Kinshasa

Researchers are evaluating the safety, reactogenicity, and immune response of an mRNA-based vaccine candidate called BNT166a designed to protect against Mpox (Monkeypox), Smallpox, and Orthopoxvirus infections. This randomized, double-blind, placebo-controlled Phase II trial includes healthy adults who are either new to Orthopoxvirus exposure or have previous exposure through vaccination or infection. The study aims to understand the effects after one and two doses of the vaccine or placebo. Participants are divided into two groups: Cohort 1 includes adults aged 18 to 45 who have no prior Orthopoxvirus exposure, and Cohort 2 includes adults aged 18 to 64 with prior Orthopoxvirus exposure. All participants receive two intramuscular injections of either BNT166a or placebo, administered in the deltoid muscle of the non-dominant arm, spaced at least 28 days apart. The study duration for each participant is approximately 14 months. During the study, researchers will monitor participants for local and systemic reactions such as pain, redness, fever, headache, and muscle aches within seven days after each dose. They will also track the use of medications for symptom relief, any unsolicited adverse events, serious adverse events, medically attended events, and events leading to withdrawal. Safety and immune responses will be assessed throughout the trial and at its conclusion, providing a comprehensive view of the vaccine's effects over time.

Researchers are evaluating the immunogenicity and safety of the Modified Vaccinia Ankara of Bavarian Nordic (MVA-BN) vaccine for preventing mpox (monkeypox) in adults living with HIV in Kinshasa, Democratic Republic of the Congo. This phase 2, open-label trial includes 600 participants divided into three groups based on their CD4 cell counts: less than 200 cells/µL, 200 to 499 cells/µL, and 500 or more cells/µL. The study aims to assess whether two standard subcutaneous doses of the MVA-BN vaccine, given 28 days apart, produce a protective immune response and are safe in these subgroups. All participants will receive the MVA-BN vaccine on day 0 followed by a second dose on day 28. The vaccination is administered subcutaneously, and the trial is conducted in cooperation with national health programs in Kinshasa, including the Centre Hospitalier Kabinda and Pakadjuma Health Centre. This trial ties into the larger vaccination effort targeting approximately 10,000 individuals living in Kinshasa as part of the response to the current mpox epidemic. Participants will attend six study visits over seven months to monitor their health and immune response. Researchers will measure seroconversion rates for monkeypox virus neutralizing antibodies two weeks after the last vaccine dose. The study will also evaluate safety by monitoring adverse events and treatment adherence. The trial focuses on adults aged 18 to 45 years living with HIV who are receiving antiretroviral therapy and willing to comply with study procedures including contraception use for women of childbearing potential.

Researchers are evaluating the effects of treating asymptomatic bacteriuria (bacterial infection without symptoms) in pregnant individuals to potentially reduce the occurrence of small vulnerable newborns (SVN) and stillbirths (SB). This phase 3 randomized controlled trial is conducted in low- and middle-income countries as part of a global effort to improve newborn and child health, aligning with the World Health Organization's goal to end preventable deaths of newborns and children under five years old. The study involves about 1,134 pregnant participants across seven international sites working with partners from the United States. Participants are randomly assigned to receive either a 7-day course of oral nitrofurantoin monohydrate/macrocrystals (100 mg taken twice daily for 14 doses) or a matching placebo with the same schedule. This treatment phase occurs during pregnancy between 12 and 20 weeks of gestation. The study compares these two groups to assess the potential benefits of antibiotic treatment for asymptomatic bacteriuria in pregnancy. During the study, participants are closely monitored from pregnancy until 42 days after giving birth. Researchers collect data on the number of small vulnerable newborns and stillbirths, along with other health outcomes. The study also tracks adherence to the medication and assesses safety throughout the follow-up period. The total participation time covers screening, treatment, and postpartum monitoring to evaluate the impact of the interventions on both mothers and newborns.

Researchers are studying febrile illnesses in the Democratic Republic of Congo (DRC) to better understand their clinical features, causes, and outcomes. This research builds on a previous study called FIKI² and aims to evaluate new tools such as the CRP biomarker, the WHO AWARE antibiotic book, and electronic decision support systems to improve antibiotic use for community-acquired fever. The study also seeks to strengthen research capacity and maintain biobanks in the DRC while monitoring infectious causes like arboviruses. The study is a prospective observational cohort involving adults and children who visit emergency or outpatient clinics with fever. It includes clinical assessment, laboratory tests like malaria smears, CRP, hemoglobin, and white blood cell counts, and blood sample storage for further research. Depending on resources, the study may expand to additional sites and include detailed biomarker and pathogen analyses. It integrates the use of new tools to guide antibiotic use and track fever-related infections over time. Participants are followed for three weeks after enrollment, with assessments at the start and follow-up visits on days 7, 14, and 21. Researchers collect clinical data, laboratory results, and biobank samples. They evaluate antibiotic use, adherence, reasons for non-adherence, illness severity, hospital admissions, secondary visits, and overall outcomes. The study aims to provide important insights to improve fever management and surveillance in low-resource settings like the DRC.

Researchers are studying the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella (iNTS) disease in children under 5 years old living in the Kisantu Health Zone, Democratic Republic of Congo. This observational study uses a case-control design to compare malaria vaccination status between children with and without iNTS infection, aiming to understand if the malaria vaccine offers protection against iNTS. The study builds on existing fever surveillance at healthcare facilities where children presenting with fever are tested for malaria and iNTS infections. The malaria vaccine being evaluated is the R21/Matrix-M vaccine, introduced into the Expanded Program on Immunizations by the DRC Ministry of Public Health on October 29, 2024. Eligible children aged 6 to 24 months receive four doses: the first dose between 6 and 11 months, followed by a second dose one month later, a third dose one month after the second, and a booster dose seven months after the third. Laboratory diagnosis for iNTS uses automated blood culture, while malaria diagnosis is confirmed by blood smear microscopy and rapid diagnostic tests. PCR testing is used to confirm malaria parasitemia and species in iNTS-confirmed cases. Participants with positive blood cultures for iNTS or confirmed malaria receive treatment according to national guidelines, and hospitalized children are followed until discharge or death. Those discharged after enrollment are monitored every 7 to 9 days for up to 21 days to assess symptom improvement and disease outcomes. The main outcome measured is blood culture-confirmed iNTS disease, including malaria co-infections, comparing vaccinated and unvaccinated participants at the time of enrollment.

Researchers are investigating how monkeypox (mpox) spreads, affects different populations, and how well vaccines protect against it in the Democratic Republic of Congo (DRC). The study uses a cross-sectional survey design, collecting data from patients diagnosed with mpox at one point in time. It also includes a case-control approach comparing those who test positive for mpox to those who test negative to identify risk factors and assess vaccine effectiveness. The study is conducted in collaboration with international partners and focuses on provinces heavily affected by mpox outbreaks.

Researchers are conducting a large multi-country project to estimate the prevalence of high-risk human papillomavirus (HPV) infections among girls and women aged 9 to 50 years in South Asia and sub-Saharan Africa. The study also aims to understand the incidence of persistent HPV infection over two years among sexually active young women. Alongside these surveys, qualitative studies will explore how gender norms and stigma affect HPV risk and access to prevention and treatment services. The study uses two main approaches: cross-sectional surveys (CSS) and longitudinal studies (LS). The CSS will enroll girls and women aged 9-50 from urban and rural areas, collecting urine samples for HPV testing and gathering data on demographics, sexual history, and HPV awareness. The LS will follow sexually active girls and women aged 15-35 for up to 24 months, testing for persistent HPV infection every six months using self-collected vaginal swabs and urine samples. In some countries, blood samples may also be collected. Qualitative sub-studies involving interviews and focus groups will be conducted in selected countries to better understand risk factors and barriers. Participants will provide samples and complete questionnaires on demographics, sexual and reproductive history, HPV vaccination, and screening. The study will measure HPV prevalence at a single time point and the incidence of infections lasting six months or longer. Safety and ethical considerations include informed consent for adults or assent with guardian consent for minors. The study is planned to run from late 2023 through 2026, with ongoing data collection and analysis across multiple countries and populations.

Researchers are collecting detailed information about children with cancer who are treated at pediatric oncology units in French-speaking Africa. This registry aims to provide accurate data on the number of cases, disease stage, treatments, and outcomes to help improve pediatric cancer care and support local and national health planning. The project focuses on children and adolescents under 18 years old diagnosed with any type of cancer. The data includes demographic and socioeconomic details along with clinical status and treatment results. Information on vital status, treatment abandonment, and loss to follow-up is also gathered. Data is entered locally into an online system called REDCap and securely stored by the IT department at Gustave ROUSSY in Paris-Villejuif. Participants are children under 18 who come to participating hospitals for cancer treatment. Researchers track the number of children suspected of having cancer, their health status, treatment progress, and survival over any 12-month period. This ongoing registry helps monitor outcomes and supports efforts to improve pediatric oncology services in the region.

Researchers are analyzing data from a tertiary referral hospital in the Democratic Republic of Congo to determine whether patients with hypertensive heart disease have multiple other health conditions. The study focuses on understanding the management and outcomes of these patients in a low-resource setting. This cross-sectional study aims to provide insights into the burden of additional diseases alongside hypertensive heart disease. Data collection involves gathering individual patient information such as body mass index (BMI), cholesterol levels (HDL and LDL), kidney function markers like serum creatinine and urea, as well as the presence of conditions like dyslipidemia, stroke, and diabetes. These measurements will help describe the patients' overall health status and comorbidities. Participants will be adults diagnosed with hypertensive heart disease who are 18 years or older. The study evaluates blood pressure levels one month after enrollment as the primary outcome. Researchers will monitor and report on the management strategies used and the health results for these patients. There is no intervention or treatment administered as part of this observational study.

Arboviral diseases transmitted by Aedes mosquitoes, such as yellow fever, dengue, chikungunya, and Zika, are a growing public health concern worldwide, especially in Africa where data is limited. In Kinshasa, Democratic Republic of the Congo, these viruses have been detected in patients and mosquito transmission rates exceed World Health Organization standards. This study aims to implement and evaluate different strategies to control Aedes mosquitoes at various life stages in the city of Kinshasa to better understand and reduce disease risks. The study is a before-and-after interventional pilot conducted in four health areas of Mont Ngafula 1, Kinshasa, involving 400 households per intervention arm over 12 months. Four groups are studied: one with community-based environmental management alone; one combining environmental management with larvicidal control using pyriproxifen-based autodissemination stations; one combining environmental management with adult mosquito control using BG-GAT mass trapping; and a control group without interventions. These methods target the mosquito at different life stages to assess impact on vector density. Participants will undergo entomological surveys before, during, and after the interventions to measure mosquito density, with mosquitoes tested for arbovirus RNA. A serological survey of 450 people will assess exposure to Aedes-borne diseases. Questionnaires will gather community knowledge, attitudes, and practices about mosquito control before and after interventions. This comprehensive approach will evaluate the feasibility and effectiveness of the vector control strategies and improve understanding of disease exposure in the area.