Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202105682809727 Date of Approval: 24/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Snakebite Burden: Clinical Trial on COVIP-Plus Vaccine for Snakebite Management in Nigeria
Official scientific title COVIP-Plus AntiSnake Venom Vaccine Double-Blind Randomized Control Phase-1 Trial in Nigeria
Brief summary describing the background and objectives of the trial The World Health Organization has already recognized Snakebite burden as a Neglected Tropical Disease (NTD) and the morbidity and mortality from this condition mostly affect the poor rural farmers with an estimated yearly deaths of 32,000 in Sub-Saharan Africa. Nigeria carries a big chunk of this mortality hence the need for quick intervention. At present, there is no vaccine against Snakebite venom and the current antiSnake venom sera are expensive and their supply erratic. It has therefore become necessary to look for new strategies to curb the menace of this health problem. The proposed trial is a promising attempt to assess the safety, immunogenicity and efficacy of a plant-based recombinant subunit vaccine against antiSnake venom. A positive result from this study will make available a prevention strategy that can greatly reduce the burden of Snakebite in Nigeria and also SubSaharan Africa. The primary objectives of the trial are as follows: 1. To assess the safety profile and tolerability of the vaccine throughout the study period. 2. To assess vaccine efficacy and immunogenicity 3. To document the appropriate dosing and Schedule for the vaccine. The Secondary objectives of the trial are as follows: 1. To establish baseline levels of antibodies to common snake antivenin in normal volunteers of the study sample. 2. To compare the efficacy of COVIP-Plus induced Snake antiserum immunoglobulins with other Snake antisera (EchiTABG & SVA African-Lyophilized) on venoms of medically important Snakes in Nigeria. 3. To establish baseline databases on laboratory profiles and the effect of vaccine on the following: a. full blood count, b. Clotting time and Prothrombin time c. Serum electrolytes, d. Liver function e. Kidney function.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CPT
Disease(s) or condition(s) being studied Snakebite envenoming
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/06/2021
Actual trial start date
Anticipated date of last follow up 31/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group COVIP Plus vaccine 150mg/5ml injected intramuscularly and intraperitoneal Days 1 and 15 to all volunteers Monthly follow up of patients for 12 months 25
Control Group Placebo 5mls Days 1 and 15 to all volunteers 12 months follow up visit 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adults 18 years and above that volunteer for the study and grant consent will be recruited into the study 1. Pregnant women 2. Very old persons (>75 years). 3. Highly malnourished adults (BMI <18.5). 4. Those with a history or Family history of intolerance to Mucuna Pruriens seed. 5. Those detected to be suffering from renal and hepatic disease through the examination of the laboratory tests profile. 6. Those undergoing treatment for immunodeficiency and immunosuppressive disorders such as HIV/AIDS and Cancer. 7. Those on immunosuppressive medication such as steroids, radiotherapy and anticancer medications. 8. Women of childbearing age will be screened for pregnancy and will be counseled to avoid pregnancy in the first month of the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 Year(s) Both
All adult farmers 18 years and above that volunteer for the study and grant consent will be recruited into the study. 1. Pregnant women 2. Very old persons (>75 years). 3. Highly malnourished adults (BMI <18.5). 4. Those with a history or Family history of intolerance to Mucuna Pruriens seed and reactions to any component of the vaccine. 5. Those detected to be suffering from renal and hepatic disease through the examination of the laboratory tests profile. 6. Those undergoing treatment for immunodeficiency and immunosuppressive disorders such as HIV/AIDS and Cancer. 7. Those on immunosuppressive medication such as steroids, radiotherapy and anticancer medications. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/03/2020 National Health Research Ethics Committee of Nigeria
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health, Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja P.M.B. 083, Garki-Abuja Abuja 900240 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety profile of the vaccine 12 Months
Primary Outcome Efficacy and immunogenicity profile of the vaccine 12 Months
Primary Outcome Documentation of the appropriate dosing and schedule for the vaccine 12 Months
Secondary Outcome A profile of antibodies against common snakebites in the environment 30 days
Secondary Outcome The documentation of the comparative efficacy of COVIP-Plus induced sera against commonly commercial available sera 12 Months
Secondary Outcome Documentation of safety profile of COVIP-Plus vaccine on selected haematological and biochemical parameters in human 12 Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos University Teaching Hospital Comprehensive Health Centre Zamko, Langtang North Local Government Area of Plateau State Langtang Nigeria
Snakebite Treatment Hospital and Research Centre Snakebite Treatment Hospital and Research Centre, Kaltungo Kaltungo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Central Bank of Nigeria. Awaiting Grant Approval Plot 33, Abubakar Tafawa Balewa Way Central Business District, Cadastral Zone Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Africa Centre of Excellence in Phytomedicine Research and Development University of Jos No. 1, Road 4, University of Jos Senior Staff Quarters, Bauchi road Jos 930001 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
National Veterinary Research Institute P.M.B 01 Vom, Plateau State Nigeria. Jos Nigeria
Pan African Veterinary Vaccine Centre an African Union Debre Zeit, Ethiopia Debre Zeit Nigeria
University of Salford Maxwell Building, The Crescent, Salford M5 4WT, Salford United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aboi Madaki wankarani62@gmail.com +2348036249560 Department of Family Medicine, Jos University Teaching Hospital, Lamingo, Jos-North LGA
City Postal code Country Position/Affiliation
Jos Nigeria Professor and Clinical Trial Cordinator
Role Name Email Phone Street address
Public Enquiries Uchechukwu Ohaeri ohaeri.uchechukwu@yahoo.com +2348064920594 Africa Centre of Excellence in Phytomedicine Research and Development, No. 1, Road 4, University of Jos Senior Staff Quarters, Bauchi Road/Bauchi Ring-Road
City Postal code Country Position/Affiliation
Jos 930001 Nigeria Data Manager
Role Name Email Phone Street address
Scientific Enquiries John Aguiyi jca757@yahoo.com +2348037016418 Department of Pharmacology, Faculty of Pharmaceutical Sciences, University of Jos, Bauchi road
City Postal code Country Position/Affiliation
Jos 930001 Nigeria Vaccine Inventor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Africa Centre of Excellence in Phytomedicine Research and Development, (ACEPRD), University of Jos will make de-identified data of the study accessible to eligible scientist on request 12 months following the publication of the study. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months Data will be available to the public but will have controlled access and only established Researchers judged from their records of publications will be able to access data through a written request to the Africa Centre for Excellence in Phytomedicine Research and Development. The PI or Centre leader can grant access to de-identified data for secondary data analysis including such other studies as systematic review and meta-analysis. All request for access to data will be reviewed by the ACEPRD ethical Committee and only after approval has been granted that PI or Centre leader would grant access to the data to the approved researcher.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information