Kenema

Researchers are conducting a Phase 3, double-blinded, placebo-controlled, multicenter trial to assess whether azithromycin taken as a preventive treatment can reduce death rates in adults with advanced HIV disease. Participants eligible for the study must have confirmed HIV infection with low CD4 counts or specific treatment histories, reflecting advanced immunosuppression. The trial aims to better understand mortality outcomes related to this preventive approach in this population. Participants will be randomly assigned to receive either azithromycin tablets or placebo tablets for 28 days. All participants will be followed for 24 weeks after randomization to measure the main outcome of death from any cause, with total follow-up lasting 48 weeks. The study compares the effects of azithromycin prophylaxis against an inactive placebo to evaluate its impact on survival. During the study, participants will be monitored regularly to track health outcomes, particularly mortality. They must be able to start or adjust antiretroviral therapy within four weeks of joining the trial. Researchers will closely observe for any adverse effects, treatment adherence, and overall health status throughout the follow-up period to assess the safety and effectiveness of the intervention.

Researchers are evaluating the immune response to the recombinant Vesicular Stomatitis Virus delta-Glycoprotein Zaire Ebola Virus (rVSVDG-ZEBOV-GP) vaccine, also known as ERVEBO, among Ebola Virus Disease (EVD) survivors compared to people without prior Ebola exposure. This open-label, case-control study focuses on understanding how EVD survivors' immune systems respond to the vaccine, addressing concerns about waning immunity and possible recurrent infections. The vaccine has already been approved by the US Food and Drug Administration and used successfully in West African countries. The study will enroll 40 participants, split evenly between EVD survivors and matched controls with no prior Ebola infection. All participants will receive a single dose of the ERVEBO vaccine. After a two-week screening period, participants will be followed for six months. The study team will monitor and compare the immune response and occurrence of any adverse events after vaccination between the two groups. Participants will be asked to provide informed consent and undergo multiple blood collections over six months to measure antibody levels and vaccine safety. The primary outcomes include assessing the immune response durability and recording any side effects. The study is conducted at Kenema Government Hospital in Sierra Leone, in collaboration with Tulane University and supported by Merck & Co., with participants being adults aged 18 to 100 years who are not pregnant or lactating.