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.: PACTR202107612488277 Date of Registration: 15/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TANCoV trial
Official scientific title A Phase 1/2a, double-blinded Randomized Controlled Trial to assess Safety, Tolerability and Immunogenicity of TANCoV-1.3.20 SARS _CoV-2  vaccine in COVID-19 uninfected participants in Tanzania
Brief summary describing the background and objectives of the trial Many COVID-19 vaccine candidates, because of their thermolability, are required to be stored, distributed, handled, and delivered at ultralow temperatures of up to -70°C. These requirements pose logistical challenges that make it very difficult for community clinics and local pharmacies in developing countries to store and administer these vaccines to individuals who would want to be vaccinated against COVID-19. Furthermore, the cost of these vaccines is also very high, making them unfordable for poor people in most developing countries. The solutions are warranted for the above-mentioned challenges. TANCoV-1.3.20, the vaccine, which is being tested, is thermostable, which can be stored at ambient temperatures and administered through the nasal route while maintaining its stability. It is administered intranasally, and hence there is no need to use needles and syringes, therefore avoiding needle-stick injuries and disposal challenges as a large number of these items could be required during vaccination campaigns involving a large number of people. TANCoV-1.3.20 has been pre-clinically tested and found to be tolerable among white inbred mice, rabbits and pigs when experiments were done to determine the safety and immunogenicity of TANCoV-1 vaccine strain against COVID-19 infection. There was no adverse event observed during the entire period of the experiment in all the animals. On the other hand, the preclinical findings revealed that at 14 days and 28 days after vaccination, the titre was raised in all groups of animals vaccinated. But the group of animals that were not vaccinated (and hence served as a control), did not seroconvert throughout the study period of 28 days. Based on the preclinical results from animal models above, it was revealed that the TANCoV vaccine is safe and immunogenic thus suitable for clinical trials in humans. We are therefore proposing the first in a human clinical trial to evaluate safety and immunogenicity among healthy individuals
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TANCoV
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/03/2022
Actual trial start date 20/07/2022
Anticipated date of last follow up 19/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 169
Actual target sample size (number of participants) 169
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization 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
Control Group Group 1 6 months Sinopharm vaccine given intramuscularly and normal saline 100µL given nasally, and then at 28 days, a booster of Normal saline 100µL given nasally and Sinopharm vaccine given intramuscularly 30 Active-Treatment of Control Group
Experimental Group Group 2 6 months TANCoV vaccine 100 µL given nasally and normal saline given intramuscularly and booster at 28 days TANCoV vaccine 100µL given nasally and Normal saline given intramuscularly 28
Control Group Group 3 6 months Sinopharm vaccine given intramuscularly and normal saline 100µL given nasally and a booster at 28 days; Sinopharm vaccine given intramuscularly 28 Active-Treatment of Control Group
Experimental Group Group 4 6 months TANCoV vaccine 100 µL given nasally and normal saline given intramuscularly and a booster at 28 days; Normal saline given intramuscularly 28
Control Group Group 5 6 months Sinopharm vaccine given intramuscularly and normal saline 200µL given nasally and a booster at 28 days; Sinopharm vaccine given intramuscularly 27 Active-Treatment of Control Group
Experimental Group Group 6 6 months TaNCoV vaccine 200 µL given nasally and normal saline given intramuscularly 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Healthy individuals aged between 18 to 45 years • Willingly given written informed consent • Willing to undergo COVID-19 testing. • Satisfactory completion of an assessment of understanding prior to enrolment defined as 80% and above • Resident in Dar es Salaam or Mbeya, and willing to remain in the same region for the duration of the study • Assurance that adequate birth control measures are used • For women, have a negative urine pregnancy test • Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination, and laboratory detection • History of immunodeficiency, chronic illness requiring continuous or frequent medical intervention • HIV, Hepatitis B and/or C infection • Hives or recurrent hives and severe eczema • History of psychiatric, medical, and/or substance abuse problems during the past six months • History of grand mal epilepsy, or currently taking anti-epileptics • Received blood or blood products or immunoglobulins in the past three months • Receiving immunosuppressive therapy • Receiving experimental therapeutic agents at the moments or within a few months • Reception of any live, attenuated vaccine within 90 days of study entry • Previously received COVID-19 candidate vaccines like Janssen, Sputnik, Sinovac, Sinopharm, Pfizer, and Moderna. • History of severe local or general reaction to vaccination • Lactating mother • Unlikely to comply with protocol procedures as judged by the investigator(s). Adult: 18 Year(s)-44 Year(s) 18 Year(s) 45 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 09/11/2021 Medical Research Coordinating Committee through National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
National Institute for Medical Research, 3 Barack Obama Drive, 11101 Dar es salaam, Tanzania Dar es Salaam 255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety, which will be assessed by clinical and laboratory parameters. We will grade clinical, haematological, and biochemical tests. We will look at the frequency, severity, and duration of the side effects/adverse events. Grading of adverse events will be done as per DAIDS grading tables 2,4,6,8,12,16,20 and 24 weeks post-last vaccination
Primary Outcome Humoral and cellular Immunogenicity (IgG, IgM, and CD4/CD8) will be assessed by HI and ELISA tests and by ELISPOT. 2,4,6,8,12,16,20 and 24 weeks post-last vaccination
Secondary Outcome Build expertise and capability in evaluating TANCoV vaccine candidates in Tanzania End of the project
Secondary Outcome Perception, attitude, and knowledge towards the TANCoV vaccine trial within study participants and their social environment Month 6
Secondary Outcome Characteristics of antibodies produced by TANCoV vaccines Month 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mwananyama Regional Referral Hospital Mwananyamala Dar es Salaam United Republic of Tanzania
NIMR Mbeya Medical Research Centre Mbeya Zonal Referral Hospital Mbeya United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The government of Tanzania Government City, Mtumba, Afya Road Dodoma United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kilimanjaro Clinical Research Institute P.O.BOX 2236 Moshi Tanzania Kilimanjaro United Republic of Tanzania Research Institute
COLLABORATORS
Name Street address City Postal code Country
National Institute for Medical Research Mbeya Medical Research Centre Mbeya Zonal Referral Hospital Mbeya United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sayoki Mfinanga gsmfinanga@yahoo.com +255784755632 NIMR Muhimbili
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Chief Scientist and Director
Role Name Email Phone Street address
Public Enquiries Mbazi Senkoro senkorombazi@gmail.com +255755859313 NIMR Muhimbili
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Principal Research Scientist
Role Name Email Phone Street address
Scientific Enquiries Sayoki Mfinanga gsmfinanga@yahoo.com +255784755632 NIMR Muhimbili
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Chief Scientist and Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? Yes What data, in particular, will be shared? Individual participant data that underlie the results reported in this article, after identification (text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication. Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. The analysis should be for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our Institute data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).
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