There are about 68 clinical studies being (or have been) conducted in Guinea-Bissau. 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.
The propose is to test innate immune training in a pilot study of 40 adults >50 years of age people in Guinea-Bissau. The hypothesis is that BCG vaccination will be associated with increased innate immune training measured as increased cytokine release after in vitro Peripheral Blood Mononuclear Cells (PBMC) stimulation with e.g. Mycobacterium Tuberculosis, Staphylococcus Aureus, Candida Albicans and Streptococcus Pneumoniae.
This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.
The investigators aim to conduct a randomised controlled trial comparing two Bacille Calmette-Guérin (BCG) strains currently used in Guinea-Bissau, the Danish and the Russian, in terms of prevention of neonatal and early life morbidity and mortality, immune responses and adverse events related to BCG vaccination. The primary outcome will be hospital admissions within 6 weeks of age.
Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95% efficacy and was well tolerated and safe. Still, safety could be an issue when the dose of CQ is increased. Severe adverse events are caused by high peak concentrations of CQ. Using split doses of CQ avoids high peak concentrations enabling the safe administration of high doses, however, pharmacokinetic data are lacking. Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse events will be monitored. On day 1, children and their mother/guardian will be requested to stay at the health centre between 9 am and 6 pm. Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the inclusion criteria will be recruited into each study arm. Following the end of treatment, the children will be seen on the morning of day 7, 14, 21 and 28. Any child wishing to withdraw during the treatment phase and any child with reparasitaemia during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine according to treatment guidelines in Guinea-Bissau. Final analysis will include a description of included children, proportions of adverse events and any serious adverse events, drug concentrations and their relation to adverse events, the proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and uncorrected success and failure rates on day 28 and the proportion of early, late clinical and late parasitological treatment failures.
Plasmodium falciparum causes malaria and approximately 665 000 deaths each year. chloroquine and sulphadoxine-pyrimethamine resistant P. falciparum are widespread. An artemisinin derivative combined with lumefantrine, amodiaquine or piperaquine is therefore recommended for the treatment of malaria in Africa. However, artemisinin resistance appears to be developing and resistance/tolerance to amodiaquine and lumefantrine exists. We are presently conducting a study in Guinea-Bissau. Preliminary data indicates that the effectiveness and availability of artemether-lumefantrine (AL), the 1st line drug, is poor. Consequently there is a need for another treatment option. Dihydroartemisinin-piperaquine (DP) has been shown to be efficacious and well tolerated in several African countries and is therefore such an option. A clinical trial comparing the safety and efficacy of artemether-lumefantrine and dihydroartemisinin-piperaquine is therefore needed. Parents to children seeking Bandim Health Centre (CSB) with symptoms compatible with malaria will be informed of the study. If accepting and the child fulfil the inclusion criteria, the child will be randomised to treatment with either AL or DP. The treatment will be given supervised at the health centre in the morning and the evening on day 0, day 1, and day 2. At each visit and in the morning on day 3, the child will be examined, the mother asked for any symptoms and signs of side-effects, the temperature measured. Furthermore, a blood sample will be taken for examination of malaria parasites. On day 0 samples for measurement of antimalarial drugs and for genotyping of the parasites will be taken on filterpaper. In a subgroup of 50 children a blood sample for in vitro culturing and for analysis of the number of leucocytes will also be taken. After having finished the treatment the children will be followed on day 7 and then once a week until day 42. At each visit the condition of the child will be examined and a bloodsample taken for examination of parasites in the blood. Furthermore, a filterpaper bloodsample will be collected for measurement of the drug concentration of if the child has recrudescence for genotyping of the parasites. On day 0, 3 and 42 the haemoglobin level will be examined. The result of the two treatments will be evaluated by comparing the number of children with recurrent parasitaemia, both corrected and uncorrected (recrudescence vs. reinfections). This will be presented as adequate clinical and parasitological response rates PCR-corrected and PCR-uncorrected. Furthermore, the chance in haemoglobin level from day 0 till day 3 and till day 42 will be compared. The concentration of the antimalarial drug in the blood samples taken at the visit before the re-parasitaemia will be capered to the concentrations in children without re-parasitaemia. Assuming a 20% loss to follow up a total of 346 children should be included. For the children included, health care and medications at Bandim Health Centre will be free during the study period but no other gifts or payments will be made. Results will be presented to the staff at the Bandim health centre and the ministry of Health and will be published in an international peer reviewed journal.
The prevalence of asthma and allergic diseases is increasing worldwide. Infections and vaccinations in childhood may have an impact on the subsequent development of asthma and allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Guérin (BCG) vaccine was associated with reduction in atopy. Since then the investigators have conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The present study aims to follow up children enrolled in the BCG randomised trial to assess for asthma and allergy later in childhood. Based on previous observations, the investigators expect children allocated to receive BCG at birth will have a reduction in allergy profile when compared to children who did not receive BCG at birth.
The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts exclusively on children below 12 months of age; children who have reached 12 months of age are no longer entitled to vaccines through the EPI program. This has affected the measles vaccination coverage, approx. 30% of the children in the rural area do not receive measles vaccine (MV). Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on survival, reducing mortality by approximately 50% - far more than can be explained by prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on survival, and the current policy may have important consequences for overall child mortality. To test the implications of the current policy of only vaccinating children below 12 months of age, the investigators will conduct a cluster randomized trial, in which children will receive their vaccines according to the current national EPI policy (National policy) or receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy). The investigators hypothesise that among children enrolled after 12 months of age, mortality is 50% lower in children randomised to receive MV compared with children randomised to follow the national policy and not receive MV.
Diarrhoea is the leading cause of death in the world with 2.2 million deaths every year. The majority of deaths are among children in developing countries, but the travellers encounter the disease as well. The studies on the aetiology have suffered from serious methodological deficiencies and the results are even controversial. At the same time, the current diagnostic methods are inadequate. The investigators have recently developed novel multiplex RT-PCR methods to cover the majority of diarrhoeal pathogens. The present study is a collaboration between Finland and Sweden/Guinea-Bissau. The aim is to characterize the causative agents of diarrhoea (a) in Finnish volunteers before and after a travel to tropical areas and, (b) in inhabitants of endemic areas in Guinea-Bissau. For these purposes stool samples will be collected from volunteers of different age groups and from healthy volunteers as well as those with diarrhea both in Guinea-Bissau and in Finland. In addition to pathogens, other intestinal microbes and antimicrobial resistance will be investigated
BACKGROUND: Since 1996 the combination of three or more drugs has been the mainstay of human immunodeficiency virus (HIV) treatment. The most important types of drugs are called nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleotide reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) Response to treatment is measured as increasing CD4+ cell count and decreasing HIV viral load. A major problem is the development of resistance. NNRTIs are recommended as part of first-line treatment of HIV in Africa but many Africans have a slower NNRTI clearance than Caucasians making them more susceptible for development of resistance in case of treatment interruptions. PIs might therefore be a better option in an African setting with low adherence. AIM: To evaluate two different treatment regimens in HIV-1 infected patients: A) A NNRTI (efavirenz/nevirapine) based regimen and B) A PI (ritonavir-boosted lopinavir) based regimen with regard to treatment outcomes. HYPOTHESIS: Treatment with a PI will be superior to treatment with a NNRTI due to less development of resistance. METHODS: Treatment-naïve adult HIV-1 patients enrolled in an existing cohort The West African Retrovirus and Acquired Immune Deficiency (WARAID) cohort in Guinea Bissau with CD4+ cell count ≤ 350 cells/µL and/or clinical signs of immune suppression (World Health Organization (WHO) clinical stage 3 or 4) will be randomised 1:1 to: Treatment A: 2 NRTIs (lamivudine and either zidovudine or stavudine) and 1 NNRTI (efavirenz or nevirapine) or Treatment B: 2 NRTIs (same as in treatment A) and 1 PI (ritonavir-boosted lopinavir). Primary outcome: Viral load suppression <400 copies/ml 12 months after enrolment. PERSPECTIVES: Guidelines for treatment of HIV in Africa are more or less a copy of the guidelines used in Europe and North America. Genetic differences in pharmacokinetics, more women infected in Africa and difficulties ensuring good adherence mean that results obtained from Caucasian patients are not directly transferrable to African patients. The results of this study will hopefully help guiding the treatment of HIV in Africa in the future. The investigators believe the HIV infected people in West Africa deserve the same evidence-based medicine as in developed countries.
The routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will be included in a follow-up study. The genetic basis of the parasites for developing resistance will be examined. In case of reappearance of parasites the child will be re-treated following the guidelines of the national malaria programme.