Research Components

The Mpox prospective observational cohort study

Background

Nigeria, an endemic country for Mpox, has reported 3 times more cases of Mpox in the recent past (. Jan – July 2022) compared to the previous 2 years (i.e. 2020 – 2021). Recently as of Dec 2022, with 720 confirmed cases (471 male, 249 female) from 32 states and the FCT, majority being between 20-40 years (mobile group). Nigeria remains an epicenter in the West Africa region for Mpox2 and potentially beyond. The recent resurgence of Mpox in both endemic and non-endemic countries has emphasized critical gaps in the understanding of Mpox. Some experts have linked this recent resurgence to loss of herd immunity against smallpox as evident by the shift in the epidemiology3. Despite these postulations, the true burden of Mpox driving the recent epidemic is still unknown. The transmission dynamics is also unclear due to its current atypical presentation ranging from oral and genital lesions to systematic symptoms. These uncertainties are significant barriers towards developing evidence-based interventions. Developing the Mpox prospective observational cohort study (MPOCS) to assess the burden of Mpox and Mpox virus infection and transmission dynamics; leverage on this to assess trial readiness among this cohort would complement ongoing global efforts to bridge the research gaps towards Mpox outbreak preparedness.

Aim

The CAMP project aims to characterize and compare Mpox transmission dynamics in endemic and non-endemic regions. The aim of the Nigerian arm of CAMP is to conduct a prospective multi-country observational cohort study that will assess the burden of Mpox disease and Mpox virus infection as well as the transmission dynamics while assessing the feasibility for future early or late phase clinical trials for efficacy of Mpox therapeutic and vaccine candidates.

Primary Objectives

The primary objectives are classified based on the study cohort

Cohort 1:

Suspected (i.e. symptomatic) or confirmed Mpox cases

This includes individuals classified with acute febrile illness with skin lesions based on the case definition of suspects of Mpox or confirmed cases.

To characterize Mpox transmission dynamics among suspected and confirmed Mpox cases
Identify mechanisms of, and risk factors for human-to-human transmission.
To quantify the diagnostic yield of clinical specimens obtained from skin lesions
To assess the extent to which environmental surfaces/air in proximity to people with Mpox are contaminated with viral DNA and/or viable virus.
To determine serologic histories among suspected and confirmed Mpox cases To evaluate the molecular epidemiology of Mpox in Nigeria.
To characterize the serologic and cellular immune response to Mpox and identify immune correlates of protection.

Cohort 2:

Asymptomatic cases of Mpox (high-risk individuals SGM)

This includes individuals who are classified as high risk of Mpox. It includes sexual and gender minorities (SGM) including gay, sexual and transgender women) SGM.

To survey for asymptomatic infections and transmission of Mpox among high-risk populations – SGM
To estimate the seroprevalence, incidence and reversion of asymptomatic infection and prior subclinical infection among SGM - at high-risk group of Mpox in Nigeria.

Cohort 3:

Historical stored samples prior to recent Mpox outbreak

This involves the use of previously characterized stored samples.

To estimate the seroprevalence of asymptomatic infection among individuals whose samples are stored in Nigeria from other surveillance studies on emerging infections prior to the recent Mpox outbreak

The Animal Study

Background and rationale

Monkeypoxvirus (Mpox) is a zoonotic virus of the genus Orthopoxvirus family Poxviridae. It is known to be endemic in western and central Africa but limited surveillance and absence of specialized laboratories across these regions have hindered timescale monitoring. Since 2017, there has been an upsurge of human Mpox cases globally.

Several animals, including diverse Old and New World monkeys and apes as well as various rodents, have been reported to be susceptible to Mpox virus. It is crucial to investigate the role played by non-human primates and rodents in Mpox transmission and maintenance. Also, since companion animals like dogs can obtained Mpox from infected humans as recently reported, it is important to investigate the possibility of Mpox transmission among companion animals and how this can facilitate Mpox crossover to human and as well from humans to animal (reverse zoonosis).

Using an informed sampling method (result of research component I) to assess transmission of Mpox from positive participants to in-contact animals and as well determine Mpox prevalence in historical animal samples.

Aim

The aims of this component under the CAMP project are to investigate the role played by domesticated (companion and food animals) and wild animals in the maintenance and spread of Mpox virus to humans in Nigeria.

Objectives

To detect and characterize Mpox circulation among animals in contact with Mpox positive humans. A secondary objective is to demystify possible anthroponosis (reverse zoonosis) and zoonosis of Mpox virus in positive household by genetic and historical tracing
To investigate the presence of Mpox genome in historical samples from different domesticated and wild animals

SUMMARY OF THE COMMUNITY COMPONENT

The CAMP Project, dedicated to formative research on community willingness to accept vaccination for preventing human MPOX in Nigeria, has made significant strides during the reporting period, revealing crucial insights through a comprehensive mixed-methods approach. This cross-sectional study incorporated both qualitative and quantitative methods, utilizing Focus Group Discussions (FGDs), In-Depth Interviews (IDIs), and questionnaires to gather a holistic understanding of community perspectives on MPOX vaccination.

One of the key achievements of the project lies in its meticulous community engagement strategy. The project successfully navigated local contexts by conducting community entry activities, fostering collaboration with local authorities, and establishing relationship with communities in selected regions of Nigeria. This approach ensured the inclusion of diverse voices and perspectives in the research, enhancing the validity and applicability of the findings.

Through the qualitative arm of the study, the project delved into the community attitudes and beliefs regarding MPOX and vaccination. The 16 Focused Group Discussions (FGDs) and 64 In-depth Interview (IDI), conducted by trained research assistants, uncovered rich qualitative data on knowledge and awareness of the MPOX virus, perceptions of the vaccine, and factors influencing willingness to participate in a MPOX clinical trial. A total of 164 respondents participated in the Focused Group Discussions (FGDs) and 64 participants participated in the In-depth Interviews.

Quantitative data collection, facilitated through well-structured questionnaires, provided a quantitative dimension to the research. The project has achieved its target so far. Currently, reaching 524 community respondents across all the selected regions, in Bayelsa, Delta, Lagos, and Rivers. The questionnaire focused on key indicators such as knowledge and awareness of MPOX, willingness to accept the MPOX vaccine, and readiness to participate in a clinical trial. We achieved the targeted sample sizes for the quantitative and qualitative studies which enhances the project's statistical robustness.

In conclusion, the CAMP Project, through its innovative mixed-methods approach, robust community engagement, and commitment to ethical research practices, has generated valuable insights into community willingness to accept vaccination for human MPOX prevention in Nigeria. The outcomes of this research have the potential to influence public health interventions, policies, and community engagement strategies, contributing to the overall advancement of MPOX prevention efforts in the targeted regions.