Currently, there is no broadly effective vaccine against Meningitis B. Gardasil is a recommended vaccine for the prevention of genital warts, a condition that may lead to cervical cancer. – Enrolling Now

Cytomegalovirus (CMV) Vaccine Study for Teenage Girls

Meningococcal Study for Teenagers

PURPOSE: The purpose of this study is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or Menactra®. The study will also enroll agematched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group. – Enrolling Now

Pneumococcal Vaccine Study for Healthy Two Month Olds

PURPOSE: The purpose of this study is to learn about the safety and protection of an investigational vaccine. Pneumococcal bacteria is a leading cause of meningitis and blood stream infections in infants. It can also cause pneumonia, sinusitis and ear infections. – Enrollment Closed

Fluconazole Prophylaxis for Infants weighing less than 750 grams birth weight

PURPOSE: This purpose of this study is to assess whether Fluconazole prophylaxis will decrease death or candidiasis among infants most at risk for candidiasis, those <750g. This study will monitor for safety while on study drug until death or discharge from the NICU. In addition neurodevelopment will be assessed in the surviving infants at 18-22 months. In the premature infant, invasive candidiasis is common and often fatal. Candida species are the third most common etiology of nosocomial blood stream infections in premature infants, and they are associated with the second highest mortality rate. Despite antifungal treatment, 20% of infants who develop neonatal candidiasis die as a result of the disease. Although there have been 2 placebo-controlled studies that showed that prophylaxis reduces invasive candidiasis, most NICUs do not use antifungal prophylaxis because the data are so sparse in premature infants. - Enrollment Closed

Last updated October 2012