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.
Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular immunity against HIV-1. Target group: Untreated healthy individuals with chronic HIV-1 infection. Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine. The secondary purpose is to evaluate the clinical effect of the vaccination treatment as measured by induction of immunity, lowering of viral load, induction of escape mutations in the virus and improvement in the patient CD4 lymphocyte blood counts. The third purpose is to evaluate the feasibility of conducting a therapeutic HIV immunization study in a poorly-resourced African setting. Design: The experiment is designed as a blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in West Africa. Numbers of individuals: Phase I: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls).
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 have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.
Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.
We observed in a randomised intervention trial in Bissau that mortality due to malaria could be reduced by half by adding a small monetary incentive to the staff and strict follow-up of a standard protocol for available drugs. The Government and donors are not able to sustain such incentives. We intend to evaluate whether strict organisation of a cost recovery system and the use of part of the funds for staff incentives would improve performance of the staff and contribute to reduction of hospital and post-discharge mortality.
Our group has consistently found that the major interventions to reduce morbidity and mortality in low-income countries have sex-differential effects. These interventions include BCG vaccine, oral polio vaccination (OPV), and vitamin A supplementation (VAS). Low-birth-weight (LBW) children constitute the largest high-risk group in low-income countries. According to current policy, they receive OPV at birth. Current evidence suggests that a policy of providing BCG with OPV for girls and VAS instead of OPV for boys at birth may improve survival in LBW neonates. This will be tested in a large randomized trial. We experienced an unexpected cluster of deaths among boys in the VAS arm, which could be due to chance, but we decided to stop randomizing boys to OPV or VAS. Very recent evidence has suggested that low-birth-weight boys may benefit from BCG at birth as well. Hence, we have obtained ethical permission to continue the trial with randomization of boys to OPV or OPV plus BCG.
High-dose vitamin A to children above 6 months of age reduces all-cause mortality by 23-30%. The WHO recommends vitamin A supplementation (VAS) with the first vaccine after 6 months of age. However, the effect of providing VAS with vaccines has never been investigated. We have hypothesised that the effect of VAS depends on the immune stimulus at the time of supplementation. Hence, the effect might vary depending on which type of vaccine it is given with. In particular, we hypothesised that VAS might be beneficial when given with measles vaccine but not when given with DTP vaccine. Normally the first vaccine after 6 months of age would be a measles vaccine, but many children come late for their DTP vaccinations and receive DTP alone or together with measles vaccine. Hence, it is important to study whether the effect of VAS is the same irrespective of the vaccine(s) administered at the same time. Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with vaccines, but plans to do so within the next years. Together with the Ministry of Health in Guinea-Bissau, the Bandim Health Project (BHP) in Guinea-Bissau will investigate the effect on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau. This will be done in a large randomised trial. BHP has a demographic surveillance system (DSS) which has followed a population of now more than 150,000 individuals for almost 30 years. Children will be randomised to receive VAS or placebo with their first vaccine after 6 months of age, and will be followed through the DSS to assess mortality and morbidity. Based on previous observations, the effects of VAS might differ according to sex and season. The interaction between VAS, sex, and season will also be studied in the present trial. By identifying situations where VAS may be beneficial, ineffective, or even harmful the study may contribute importantly to optimising the VAS policy for low-income countries.
The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.
Low body temperature (hypothermia (HT)) at birth contributes to infant mortality in low-income countries. A study from Guinéa-Bissau indicates that HT results in an increased mortality rate, which persist at least two months after birth. Therefore interventions that reduce the prevalence of HT might have a significant effect on infant mortality. The purpose of the proposed study is to identify risk factors for HT in an in-hospital setting in Guinea-Bissau and to investigate whether continuous temperature-monitoring enabling early detection of HT and treatment can prevent HT <34,5°C.
This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau. The genetic basis of the parasites for developing resistance will be examined. Children coming to one of the Health Centres with symptoms of malaria and a positive malaria test will be included. The children will be followed weekly until day 70. In case of reappearance of parasites the child will be re-treated with the opposite study drug.
In non-randomized studies, routine childhood vaccinations have been observed to have non-targeted effects. Difteria-tetanus-pertussis (DTP) vaccine provided with or after measles vaccine (MV) is associated with increased mortality in areas with herd immunity to pertussis. We will examine in a randomised study of 6000 children the effect of not administering DTP simultaneously with or after MV on overall child mortality, hospitalization rates, and the immunological responses after vaccination. We will also examine potential sex-differential effects in the outcomes and interactions with other vaccines, other health interventions and season.