Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells
NCT07199569
Animal Diseases, DNA Virus Infections
Ames, Iowa, United States
View Trial DetailsNCT Number: NCT06840860
This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it. The study is designed as a cross-sectional survey, meaning researchers will collect and analyze data from patients diagnosed with mpox at a single point in time. It will also use a case-control approach, comparing people who test positive for the virus to those who test negative, to identify risk factors and evaluate the effectiveness of the vaccine.
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Observational
Masina Mpox Treatment Center, Kinshasa, Masina, Democratic Republic of the Congo
This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it. The study is designed as a cross-sectional survey, meaning researchers will collect and analyze data from patients diagnosed with mpox at a single point in time. It will also use a case-control approach, comparing people who test positive for the virus to those who test negative, to identify risk factors and evaluate the effectiveness of the vaccine.
The study is being conducted by Institut National de Recherche Biomédicale (INRB) in collaboration with several international partners, including the Institute of Tropical Medicine (ITM) in Belgium, Johns Hopkins University, the University of Manitoba, Médecins Sans Frontières (MSF), and other leading research institutions. The study is funded by organizations such as the European & Developing Countries Clinical Trials Partnership (EDCTP3) and the Belgian Federal Government.
The study will be carried out in the DRC, focusing on provinces that have been hit hardest by mpox outbreaks, including North Kivu, South Kivu, Maniema, Kinshasa, and Equateur. Participants will be recruited from hospitals and health centers that provide mpox testing and care.
What Will Happen During the Study?
Key Study Goals
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
The frequency and distribution of clinical symptoms and disease severity in confirmed mpox cases. (Percentage of cases presenting each symptom (e.g., fever, rash, lymphadenopathy)
Time frame: 2 years
The distribution of age, gender, occupation, and other demographic characteristics of confirmed mpox cases. (Mean/median values for continuous variables (e.g., age in years) and proportions for categorical variables (e.g., gender distribution, occupation)
Time frame: 2 years
The percentage of cases reporting different exposure factors contributing to mpox transmission. ( Proportion of cases with specific exposure risks)
Time frame: 2 years
The relative contribution of different modes of transmission to the spread of mpox in the studied population. (Proportion of cases attributed to specific transmission routes)
Time frame: 2 years
This measure assesses the protective effect of prior vaccination against mpox by comparing vaccination coverage among PCR-confirmed cases versus unconfirmed suspected cases in a test-negative case-control study. The primary metric is the odds ratio (OR) of prior vaccination among cases versus controls, with vaccine efficacy (VE) calculated as VE = 1 - OR.
Time frame: 2 years
Comparison of the frequency and distribution of clinical symptoms and disease severity in confirmed mpox cases across different regions of the DRC.
Time frame: 2 years
Comparison of sociodemographic factors such as age, gender, occupation, and household composition among confirmed mpox cases in different regions.
Time frame: 2 years
Comparison of reported exposure factors (e.g., human contact, animal exposure) among mpox cases in different regions of the DRC.
Time frame: 2 years
Comparison of the distribution of transmission modes in different regions, identifying dominant transmission pathways.
Time frame: 2 years
The frequency of clinical symptoms will be compared between infections caused by Clade Ia and Clade Ib, based on genomic sequencing data.
Time frame: 2 years
The severity of mpox disease will be assessed and compared between Clade Ia and Clade Ib infections. Severity classification will follow standardized clinical definitions.
Time frame: 2 years
Transmission modes will be compared between cases of Clade Ia and Clade Ib to identify potential differences in transmission dynamics.
Time frame: 2 years
This measure evaluates predictors of severe disease, including underlying comorbidities, demographic risk factors, and exposure history. It analyzes hospitalization rates, complications, and case fatality rates among mpox-positive patients.
Time frame: 2 years
This measure determines the prevalence of co-infections (e.g., measles, varicella, bacterial infections) among confirmed mpox cases, using PCR testing for other viral pathogens.
Time frame: 2 years
This measure quantifies the proportion of confirmed mpox cases that develop complications or result in fatality. A multivariate analysis will be conducted to identify independent predictors of severe disease progression.
Contact information is provided by the study sponsor or research team.
Laurens Liesenborghs, MD, PhD
CONTACT
Sarah Houben, PhD
CONTACT
Institute of Tropical Medicine, Belgium
Other
Monkeypox Biology, Outcome, Transmission and Epidemiology (MBOTE) Study: Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
Acronym: MBOTE-EPIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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