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90 active trials for Malaria

Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda

BCG vaccination may have non-specific effects (NSE) i.e., additional benefits on childhood morbidity and mortality that are separate the vaccine's effect on the incidence of disseminated tuberculosis. Though the available literature is mostly from observational study designs, and is fraught with controversy, BCG vaccination at birth, in a high risk population of HIV exposed children, may protect infants against serious infections other than TB. Yet, other studies indicate that giving BCG later in infancy, when the immune system is more mature, may offer even greater protection. The appropriate timing of BCG vaccination could therefore be up for revision. This study will therefore compare BCG vaccination at birth with BCG vaccination at 14 weeks of age in HIV exposed (HE) babies. Methods: This is an individually randomized clinical trial in 4,500 HIV exposed infants. The intervention is an intra-dermal administration of 0.05 ml of BCG vaccine within 24 hours of birth while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine at 14 weeks of age. The main study outcomes include: Severe illness in the first 14 weeks of life, TNF, IL-1b, IL-6 and IFN-? in response to mycobacterial and non-mycobacterial antigens and Severe illness in the first 14-52 weeks and 0-52 weeks of life. The study will be carried in two health Center IIIs and a health center IV in Uganda. Implications: A well-timed BCG vaccination could have important additional benefits in HE infants. This trial could inform the development of programmatically appropriate timing of BCG vaccination for HE infants.

Start: July 2016

Mass Drug Administration of Ivermectin and Dihydroartemisinin-piperaquine as an Additional Intervention for Malaria Elimination

This is a community-based cluster-randomized trial in which a novel approach to interrupt residual malaria transmission by mass drug administration (MDA) with ivermectin (IVM) combined with dihydroartemisinin-piperaquine (DP) will be tested. This cluster-randomized trial will involve 32 villages in the Upper River Region of The Gambia that will be randomized to MDA with IVM and DP or to standard of care in a ratio 1:1. This trial aims at establishing whether MDA with IVM and DP can reduce or interrupt malaria transmission in medium to low transmission settings by reducing vector survival and the human reservoir of infection. MDA with IVM and DP will be implemented in the intervention villages and all human settlements in the buffer zone, with the aim of minimizing spillover effects. Control clusters will receive standard malaria control interventions as implemented by the National Malaria Control Program. The primary outcomes will be the prevalence of malaria infection determined by molecular methods in all age groups at the peak of the second transmission season (November-December 2019) and the vector's parous rate 7-14 days after MDA.

Start: August 2018

Feasibility, Acceptability and Costs of a Multiple First-lines Artemisinin-based Combination Therapies

A simultaneous deployment of multiple first line therapies (MFT) for uncomplicated malaria using artemisisin based combination therapies as showed by theoretical models, may extend the useful therapeutic life of the current Artemisinin-based combination thérapies (ACTs) by reducing drug pressure and slowing the spread of resistance without putting life at risk. We therefore hypothesized that a simultaneous deployment of three ACTs targeting three segments of the population is feasible, acceptable and can achieve high coverage rate if potential barriers are well identified, well addressed and the key implementers are well-trained and adequately supported. To test this hypothesis, a quasi-experimental study will be conducted.

Start: November 2018

Biomarkers of P. Vivax Relapse

Plasmodium vivax malaria is difficult to manage because even after taking medicine that kills the infection in the blood, it can continue to hide quietly in the liver, later re-emerging into the blood and causing another episode of malaria illness (relapse). This clinical trial aims to enroll patient with P. vivax infections and try to detect signals in blood, urine and/or saliva coming from the silent liver stages to help identify who could benefit from treatment with primaquine. It also will explore if certain factors of patients negatively impact primaquine efficacy.

Start: November 2019

Improving Maternal heAlth by Reducing Malaria in African HIV Women

Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylaxis (CTXp) and antiretroviral (ARV) drugs and using long lasting insecticide treated nets will be conducted in Mozambique and Gabon where malaria and HIV infection are moderate to highly prevalent. In addition, the possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.

Start: September 2019

Assessing the Impact of Group Antenatal Care on IPTp Uptake in Tanzania

Group antenatal care (GANC) is a service delivery model where women with pregnancies of similar gestational age are brought together for antenatal care (ANC), incorporating information sharing and peer support. This model provides selected aspects of clinical care to women in the group at the same time during group visits, as well as creating a support group of women at a similar stage in pregnancy, to improve the quality of care and engagement of women in the ANC process, ultimately leading to better retention in care. Initial studies have suggested that this improves uptake of intermittent preventive treatment in pregnancy (IPTp) among women who participate, but have not evaluated the effect at community level. The investigators propose to assess whether use of the GANC model in Tanzania can improve the quality of ANC as compared to standard individual ANC, by measuring uptake of recommended interventions, primarily IPTp. Recent data from Tanzania and Kenya suggest that malaria parasitemia prevalence among pregnant women correlates with the prevalence among children under five, and could be used to track trends over time.3-5 The very high coverage of ANC (>80% attending at least one ANC contact), suggests that pregnant women could be a good sentinel population that could be readily tracked over time. However, pregnant women represent only about 5% of the overall population, thus, it is important to demonstrate that the trends in malaria prevalence and household level coverage of interventions reported by pregnant women attending ANC is representative of coverage among the general population. If validated, these data could be used to augment or even replace the data on coverage of interventions collected through the use of malaria indicator surveys, which are expensive and infrequently conducted, and generally only powered to the regional level.

Start: November 2019

Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali

Background: The disease malaria affects many people in Mali and other parts of Africa and the world. It is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious or lead to death if it is not treated promptly. Researchers want to find a safe vaccine that prevents malaria. Objective: To study how safe and tolerable the malaria vaccine called PfSPZ Vaccine is for healthy adults. Eligibility: Healthy adults: ages 18-35 in Ou(SqrRoot)(Copyright)less(SqrRoot)(Copyright)bougou, Mali not infected with HIV, Hepatitis B, or Hepatitis C for females, not pregnant or breastfeeding and must use reliable birth control during the study Design: Participants will be screened with questions about malaria and will undergo blood, urine, and heart tests. Participants will be randomly assigned to 1 of 4 groups. They will get injections of either the PfSPZ vaccine or a salt-water placebo. They will not know which one they get. One vaccine group and one placebo group will get an injection 3 times over 4 weeks. They will be followed for 7 months for a total of 26 visits. The other two groups (vaccine group and placebo) will get an injection 3 times over 16 weeks. They will be followed for 11 months for a total of 34 visits. All participants will be treated with an antimalarial medication prior to the third injection. At vaccine visits, female participants will have a pregnancy test before injection. All participants will have an arm cleaned and the vaccine injected in a vein. They will be watched for 30 minutes. At non-vaccine visits, participants will have a physical exam and be asked how they are feeling. They will usually have blood tests.

Start: April 2018

P. Falciparum Infection Dynamics and Transmission to Inform Elimination

In the current study, three experimental approaches aiming at reducing malaria transmission will be tested. The study will cover two transmission season (2019 and 2020) and the interventions will vary by season. More specifically, in the 2019 transmission season (June-December) (Year 1), community case management of malaria (CCM) will be implemented in all eight villages as improved standard of care; in the 2020 transmission season (Year 2), the eight study villages will be divided into 4 study arms. CCM will continue in all villages; two villages will continue with CCM only (Arm 1, control); the three other pairs of villages will receive active fever screening and treatment (Arm 2); monthly mass screening and treatment (MSAT) (Arm 3); and mass drug administration (MDA) during the last 3 months of the dry season (April-June) (Arm 4). For MDA, the whole population (except for those not fulfilling the entry criteria) will be treated with a full course of dihydroartemisinin-piperaquine (DP) (320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet) per manufacturer's guidelines (once daily for 3 days and according to body weight). The MDA treatment will be repeated 3 times at monthly intervals.

Start: August 2019

Malaria Birth Cohort

Aim od the study is the investigation of immunity development against malaria with regards to parasite, human, and socio-economic factors. In detail, the objectives are as follows: Analysis of temporal changes of immune cell phenotypes, their correlation with protection and pathology Analysis of temporal changes of humoral immune responses, their correlation with protection and pathology, and analysis of protective antibody responses over time Analysis of malaria specific autoantibody profiles at time of birth (T=0) compared to after completion of first year of life and their association with disease outcome Analysis of parasite diversity during different malaria episodes in the first year of life Analysis of the influence of malaria infection on human endothelial activation Analysis of development, composition, diversity, and richness of intestinal microbiota from birth to 12 months and its relationship to occurrence and severity of malaria Analysis of behavioural, socio-economic and environmental factors and pathways associated with malaria in children The study is planned as a prospective birth cohort. Pregnant women will be recruited in the study hospital during antenatal care visits over a period of twelve months to account for seasonal fluctuations in disease prevalence. Children will be passively followed for 12 months at regular vaccination visits in the frame of the EPI schedule (WHO Expanded Program of Immunization), which are organised by the health facilities in the district according to a fixed schedule. The participant's household will be visited within the first six weeks after birth to conduct questionnaires and record residential GPS coordinates. An additional visit is scheduled for 12 months after birth for a last follow-up visit. Parents and primary caregivers are encouraged to bring their child to the study hospital in case of a fever episode for an examination and treatment.

Start: April 2019

Efficacy of Two Dual Active Ingredient Long Lasting Insecticidal Nets for Control of Malaria Transmitted by Pyrethroid Resistant Vectors in Benin

The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides have been developed to control resistant mosquitoes. The efficacy of two bi-treated LLIN are compared to a standard LLIN in a three-arm, single blinded, cluster-randomized trial in Cove, Benin. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ The control arm: Interceptor, a standard LLIN treated with alpha-cypermethrin. The primary outcome of the trial will be malaria case incidence in children aged 6 months to 10 years.

Start: January 2020