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 number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to occur mainly through person-to-person transmission through respiratory droplets, indirect contact with infected people and surfaces. The use of face masks is recommended as a public health measure, but in many settings only domestic cloth made masks are available to the majority of the people. However, masks can be of different quality and very little is known about the utility of cloth face masks at the community level. In Bandim Health Project's Health and Demographic Surveillance System we will evaluate the effect of providing locally produced cloth face masks on severity of COVID-19 like illness and mortality in an urban population. The locally produced cloth mask is made according to a laboratory certified model and will be provided to the intervention group alongside information of how the risk of transmission can be reduced. The control group will receive information alone. Follow-up will be implemented through telephone calls and post-epidemic home visits.
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms. In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.
The world is set on eradicating measles and polio infections in the coming decade. Once both infections are under control, campaigns with measles and oral polio vaccines will be phased out. This might do more harm than good for child survival in low-income countries. Studies from the Bandim Health Project in Guinea-Bissau, and elsewhere, have revealed, that the live measles and oral polio vaccines have beneficial non-specific effects, i.e. effects on child morbidity and mortality unrelated to prevention of the targeted diseases. The campaigns are presumed to be most beneficial for children not reached by routine vaccination programs, as they are not already protected. However, studies show that prior routine or campaign vaccination may boost resistance against unrelated infections. If we phase out measles and oral polio campaigns after eradicating their target infections without considering the impact on child survival, the drastic decline in child mortality since 1990 could change direction. We will conduct the first cluster randomized controlled trial to evaluate the effect of measles and oral polio campaigns on general child morbidity and mortality via the Bandim Health Project. Bandim Health Project runs a Health and Demographic Surveillance System in Guinea-Bissau since 1978 and assesses child health interventions' real-life effects, via continuous registration of all interventions given to all children, and follow-up of individuals. We will conduct the trials in rural Guinea-Bissau monitoring all nine health regions. The hypotheses are: RECAMP-MV: Measles vaccination campaign in Guinea-Bissau reduce morbidity and mortality among children between 9 and 59 months of age by 80% during the subsequent 18 months in a context of limited measles infection. RECAMP-OPV: Oral polio vaccination campaigns in Guinea-Bissau reduce morbidity and mortality among children between 0 and 8 months of age by 25% during the subsequent 12 months in a context with no polio infection. Originally, the trials were meant to be implemented in 182 clusters, enrolling 21000 children. Following revised sample size calculations and discussions with the Data Safety and Monitoring Board, the number of clusters were increased to 222 and the planned number of enrolments increased from 21,000 to 28,000 (RECAMP-MV: 18000, RECAMP-OPV: 10000). To explore the hypothesis that at least part of the beneficial non-specific effects of OPV is driven by changes in the gut and/or respiratory microbiome, we will collect microbiome samples in a sub-group: A nasal swab and a rectal swab will be collected from 50 infants allocated to the intervention group, and 50 infants allocated to the control group. Two sample will be collected for each infant one when recruited for RECAMP-OPV and a second two months later.
This pilot study will test the effect of a cash transfer program aiming to improve family food consumption patterns, family health and schooling, with resulting benefits for childhood growth and cognition.
INTRODUCTION Eight trials studying the effect of providing neonatal vitamin A supplementation (NVAS) have been reported, and another four are underway to test whether NVAS should become WHO policy. Three of the four African trials were conducted by the Bandim Health Project (BHP) in Guinea-Bissau. One of them was a two-by-two factorial trial among low-birth-weight children. From 2004-2008, the children were randomly allocated to 25,000 IU vitamin A or placebo at birth, and furthermore to BCG vaccination at birth or later as is local policy. In 2011, the investigators conducted a follow-up study. A remarkably strong harmful effect of NVAS on atopy and wheezing was found (manuscript under review). Seen in the context that NVAS may soon become a WHO policy it is obviously worrying if NVAS is associated with a higher risk of atopy and wheezing. The investigators therefore aim to conduct a similar follow-up study of participants in the first NVAS trial conducted in Guinea-Bissau from 2002-2004, among normal-birth-weight infants, to test whether NVAS is associated with an increased risk of atopy and wheezing and other allergic symptoms as well as growth. METHODS Study population: From 2002-2004 BHP conducted a randomised trial of NVAS. The investigators recruited newborns when they came for BCG vaccination. Provided parental consent, they received an oral supplement of 50,000 IU vitamin A or placebo. Study design: This study will be a follow-up study of the cohort of children randomised to NVAS (intervention) or placebo (current policy) together with BCG vaccine at birth. Other exposures: The investigators will also investigate the effect of receiving an additional dose of measles vaccine and the timing of DTP vaccine on the development of atopy. Assessment of outcomes: The investigators will visit all children at the last known address. Height, weight and mid upper arm circumference will be measured. BCG scar will be examined and vaccination card details recorded by the field assistant. Children will be excluded from skin prick testing (SPT) if they have a history suggestive of anaphylaxis or are currently using anti-histamine medication. SPT will be performed using aero-allergens, food allergens and positive histamine and negative saline control. The mother or guardian will be interviewed by a local assistant. Symptoms of eczema and asthma as well as food allergy will be assessed. Statistical analysis: Effect of randomisation group and other factors on outcomes will be analysed in multivariable regression models. All analyses will be adjusted for skin prick tester. All analyses will be conducted stratified by sex.
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.
Vitamin A supplementation (VAS) is important for the immune system and may interact with different childhood vaccinations. We have hypothesized that the improved survival after VAS may depend on vitamin A amplifying the non-specific immune modulation induced by vaccinations. In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.
In the present study the investigators wish to address the effects of different doses of vitamin A supplementation in low and normal birth weight infants. Hypotheses: - Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in both normal and low birth weight infants. - A lower dose of vitamin A may be even more beneficial than a high dose.