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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607634582899 Date of Registration: 28/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Phase I, first-in-human study to assess safety, tolerability, and immunogenicity of the Rift Valley Fever virus Vaccine DDvax in healthy adult participants
Official scientific title A Phase I, first-in-human, single center, double-blind, randomized, placebo-controlled, dose escalation study to assess safety, tolerability, and immunogenicity of the Rift Valley Fever virus Vaccine DDvax in healthy adult participants
Brief summary describing the background and objectives of the trial Although a number of vaccines for either human or livestock use have been developed since Rift Valley Fever virus (RVFV) was first isolated in 1931 in Kenya, these vaccine products were associated with various issues, including reproductive toxicity associated with abortions, requirement for multiple booster injections after the initial immunization, and/or manufacturing difficulties. Due to these drawbacks, their use has been limited, and there are no commercially available and fully United States Food and Drug Administration or European Medicines Agency approved human vaccines to date. Considering the explosive nature of Rift Valley Fever (RVF) outbreaks affecting general populations with significant morbidity and mortality, combined with broad negative economic impacts from livestock production losses, there is an urgent medical need for developing safe and effective vaccines. To meet this critical health need and overcome previous limitations of other live-attenuated and inactivated vaccines, the live-attenuated vaccine candidate DDvax™, was developed. Primary Objective • To assess the safety and tolerability of different doses of RVFV candidate vaccine DDvax administered intramuscularly in RVFV seronegative healthy adults Secondary Objective • To assess the vaccine induced-specific antibody levels and functionality following immunization with DDvax vaccine in RVFV seronegative healthy adults. • To determine the optimal dose of DDvax in RVFV-seronegative healthy adults for further clinical development. Exploratory Objective • To further characterize the vaccine-induced innate and T cell immunology contributing to immune responses after vaccination with DDvax in RVFV seronegative healthy adults
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Rift Valley Fever
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 09/11/2026
Actual trial start date
Anticipated date of last follow up 09/03/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
Recruitment status Not yet 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 DDvax 2.16 × 10 power 3 PFU Single dose Active Group 1 21
Control Group Placebo 0.5mL Single dose Placebo 4 Placebo
Experimental Group DDvax 2.16 × 10 power 4 PFU Single dose Active Group 2 21
Control Group Placebo 0.5mL Single dose Placebo 4 Placebo
Experimental Group DDvax 2.16 × 10 power 5 PFU Single dose Active Group 3 21
Control Group Placebo 0.5mL Single dose Placebo 4 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male or female aged 18 to 45 years 2. Signed an Informed Consent Form 3. Correctly answered all questions on the protocol and study procedures on the “understanding the study” questionnaire within 2 attempts 4. Able and willing to comply with the protocol schedule and procedures 5. Agreement to release medical and other information concerning contra-indications for participation in the study, and to be attended by a study investigator for physical examination and any other clinical investigations. 6. No known ongoing, symptomatic acute or chronic illness requiring medical or surgical care 7. Female participants must not be pregnant or nursing and must have a negative pregnancy test at screening. Women of childbearing potential must use an acceptable contraceptive method for at least 30 days before and through 180 days after vaccination. Acceptable methods include hormonal contraceptives (eg, injectable, implant, patch, ring) or an intrauterine device (IUD). Barrier methods alone are not considered sufficient 8. Male participants must use an acceptable method of contraception (eg, condom with spermicide or condom with diaphragm) or another approved contraception method, for at least 3 months after vaccination. 9. Agrees not to donate blood for 6 months after vaccination. 10. Planned long-term (at least 12 months) or permanent residence in Bagamoyo district. 11. Has regular access to a working mobile phone for communication purposes. 12. Agrees to provide personal contact information and contact information of a third-party household member or close friend (in case clinic personnel cannot reach the participant) to the study team. 1. Serologic evidence of RVFV infection/prior vaccination with any RVF vaccine 2. Participation in another study involving receipt of an IP in the 30 days preceding randomization or receipt of a biologic within 90 days prior to randomization/planned use during the study period 3. History of allergic reaction to other vaccines/DDvax components or seizure disorder/encephalitic process or Guillain-Barre Syndrome 4. Frequent/moderate/severe headaches 5. Chronic/severe/recurrent joint pain/arthritis 6. Hemoglobin A1c >6.5% 7. Lab screening tests: o Absolute Neutrophil Count: <1.18 × 10 3/µl o Absolute Lymphocyte Count: <1.19 × 10 3/µl o Hemoglobin: <9.6 g/dL in females; <12.6 g/dL in males o Platelets: <107 × 10 3/µl o Creatinine: >95.3 µmol/L o ALT: >46.8 U/L (1.25 × ULN) o AST: >93.4 U/L (1.25 × ULN) o Total Bilirubin: >31.1 µmol/L 8. Any confirmed/suspected immunosuppressive/immunodeficient state 9. Current use of antiviral/systemic immunomodulatory pharmacotherapy 10.Chronic use of immunosuppressive agents/corticosteroids 11. Vaccination with any attenuated live-vaccine <60 days prior to Day 1, or planned vaccination within 60 days after DDvax administration 12. Vaccination with any inactivated vaccine ≤30 days prior to Day 1, or planned vaccination within 60 days after DDvax administration 13. Administration of immunoglobulins and/or any blood products within the 12 months preceding the planned administration of the vaccine candidate 14. Axillary temperature >37.8°C at the time just prior to vaccine administration 15. BMI >30 kg/m2 or <18 kg/m2 16. History of multiple sclerosis 17. Signs/symptoms/medical conditions indicating intercurrent/new illness during the screening period or at the time of planned vaccine administration 18. Known disturbance of coagulation 19. Screening tests positive for HIV/active Hepatitis B/C Virus 20. Drug/alcohol abuse in the previous 5 years 21. Previous diagnosis of any serious psychiatric disorder Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 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
No 10/07/2026 Ifakara Health Institute IRB
Ethics Committee Address
Street address City Postal code Country
Plot 463, Kiko Avenue Mikocheni P.O Box 78373 Dar Es Salaam 00000 United Republic of Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 10/07/2026 National Institute for Medical Research NIMR
Ethics Committee Address
Street address City Postal code Country
2448 Ocean Road P.O Box 9653 Dar Es Salaam 11101 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination (D0 to D7) First 7 days, Day 0 - Day 7 Post - intervention
Primary Outcome Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination (D0 to D7) First 7 days, Day 0 - Day 7 Post - intervention
Primary Outcome Occurrence of unsolicited adverse events (AEs) 28 days following vaccination (D0 to D28). First 28 days, Day 0 - Day 28 Post - intervention
Primary Outcome Change from baseline (D0) for safety laboratory measures (D2, D7, and D28) Day 2, Day 7 and Day 28 Post - intervention
Primary Outcome Summaries of vital signs and physical examination (D0 to D28) First 28 days, Day 0 - Day 28 Post - intervention
Primary Outcome Serious Adverse Events (SAEs), adverse events of special interest (AESIs), and Newly Diagnosed Chronic Medical Conditions (NDCMCs) (D0 to D28) First 28 days, Day 0 - Day 28 Post - intervention
Primary Outcome Occurrence SAEs, AESI, and NDCMCs post D28 until the end of the study Beyond 28 days, Day 29 - Day 356 Post - intervention
Primary Outcome Changes in clinical laboratory measurements at additional time points, summaries of vital signs, ECG, and physical examination results throughout the study period Beyond 28 days, Day 29 - Day 356 Post - intervention
Secondary Outcome RVFV-specific serological indicator as measured by ELISA following vaccination with DDvax vaccine D0, D14, D28, D84, D168, and D356 Post - intervention
Secondary Outcome Anti-RVFV neutralizing effect of DDvax-induced antibodies following vaccination with the DDvax vaccine (ie, increase in RVFV-specific neutralizing antibodies from baseline D0 to >limit of detection / quantification) D0, D14, D28, D84, D168, and D356 Post - intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ifakara Health Institute Bagamoyo Clinical Trial Facility P.O. Box 74 Bagamoyo 0000 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Coalition for Epidemic Preparedness Innovations CEPI Skoyen Atrium, Askekroken 11 Oslo 0258 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor One Health Institute University of California Davis One Shields Avenue California 95616 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Colorado State University Department of Microbiology Immunology and Pathology 1601 Campus Delivery Fort Collins 80523 United States of America
BioMARC Biopharmaceutical Manufacturing and Academic Resource Center Colorado State University Foothills Campus 3185 Rampart Road Fort Collins 80523 United States of America
University of Pittsburgh 300 MURDC 3420 Forbes Ave Pittsburgh 15260 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ally Olotu aolotu@ihi.or.tz 255718927104 Kingani Area P.O. Box 74
City Postal code Country Position/Affiliation
Bagamoyo 61301 United Republic of Tanzania Principal Investigator
Role Name Email Phone Street address
Public Enquiries Michelle Botha michelle.botha@iqvia.com 27126712200 1021 Lenchen Avenue North
City Postal code Country Position/Affiliation
Centurion 0157 South Africa Associate Director Global Site Activation
Role Name Email Phone Street address
Scientific Enquiries Brian Bird bhbird@ucdavis.edu +15307524859 1089 Vet. Med Drive VM3b Room 1020
City Postal code Country Position/Affiliation
Davis Carlifornia 95616 United States of America Chief Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymized individual participant data (IPD) and related study documents that underlie the results of this study (including analysis datasets and protocols) will be shared, subject to appropriate safeguards. Study Protocol Anonymized IPD may be made available beginning within 12 months after completion of the final study report or publication of primary results, whichever occurs first, and will remain available for up to 5 years. Access will be provided to qualified researchers following submission and approval of a research proposal and execution of a data sharing agreement. Data will be shared via a secure access mechanism. Participant confidentiality will be protected through data anonymization.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 21/05/2026 Delay expected in trial start date 07 Sep 2026 09 Nov 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 21/05/2026 Updated due to the delay in trial start date 07 Jan 2028 09 Mar 2028
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 12/06/2026 The RVF study is a dose-escalation design with three sentinel participants per group, and dosing groups will not be receiving the different doses at the same time. The intervention assignment options in the portal do not accurately reflect this design. As advised by PACTR Admin via email dated 21 Apr 2026, a single-group design was suggested to be the most appropriate, as it is the standard approach for dose escalation studies in Phase 1 clinical trials, where the groups receive different doses at different times. We have now updated it to “parallel” but would appreciate your further guidance. Single Group Parallel: different groups receive different interventions at same time during study
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/05/2026 Protocol Amendment Experimental Group, DDvax, 5.40 × 10 power 4 PFU, Single dose, Active Group 1, 21, Experimental Group, DDvax, 2.16 × 10 power 3 PFU, Single dose, Active Group 1, 21,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/05/2026 Protocol Amendment Experimental Group, DDvax, 1.08 × 10 power 5 PFU , Single dose, Active Group 2, 21, Experimental Group, DDvax, 2.16 × 10 power 4 PFU , Single dose, Active Group 2, 21,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 28 days Primary Outcome, Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days Day 0 - Day 7
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days Day 0 - Day 7 Primary Outcome, Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days, Day 0 - Day 7
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Primary Outcome, Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days, Day 0 - Day 7 Primary Outcome, Occurrence of solicited local reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days, Day 0 - Day 7 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 28 days Primary Outcome, Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days Day 0 - Day 7
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days Day 0 - Day 7 Primary Outcome, Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days, Day 0 - Day 7
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Primary Outcome, Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days, Day 0 - Day 7 Primary Outcome, Occurrence of solicited systemic reactogenicity signs and symptoms 7 days following vaccination (D0 to D7), First 7 days, Day 0 - Day 7 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Occurrence of unsolicited adverse events (AEs) 28 days following vaccination (D0 to D28)., First 28 days Primary Outcome, Occurrence of unsolicited adverse events (AEs) 28 days following vaccination (D0 to D28)., First 28 days Day 0 - Day 28
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Occurrence of unsolicited adverse events (AEs) 28 days following vaccination (D0 to D28)., First 28 days Day 0 - Day 28 Primary Outcome, Occurrence of unsolicited adverse events (AEs) 28 days following vaccination (D0 to D28)., First 28 days, Day 0 - Day 28
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Primary Outcome, Occurrence of unsolicited adverse events (AEs) 28 days following vaccination (D0 to D28)., First 28 days, Day 0 - Day 28 Primary Outcome, Occurrence of unsolicited adverse events (AEs) 28 days following vaccination (D0 to D28)., First 28 days, Day 0 - Day 28 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Change from baseline (D0) for safety laboratory measures (D2, D7, and D28), First 28 days Primary Outcome, Change from baseline (D0) for safety laboratory measures (D2, D7, and D28), Day 2, Day 7 and Day 28
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Primary Outcome, Change from baseline (D0) for safety laboratory measures (D2, D7, and D28), Day 2, Day 7 and Day 28 Primary Outcome, Change from baseline (D0) for safety laboratory measures (D2, D7, and D28), Day 2, Day 7 and Day 28 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Summaries of vital signs and physical examination (D0 to D28), First 28 days Primary Outcome, Summaries of vital signs and physical examination (D0 to D28), First 28 days, Day 0 - Day 28
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Primary Outcome, Summaries of vital signs and physical examination (D0 to D28), First 28 days, Day 0 - Day 28 Primary Outcome, Summaries of vital signs and physical examination (D0 to D28), First 28 days, Day 0 - Day 28 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Serious Adverse Events (SAEs), adverse events of special interest (AESIs), and Newly Diagnosed Chronic Medical Conditions (NDCMCs) (D0 to D28), First 28 days Primary Outcome, Serious Adverse Events (SAEs), adverse events of special interest (AESIs), and Newly Diagnosed Chronic Medical Conditions (NDCMCs) (D0 to D28), First 28 days, Day 0 - Day 28
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Primary Outcome, Serious Adverse Events (SAEs), adverse events of special interest (AESIs), and Newly Diagnosed Chronic Medical Conditions (NDCMCs) (D0 to D28), First 28 days, Day 0 - Day 28 Primary Outcome, Serious Adverse Events (SAEs), adverse events of special interest (AESIs), and Newly Diagnosed Chronic Medical Conditions (NDCMCs) (D0 to D28), First 28 days, Day 0 - Day 28 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Occurrence SAEs, AESI, and NDCMCs post D28 until the end of the study, Beyond 28 days Primary Outcome, Occurrence SAEs, AESI, and NDCMCs post D28 until the end of the study, Beyond 28 days, Day 29 - Day 356
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Primary Outcome, Occurrence SAEs, AESI, and NDCMCs post D28 until the end of the study, Beyond 28 days, Day 29 - Day 356 Primary Outcome, Occurrence SAEs, AESI, and NDCMCs post D28 until the end of the study, Beyond 28 days, Day 29 - Day 356 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/05/2026 Response to Reviewer Comment Primary Outcome, Changes in clinical laboratory measurements at additional time points, summaries of vital signs, ECG, and physical examination results throughout the study period, Beyond 28 days Primary Outcome, Changes in clinical laboratory measurements at additional time points, summaries of vital signs, ECG, and physical examination results throughout the study period, Beyond 28 days, Day 29 - Day 356
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Primary Outcome, Changes in clinical laboratory measurements at additional time points, summaries of vital signs, ECG, and physical examination results throughout the study period, Beyond 28 days, Day 29 - Day 356 Primary Outcome, Changes in clinical laboratory measurements at additional time points, summaries of vital signs, ECG, and physical examination results throughout the study period, Beyond 28 days, Day 29 - Day 356 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Secondary Outcome, RVFV-specific serological indicator as measured by ELISA following vaccination with DDvax vaccine, D0, D14, D28, D84, D168, and D356 Secondary Outcome, RVFV-specific serological indicator as measured by ELISA following vaccination with DDvax vaccine, D0, D14, D28, D84, D168, and D356 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 21/07/2026 Response to Reviewer Comment Secondary Outcome, Anti-RVFV neutralizing effect of DDvax-induced antibodies following vaccination with the DDvax vaccine (ie, increase in RVFV-specific neutralizing antibodies from baseline D0 to >limit of detection / quantification), D0, D14, D28, D84, D168, and D356 Secondary Outcome, Anti-RVFV neutralizing effect of DDvax-induced antibodies following vaccination with the DDvax vaccine (ie, increase in RVFV-specific neutralizing antibodies from baseline D0 to >limit of detection / quantification), D0, D14, D28, D84, D168, and D356 Post - intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/05/2026 Delay in submission is expected FALSE, Ifakara Health Institute IRB, Plot 463, Kiko Avenue Mikocheni P.O Box 78373, Dar Es Salaam, 00000, United Republic of Tanzania, 11 May 2026, , +255222774714, irb@ihi.or.tz, FALSE, Ifakara Health Institute IRB, Plot 463, Kiko Avenue Mikocheni P.O Box 78373, Dar Es Salaam, 00000, United Republic of Tanzania, 10 Jul 2026, , +255222774714, irb@ihi.or.tz,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/06/2026 Delay in submission is expected FALSE, Ifakara Health Institute IRB, Plot 463, Kiko Avenue Mikocheni P.O Box 78373, Dar Es Salaam, 00000, United Republic of Tanzania, 10 Jul 2026, , +255222774714, irb@ihi.or.tz, FALSE, Ifakara Health Institute IRB, Plot 463, Kiko Avenue Mikocheni P.O Box 78373, Dar Es Salaam, 00000, United Republic of Tanzania, 28 Jul 2026, , +255222774714, irb@ihi.or.tz,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/06/2026 Delay in submission is expected FALSE, Ifakara Health Institute IRB, Plot 463, Kiko Avenue Mikocheni P.O Box 78373, Dar Es Salaam, 00000, United Republic of Tanzania, 28 Jul 2026, , +255222774714, irb@ihi.or.tz, FALSE, Ifakara Health Institute IRB, Plot 463, Kiko Avenue Mikocheni P.O Box 78373, Dar Es Salaam, 00000, United Republic of Tanzania, 10 Jul 2026, , +255222774714, irb@ihi.or.tz,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 21/05/2026 Delay in submission is expected FALSE, National Institute for Medical Research NIMR, 2448 Ocean Road P.O Box 9653 , Dar Es Salaam, 11101, United Republic of Tanzania, 20 May 2026, , 25522212140, info@nimr.or.tz, FALSE, National Institute for Medical Research NIMR, 2448 Ocean Road P.O Box 9653 , Dar Es Salaam, 11101, United Republic of Tanzania, 10 Jul 2026, , 25522212140, info@nimr.or.tz,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/06/2026 Delay in submission is expected FALSE, National Institute for Medical Research NIMR, 2448 Ocean Road P.O Box 9653 , Dar Es Salaam, 11101, United Republic of Tanzania, 10 Jul 2026, , 25522212140, info@nimr.or.tz, FALSE, National Institute for Medical Research NIMR, 2448 Ocean Road P.O Box 9653 , Dar Es Salaam, 11101, United Republic of Tanzania, 28 Jul 2026, , 25522212140, info@nimr.or.tz,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/06/2026 Delay in submission is expected FALSE, National Institute for Medical Research NIMR, 2448 Ocean Road P.O Box 9653 , Dar Es Salaam, 11101, United Republic of Tanzania, 28 Jul 2026, , 25522212140, info@nimr.or.tz, FALSE, National Institute for Medical Research NIMR, 2448 Ocean Road P.O Box 9653 , Dar Es Salaam, 11101, United Republic of Tanzania, 10 Jul 2026, , 25522212140, info@nimr.or.tz,