There are about 12 clinical studies being (or have been) conducted in Fiji. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Lymphatic Filariasis (LF), scabies and soil transmitted helminths (STH) are common neglected tropical diseases affecting the people of Fiji. There is a dedicated LF eradication program supported by the World Health Organization (WHO), however scabies and STH are currently managed on an individual level with symptomatic treatment as required. In an attempt to reduce the prevalence of LF globally, research is being undertaken into alternative, more effective treatment options. A recent study in Papua New Guinea demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole) used by WHO LF programs in the Pacific. However, adverse events were more frequent. Despite no serious adverse events being observed, it is necessary to conduct further studies to review the safety of this new triple therapy before it can be endorsed as an effective mass drug administration (MDA) regimen for LF in endemic countries. Fiji's burden of LF, that has been recalcitrant to previous MDA with diethylcarbamazine and albendazole, make it an ideal site to obtain further efficacy and safety data of the triple therapy. Ivermectin given to communities as MDA has been proven to be effective in reducing the community prevalence of scabies. What is not known is the effects of one dose versus two doses of ivermectin as MDA. This question will be reviewed within the design of the community randomized study. The prevalence of impetigo in a community is linked to scabies and this will also be reviewed. Ivermectin and albendazole are both effective individually against STH. The effectiveness of this combination of treatment as MDA in Fiji for STH has not been studied. The effectiveness for the individual in the short-term and the community in the longer-term will be reviewed. In addition, the acceptability and feasibility of the new therapy in communities at risk of these three diseases will be reviewed.
In Fiji, cervical cancer is the second most frequent cancer and the highest cause of cancer mortality in women. In 2008/9, the Ministry of Health in Fiji accepted a donation of 110,000 doses of quadrivalent HPV vaccine, Gardasil® based on the high cervical cancer disease burden. There was enough vaccine to vaccinate all girls aged 9-12 years (30,338 girls) with a three-dose schedule, but not all girls received three doses of the vaccine. This means those girls that received reduced doses may not be fully protected against the HPV genotypes present in the Gardasil®. While HPV vaccines are highly immunogenic and efficacious in the licensed three-dose schedule, there is limited information about the effectiveness of reduced dose schedules in terms of immunogenicity and memory. There is growing evidence from other studies that two doses of HPV vaccine may be sufficient for protection. Reduced schedules would be of benefit in Fiji due to improved costs and logistics. This study will examine whether one or two doses of HPV vaccine provide similar immunological evidence of long-term protection to the standard three-dose schedule in terms of antibody titres to the genotypes present in the Gardasil®. To compare immunological memory responses between dosage groups, a dose of Cervarix ® will be administered to all girls so that the magnitude of the memory responses can be measured.
The purpose of this study is to investigate whether there are genetic differences between patients with rheumatic heart disease and members of the general population.
Group A streptococcus (GAS) is a bacteria that causes many different sicknesses in children and adults. This study will look at the number of cases of pyoderma (bacterial skin infection) and scabies (skin mites that cause itching) in 550 infants 12 months or younger in Fiji. (GAS can cause pyoderma, and sometimes skin sites infested with scabies can become infected with GAS bacteria.) The study will also look at the makeup of GAS and how certain medications affect GAS. The infants will be involved in the study for approximately 1 week. Their skin will be examined for pyoderma and scabies. A swab sample will be taken from the pyoderma area to test for GAS. The researchers hope to see how often these skin infections occur and how they affect the Fijian population. The information will help the researchers to develop better treatment and possibly a vaccine to prevent infection. Infants with pyoderma that is defined as "greater than mild" will be referred for treatment.
The purpose of this study is to find out how often group A Streptococcus (GAS) occurs in school-age children of Central Fiji. This bacterium often causes pharyngitis (sore throat) and can also cause pyoderma (skin infection) or scabies. Approximately 1000 children ages 5-14 years will be enrolled from 4 primary schools in Central Fiji. These children will have throat swabs performed to determine how commonly GAS occurs. Over the next 10 months, children in this group who complain of sore throat will be examined and have throat swabs to determine if GAS is the cause. A subset of 600 children will be examined for pyoderma and scabies and have throat swabs every 2 months during the 10 month study. In addition, a small amount of blood will be drawn at 0, 6, and 10 months to determine the level of antibodies to Streptococcus.
The purpose of this study is to estimate the number of cases of rheumatic heart disease, pyoderma, and scabies in school age children in Fiji. In addition the study will describe the features of rheumatic heart disease, pyoderma, and scabies in these children. Study participants will include 5200 primary school children, ages 5-14, from 21 primary schools in the Central Division of Fiji. These children will be examined for pyoderma, scabies, and the doctor will listen to their heart with a stethoscope. Any child that has a heart murmur detected will have their heart looked at through an echocardiogram test (uses sound waves to create a picture of how the heart is working). Any child that is found to have rheumatic heart disease will be referred to a pediatric cardiologist for further evaluation. Participants will be involved in the study for about 2 days.
The purpose of this ongoing study (Part V) is to evaluate the cause, distribution, control, and results of group A streptococcus infections (GAS) in Fiji. Patients of all ages presenting to the Colonial War Memorial Hospital, Suva, Fiji and patients donating blood to the Colonial War Memorial Hospital, Suva, Fiji may participate. Subject duration is less than one day. This study may help to develop a vaccine that will prevent group A streptococcal infections.
The purpose of this ongoing study (Part II) is to estimate the incidence of acute rheumatic fever, rheumatic heart disease, acute post-streptococcal glomerulonephritis (kidney disease), and invasive group A streptococcal (GAS) disease (strep infection) in Fiji to help develop better treatments and vaccines. Group A streptococcal disease is caused by the bacterium group A streptococcus. It is commonly found in the nose and throat of normal healthy adults and children, and can cause illness. The bacterium is spread by close contact with patients or carriers, through things like coughing, sneezing, kissing, or sharing a drink and can cause a wide variety of illnesses. These illnesses may be a sore throat, skin sores, and less commonly acute rheumatic fever or kidney disease. Participants of all ages will be recruited through the Colonial War Memorial and Lautoka Hospital. A blood sample will be collected from each study participant. Subject participation should be less than one day.
Pneumonia is the most common reason for admission of Fijian children to hospitals. The most common germ causing pneumonia is "streptococcus pneumoniae." It is a common cause of meningitis (infection around the brain and spinal cord), ear infections, and blood infections and it lives in the nose of humans. A vaccine has been developed that will help prevent these common diseases but prevents only about one quarter of pneumonia cases and it is expensive. This study explores new ways of giving this vaccine that are affordable, safe, and effective in countries such as Fiji. About 550 Fijian infants presenting at 6 weeks of age, for their first diptheria, tetanus, toxoid, pertussis vaccine immunization, to one of the participating Health Centers or Colonial War Memorial Hospital in urban Suva, Fiji will be enrolled. Children will remain in the study for 2 years. Study procedures include full vaccination against 7 types of pneumococcus, blood tests, and nasal swabs.