Understanding the human, animal and environmental interface of monkeypox transmission in Nigeria
| ISRCTN | ISRCTN16578298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16578298 |
| Secondary identifying numbers | UKPHRST_NMOHS_1.0 |
- Submission date
- 03/04/2024
- Registration date
- 11/04/2024
- Last edited
- 17/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Mpox virus, previously known as Monkeypox, poses a significant global health threat since its re-emergence in Nigeria in 2017, with increasing cases annually. In 2022, a global outbreak coincided with Nigeria's largest outbreak yet. Despite improved surveillance, key knowledge gaps persist, including the effectiveness of historical smallpox vaccination and the virus's transmission dynamics. To address these, a collaborative effort involving Nigerian and international institutions was initiated before the 2022 outbreak. The project aims to enhance understanding of Mpox transmission pathways through a One Health Study and to fill clinical knowledge gaps with a separate Clinical Characterization Study. This research aims to bolster prevention, response, and control measures in Nigeria and similar endemic areas. It is comprised of two linked studies: the One Health Study (this study) which aims to increase understanding of the spread of mpox infection (i.e. human-to-human, animal-to-human, environment-to-human) in Nigeria, and the Clinical Characterisation Study which will address knowledge gaps in the clinical understanding of the virus and the natural history of infection. The Clinical Study is registered separately and further details can be accessed here (https://www.isrctn.com/ISRCTN13739887)
Who can participate?
The Mpox One Health Study focuses on the households and other close (including intimate) contacts of confirmed cases as these people would have been exposed to mpox infection. The One Health Study will recruit participants by approaching cases identified by the Clinical Study and asking their permission to contact their household and other close contacts.
What does the study involve?
For participants, the study has several elements: blood sampling to identify undiagnosed, mild or asymptomatic mpox infection, a questionnaire about their exposure to the case and other risk factors and, in the follow-up visit 28 days later, participation in an interview where they will be asked to share their experiences of having mpox in their household/community. Households will be asked to give their permission for the One Health Study animal team to set traps to capture wild rodents and other small mammals in the vicinity of their household, and for their pets to be sampled to see if they are or have been infected with mpox. Finally, households will be asked to give permission for hard surfaces in their home to be swabbed, to see if mpox virus can be identified, and if so, whether it is capable of transmitting infection.
What are the possible benefits and risks of participating?
Participants’ data are pseudonymized and treated as confidential and all records and data are maintained securely. There are no direct benefits for an individual participant of this study but we believe the information gained from participants will help improve national the response to mpox as well as contribute to increasing global knowledge about mpox and its effects on human health.
Where is the study run from?
The Mpox One Health Study is run jointly by the Nigeria Centre for Disease Control and Prevention (NCDC), National Veterinary Research Institute (NVRI), and the UK Public Health Rapid Support Team. The study is sponsored by the London School of Hygiene and Tropical Medicine, London, UK.
When is the study starting and how long is it expected to run for?
August 2022 to March 2026
Who is funding the study?
UK Government ODA, via UK Public Health Rapid Support Team
Who is the main contact?
Dr Chioma Achi (Mpox Study Coordinator, UK-PHRST), ritahalichi@yahoo.com, chioma.achi@biology.ox.ac.uk
Contact information
Public, Scientific
Study Coordinator
UKPHRST, London School of Hygiene and Tropical Medicine, Keppel Street
London
WC1E 7HT
United Kingdom
 ORCID ID |
0000-0002-8765-2081 |
|---|---|
| Phone | +44(0)2079272802 |
| chioma.achi@biology.ox.ac.uk |
Principal Investigator
Study co-Principal Investigator
UKPHRST, London School of Hygiene and Tropical Medicine, Keppel Street
London
WC1E 7HT
United Kingdom
| ORCID ID |
0000-0002-1541-6637 |
|---|---|
| Phone | +44 7570340066 |
| hilary.bower@lshtm.ac.uk |
Scientific
Study Co-Investigator
Nigeria Centre for Disease Control and Prevention, 801 Ebitu Ukiwe, Jabi
Abuja
900001
Nigeria
| ORCID ID |
0000-0003-2732-7794 |
|---|---|
| Phone | +234 8107328566 |
| david.olatunji@ncdc.gov.ng |
Principal Investigator
Study co-Principal Investigator
Nigeria Centre for Disease Control and Prevention
801 Ebitu Ukiwe, Jabi
Abuja
900211
Nigeria
| ORCID ID |
0000-0002-5950-1868 |
|---|---|
| Phone | +234 8035643363 |
| olubunmi.olopha@ncdc.gov.ng |
Study information
| Study design | Multicentre mixed-methods observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community, Home |
| Study type | Other |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet. |
| Scientific title | Nigeria Mpox One Health Study |
| Study acronym | NMOHS |
| Study objectives | The Mpox One Health Study is one of two linked studies that aim to address a number of questions about the natural history and transmission of mpox virus in Nigeria. The One Health study focuses on establishing epidemiological parameters and transmission factors among case-household and proximate animals in Nigeria. The linked study, entitled the Nigeria Mpox Clinical Characterization Study [registration no. ISRCTN13739887], focusses on the clinical, immunological and virological features of the disease in confirmed cases and will be the source of the confirmed cases for the One Health Study. The study hypothesizes that establishing key epidemiological parameters (such as incidence, range of severity, rate of secondary transmission and risk factors for infection) and the relative importance of different routes of transmission (including animal-to-human and human-to-human) in case households and among close contacts will assist public health decision-makers in Nigeria and elsewhere to improve prevention and response activities. The study will also gather information on past and present mpox infection in rodents, domesticated and ‘bush’ animals in the vicinity of case-households and the role of surface contamination in household transmission. |
| Ethics approval(s) |
1. Approved 06/09/2023, National Health Research Ethics Committee of Nigeria (NHREC) (Department of Health Planning, Research & Statistics, Federal Ministry of Health, 11th Floor, Federal Secretariat Complex Phase III, Ahmadu Bello Way, Abuja, 900211, Nigeria; +234-09-523-8367; secretary@nhrec.net), ref: NHREC/01/01/2007-06/09/2023 2. Approved 16/10/2023, London School of Hygiene and Tropical Medicine Observational /Interventions Research Ethics Committee (Keppel Street, London, WC!E 7HT, United Kingdom; +44 20 7636 8636; ethics@lshtm.ac.uk), ref: 28801 3. Approved 30/10/2023, Government of Rivers State of Nigeria Health Research Ethics Committee (Rivers State Hospitals Management Board, 26 Okoroma Street, Port Harcourt, PMB 6083, Nigeria; +234-084-230828; rshmbph@yahoo.com), ref: RSHMB/RSHREC/2023/052 4. Approved 31/07/2023, National Veterinary Research Institute (NVRI), Vom, Nigeria Animal Ethics Committee (Vom, Plateau State, Jos, P.M.B 01, Nigeria; +234 8111118533; edvr@nvri.gov.ng), ref: NVRI/AEC/03/136/2 5. Approved 18/03/2024, London School of Hygiene & Tropical Medicine Animal Welfare and Ethical Review Board (Keppel Street, London, WC1E 7HT, United Kingdom; +44 20 7636 8636; ethics@lshtm.ac.uk), ref: 2023-08 6. Approved 22/11/2023, Lagos State Government Social Approval (Block 4, The Secretariat, Alausa, Ikeja, P.M.B 210007, Nigeria; +234-1-4969061; joywenuga@lagosstate.gov.ng), ref: LSMH/4773/1/78 7. Submitted 18/03/2024, Government of Ogun State Health Research Ethics Committee (Ogun State Hospitals' Management Board) (BLOCK A, STATE SECECRETARIAT COMPEX, OKE-MOSAN, Abeokuta, P.M.B 2226, Nigeria; +234 803 681 0362; info@ogunhmb.com.ng), ref: - |
| Health condition(s) or problem(s) studied | Monkeypox |
| Intervention | Multicentre mixed-methods observational cohort study of case households and non-household contacts using paired serology, exposure data and perception interviews, and cross-sectional animal and environmental sampling Demographic and exposure data will be collected at recruitment and at follow-up visits, using a structured questionnaire. Blood samples will be taken at recruitment and follow-up visits, for serological analyses of anti-orthopox antibodies. Biological samples of wild rodents/small mammals and domestic animals will be collected for laboratory analysis to identify presence of the mpox virus and anti-orthopox antibodies. Pets will be sampled after appropriate non-harmful restraint including blood and oral, nasal, and skin scab swabs. Wild rodents and small mammals will be collected in traps placed near targeted households. They will be anesthetized prior to blood sampling and euthanized prior to tissue sampling. Environmental samples will be collected for laboratory analysis and where possible cultured to identify whether any virus found is infection-competent. There are no pharmaceutical interventions in this study. |
| Intervention type | Other |
| Primary outcome measure | 1. Household incidence and secondary transmission estimated by qPCR (cases) and orthopox serology (asymptomatic or un-diagnosed contacts) at baseline and day 28 following household enrolment, taking into account previous smallpox vaccination. 2. Symptomatic, pauci-symptomatic and asymptomatic fractions of mpox infection based on orthopox serology and symptom questionnaires, at baseline and day 28 following household enrolment. 3. Identification of key risk factors and drivers of human mpox infection using risk ratios derived from individual exposure questionnaires in cases, household members and non-household close contacts carried out at baseline and covering a period of 1 month prior to household enrolment, and at day 28 following household enrolment covering the period since enrolment in the study. 4. Evidence of active and past infection in animals in the vicinity of a case household identified using PCR and serology on blood, tissue and swab samples at the time point of sampling. 5. Evidence of extent of surface contamination in case households using qPCR on samples taken on day 1 and day 3 after household enrolment. Cultures will be done on the same samples if resources allow. |
| Secondary outcome measures | 1. Identification of barriers to and enablers for mpox prevention and control using themes derived from qualitative information gained using semi-structured household interviews on day 28 following household enrolment and covering the period since the household became aware of mpox. The period will vary depending on household experience. 2. Description of case household knowledge, experience and perceptions of mpox from qualitative information gained using semi-structured household interviews on day 28 following household enrolment and covering the period since the household became aware of mpox. The period will vary depending on household experience. 3. Identification of possible reservoirs of mpox virus using serology results by species derived from samples taken at one time point. |
| Overall study start date | 21/08/2022 |
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 200 (accepted range 150-250) households across 3 States: 900 – 1500 household participants including the index cases; 750 -1250 non-household contacts; approximately 200 rodents/small mammals and 225 domestic pets. |
| Key inclusion criteria | 1. Confirmed mpox cases and all their household members (defined as people living together within the same residential structure and sharing meals) and up to five non-household close contacts will be invited to take part regardless of age, sex, pregnancy, smallpox vaccine status, language, or any other variable. 2. Wild rodents/small mammals in and around the case household will be trapped for sampling (unless pregnant or lactating). Cats and dogs in the case household and neighbouring households will also be sampled. All animal trapping and sampling will be done with relevant household consent. |
| Key exclusion criteria | There are no exclusion criteria |
| Date of first enrolment | 05/02/2024 |
| Date of final enrolment | 30/01/2026 |
Locations
Countries of recruitment
- Nigeria
Study participating centres
Nigeria
Nigeria
Nigeria
Sponsor information
University/education
Keppel street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 2079272802 |
|---|---|
| uk-phrst@lshtm.ac.uk | |
| Website | http://www.lshtm.ac.uk/ |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Manuscripts describing study results will be submitted to peer-reviewed scientific journals for publication. Results will be shared with mpox stakeholders including participating States and communities, in Nigeria and elsewhere, and presented and scientific meetings and conferences. Results may also be shared via UKPHRST and NCDC websites and press releases, including plain language summaries |
| IPD sharing plan | The datasets generated during and/or analysed during the study will be stored in a non-publicly available repository maintained by NCDC. All individual participant stored data will be pseudonymised, so individuals cannot be identified by those accessing the data. Use of any stored data or residual biological samples by other researchers will be controlled by a data and materials access committee. The committee will have scientist members and advisers from Nigeria and the UK, and processes will be in place for making requests to access data or materials, and for reviewing and approving or rejecting requests. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 03/10/2023 | 09/04/2024 | No | No |
Additional files
Editorial Notes
17/02/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 04/02/2025 to 30/01/2026.
2. The overall study end date was changed from 31/03/2025 to 31/03/2026.
09/04/2024: Trial's existence confirmed by London School of Hygiene and Tropical Medicine
