There are about 94 clinical studies being (or have been) conducted in Gambia. 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.
Objectives: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers. Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.
Malaria in African countries remains an important cause of mortality and morbidity among young children. The global malaria control strategies include prompt treatment with an effective antimalarial drug, vector control using ITNs or curtains, indoor residual spraying (IRS), and intermittent preventive treatment. However, individually these interventions provide only imperfect protection. Thus, there is a need to investigate whether additional control measures provide added benefit in reducing mortality and morbidity. Therefore, 1312 children under 5 years of age living in villages and hamlets near Farafenni, The Gambia, which form part of the rural Farafenni Demographic Surveillance system (FDSS) in North Bank Region(NBR) were randomly allocated to receive IPTc or placebo from village health workers based in primary health care villages. Treatment with a single dose of sulfadoxine /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at monthly intervals on three occasions during the months of September, October and November. In addition, VHWs were trained to administer treatment with coartem to children if they develop symptoms compatible with malaria during the malaria transmission season. The primary end point was the incidence of clinical attacks of malaria detected during the study.
Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without compromising the development of malaria immunity or encouraging drug resistance. The effect of IPT in children in the prevention of malaria has been evaluated in a number of trials in areas of seasonal malaria transmission. Results from these trials have shown that IPTc provided between 40% - 86% protection against clinical malaria. In 2006, a trial that compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia. Preliminary results of the trial have shown that the treatment was very effective as only 4% (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic. Tolerability was assessed in a subset of 1100 children and the results showed that about 13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of the study subjects. Severe adverse events were rare. Thus it is important to investigate if other drug regimens might be equally effective in preventing malaria but less likely to cause adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions during the months of September, October, and November. To determine the prevalence of side effects following drug administration participants in each treatment group will be visited at home three and seven days after each round of drug administration and a side effects questionnaire completed. To help establish whether these adverse events are drug related, the same questionnaire will be administered after each treatment round, to 286 age-matched children who are not part of the trial. The primary ends points will be the incidence of adverse events.
Drug resistance to a range of antimalarial treatments has become widespread in Africa, South East Asia and South America. Because the rapid spread of drug resistance threatens a public health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria policy of using Artemisinin-based combination therapies (ACT), there is a need to develop new, safe, effective and affordable ACT. Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment of uncomplicated falciparum malaria in Africa.
This study is preliminary to proving that this vaccine could protect against tuberculosis in humans. Although there is no proven data to show that infants will benefit directly from participation in this study by being protected against TB, MVA85A protection of mice, guinea pigs and monkeys against tuberculosis is encouraging. It is hoped that the information gained from this study will contribute to the development of a safe and effective TB vaccine for HIV negative and positive individuals. Participants in this study will benefit by having information about their general health status, and the rigorous follow up visit that could enhance early detection and management of medical conditions that might arise in the course of the study.
H. pylori infection causes the stomach to become inflamed. The problem usually begins in childhood and leads to stomach problems in adult life. Study participants will be residents of The Gambia, West Africa, and will be studied at the Medical Research Council of Great Britain facility in Fajara, The Gambia. Up to 75 adults 18 years and older and 20 malnourished children 6 months to 2 years of age, who are undergoing endoscopy as part of their medical care, will be studied. (Endoscopy is when a thin, lighted device is used to look inside the body.) During this study procedure, tiny pieces of tissue, called biopsies, will be taken from the stomach and checked for H. pylori infection. Participants found to be infected will be given antibiotic treatment. Participation in the study will last approximately 72 hours.
A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers
The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.
The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.
Antimalarial chemoprophylaxis can reduce morbidity and mortality from malaria in children. However, this approach to malaria control has not been implemented widely because of concerns over its possible effect on the development of resistance and natural immunity. Intermittent preventive treatment (IPT) may be able to achieve some of the beneficial effects of chemoprophylaxis without its drawbacks. Recently, it has been shown that IPT given to Senegalese children under the age of five years on three occasions during the malaria transmission season reduced the incidence of clinical malaria by approximately 90%. However, it is uncertain how this intervention can be most effectively delivered. Therefore, 26 Maternal and Child Health (MCH) trekking clinics in Upper River Division, south of the River Gambia, each with an average catchment population of 400-500 children under 5 years of age, will be randomly allocated to receive IPT from the MCH trekking team or from a IPT dispenser (village health worker, traditional birth attendant or a community mother based in a primary health care village). Treatment with a single dose of sulfadoxine /pyrimethamine (SP) plus three doses of amodiaquine will be given to all study subjects at monthly intervals on three occasions during the months of September, October and November. The primary end points will be the incidence of clinical attacks of malaria detected by passive case detection, and cost-effectiveness of the delivery methods. Important secondary endpoints will be the coverage and the equity of coverage of IPT in preventing malaria morbidity.