Clinical Research Directory

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.

Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts

The MOVIE-TRACE project includes two complementary observational studies designed to improve the understanding of Mpox virus infection and its transmission within affected communities. The MOVIE study aims to describe the dynamics of viral clearance in patients with confirmed Mpox. It measures how the viral load changes over time in different biological samples to inform decisions about patient management and isolation guidelines. The TRACE study focuses on understanding how mpox spreads from confirmed cases to their contacts. It will estimate the Secondary Attack Rate (SAR) and identify factors associated with transmission risk. The results will help guide public health strategies for contact tracing, vaccination, and outbreak control.

Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)

This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of the LC16m8 mpox vaccine in individuals aged one year and older in the DRC. This study aims to assess the LC16m8 vaccine effectiveness and safety. The following activities will be carried out: * Community engagement * Enhanced health facility-based mpox disease surveillance * Vaccination using the LC16m8 vaccine * Safety monitoring following immunization * LC16m8 Vaccine effectiveness evaluation using a TND Study Hypothesis: The LC16m8 vaccine, administered as pre-exposure prophylaxis, confers greater than 70% protection against symptomatic mpox disease among adults and children in the DRC.

Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC

This Phase 3 double-blinded, randomized study aims to evaluate the safety and immunogenicity of the two-dose MVA-BN mpox vaccine regimen, administered subcutaneously, in infants and children aged 4 to 24 months in the Democratic Republic of the Congo (DRC), a population at high risk of mpox infection and complications. The study will compare the safety and immunogenicity of a full-dose regimen versus a half-dose regimen in this population. A hierarchical testing strategy will be applied as follows: first, non-inferiority of the full-dose regimen in infants/children (4-24 months old) will be evaluated against the full-dose regimen in adults from the POX-MVA-045 study. If non-inferiority is demonstrated, the immunogenicity of the half dose in infants/children (4-24 months old) will subsequently be tested for non-inferiority vs the full dose in adult. The trial will be conducted in Boende, Tshuapa Province, DRC. The trial plans to enroll 344 male and female infants/children, who will be randomized to receive two doses of the MVA-BN vaccine administered 28 days apart. Participants in Child Group 1 (N=172) will receive the standard vaccine dose (0.5 mL), while those in Child Group 2 (N=172) will receive half the standard dose (0.25 mL), with both groups following the same dosing schedule. This study builds on positive safety and immunogenicity data from prior trials that support the use of the standard dose regimen in younger children. However, considering the developmental differences in the immune systems of infants and young children/adolescents, it aims to evaluate whether a half-dose regimen can provide similar immunogenicity while potentially reducing reactogenicity. The findings will offer valuable insights into the optimal dosing strategy for this age group, balancing safety and immunogenicity to inform future vaccination recommendations.

An Immunogenicity and Safety Trial of MVA-BN in Adults Living With HIV for the Prevention of Mpox Infection, in Kinshasa, DRC

This is an open-label, phase 2, immunogenicity and safety trial of the MVA-BN vaccine for the prevention of mpox in adults living with HIV with different level of CD4 counts in Kinshasa, DRC. The study team aims to investigate whether the administration of 2 standard subcutaneous doses of the Modified Vaccinia Ankara of Bavarian Nordic (MVA-BN) vaccine given 28 days apart, is immunogenic and safe when administered to People Living with HIV (PLHIV) with different levels of CD4 counts in the Democratic Republic of the Congo (DRC). Enrollment will be stratified according to three different subgroups based on CD4 counts assessed during visit 1A: \<200 cells/µL; 200 to 499 cells/µL; ≥ 500 cells/µL. A total of 600 participants will be included in the trial, with 200 participants per subgroup. All participants will be invited to 6 trial visits over a period of 7 months. This study will take place in cooperation with the National Programme for the Fight against AIDS (PNLS), the 'Programme Elargi de Vaccination (PEV)' and the 'Institut National de Santé Publique (INSP)'. As part of the response to the current mpox epidemic in DRC, a large cohort of about 10,000 individuals living in Kinshasa will be vaccinated in this program. Vaccination will take place in the Centre Hospitalier Kabinda (CHK) and the Pakadjuma Health Centre. All people living with HIV (PLHIV) with the intention to be vaccinated in the CHK, will be asked for their willingness to participate in the MBOTE-HIVAX clinical trial until the sample size of 600 participants needed for this clinical trial is reached.

Epidemiological and Clinical Characteristics of Mpox Outbreak in Equateur, the DR Congo (Part1)

The goal of this observational study is to characterize the clinical features of the 2024 mpox outbreak in Equateur Province of DRC and to identify associated risk factors. The main question it aims to answer is: * What are the clinical features of the 2024 mpox outbreak in Equateur Province of DRC? * What are the associated risk factors of the 2024 mpox outbreak? Participants which has mpox like symptoms will answer mpox investigations related questions and be collected skin lesions and whole blood samples.

Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the Democratic Republic of Congo (Part3)

The goal of this study is to evaluate the effectiveness of smallpox vaccination administered before the global eradication of smallpox against currently circulating mpox in the Democratic Republic of the Congo. The main question it aims to answer is: Is the smallpox vaccine experience protective against mpox infection ? Researchers will compare mpox test positive group and negative group to see if the smallpox vaccine can protect against mpox infection. Participants will * be included after informed consent, * respond the survey with structured questionnaire * and accept skin lesion and blood sampling.

DiagRaMIE Mpox Virus-RDC for the Diagnostic of Monkeypox

Monkeypox, caused by a virus in the Orthopoxvirus genus, is a zoonotic disease first identified in 1970 in the Democratic Republic of Congo (DRC). This infection, primarily present in Central and West Africa, has an incubation period of 6 to 21 days and initially presents with fever, headaches, muscle pain, and swollen lymph nodes. This is followed by a skin rash that evolves over 2 to 3 weeks. Lesions can spread from the face to the hands, feet, and mucous membranes, with a centrifugal distribution pattern. Diagnosis is performed using PCR, based on samples taken from lesions or cutaneous exudates, although oropharyngeal swabs may be required if skin lesions are absent. Since May 2022, a resurgence of cases has been observed in North America, Europe, and Africa, including the DRC. As of March 2024, 94,270 cases and 178 deaths have been reported. Although less lethal than smallpox, with a mortality rate of 1% to 10% depending on the region, monkeypox remains a health threat, especially for young children and immunocompromised individuals. In response, the Commissariat à l'Énergie Atomique (CEA) and NG Biotech have developed the NG-TestⓇ Monkeypox virus rapid diagnostic test to facilitate detection. This antigenic immunochromatographic test, based on clinical samples, offers an alternative to PCR, providing rapid results without the need for costly equipment or specialized expertise. Its validation is underway for CE marking, enabling a swift response to potential health crises. Preclinical trials have confirmed that this test detects the Mpox virus with a detection limit of 1.10⁴ pfu/mL and shows no cross-reaction with other common organisms. This clinical performance study aims to determine the effectiveness of this device using prospectively collected clinical samples. The study seeks to validate this rapid diagnostic test (RDT) and support its CE marking. Thus, this test could serve as an alternative to conventional PCR diagnostics, which require several hours to process and necessitate costly specialized equipment and expertise.

Mpox Biology, Outcome, Transmission and Epidemiology

The MBOTE-Kamituga clinical and virological characterization protocol is a prospective observational cohort study with clinical and virological description of suspected mpox cases and longitudinal follow-up of confirmed mpox cases. Research activities will be aligned as far as possible with the response to the epidemic.

Looking for Asymptomatic Mpox in a Population at High Risk

Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature.