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.: PACTR202412708603314 Date of Approval: 10/12/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Phase 2 Open-Label Study to Assess Safety and Immunogenicity of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Adults in an Outbreak Setting
Official scientific title A Phase 2, Rapid Response, Open-Label Study to Assess Safety and Immunogenicity of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Adults in an Outbreak Setting
Brief summary describing the background and objectives of the trial Currently there are no approved vaccines or therapeutics to treat individuals infected with MARV. Vaccines with durable protective immunity would be desirable for populations in areas of the world where outbreaks occur sporadically. The primary goal of the cAd3- Marburg vaccine development program is to create a safe and efficacious vaccine that can induce rapid immunity followed by durable protection against MVD. Previous studies have evaluated the safety and immunogenicity of the cAd3-Marburg vaccine in a small group of healthy adults up to 50 years of age in the United States (US) (NCT04723602). A Phase 2 study is ongoing in Kenya and Uganda to evaluate the safety, tolerability, and immunogenicity of the cAd3-Marburg vaccine in healthy adults up to 70 years of age (NCT05817422). This Phase 2 Rapid Response study will evaluate safety and immunogenicity of the cAd3- Marburg vaccine in adults aged ≥18 years in an outbreak setting in Rwanda. The purpose of this study is to describe the safety and immune response of cAd3-Marburg vaccine during the early stages of a Marburg outbreak in Rwanda. Blood samples obtained from vaccinated individuals will be aliquoted for immunogenicity testing which may provide additional supportive evidence for immuno-bridging to non-clinical data to infer protection of vaccinated humans. These data may be used in conjunction with non-clinical data to support licensure.
Type of trial Non-Randomised
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 Marburgvirus
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 03/10/2024
Actual trial start date 06/10/2024
Anticipated date of last follow up 31/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1700
Actual target sample size (number of participants)
Recruitment status 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
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group cAd3 Marburg vaccine 1.0 × 10 (11) PU dose at Day is one vaccine. 1 vaccine administered by study personnel via intramuscular injection into the participant's deltoid muscle, preferably to their non dominant arm. Once at Day 1 cAd3 Marburg vaccine 1700
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male and non-pregnant female participants ≥18 years who are able and willing to complete and provide written informed consent prior to any study procedure. 2. Is capable of understanding and agrees to comply with planned study procedures and to be available for all clinic follow-up for all planned study visits. 3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 4. Has a means to be contacted and to contact the investigator during the study. 5. Agree not to receive any vaccine within 28 days from study vaccination (prior and after) 6. Agree not to donate bone marrow, blood, or blood products until 3 months after the study vaccination. 7. In good general health without clinically significant medical conditions, based on medical history, physical examination, vital signs, and clinical laboratory results as deemed acceptable by the principal investigator. Female participant specific criteria: 1. Negative pregnancy serum test at screening, and negative urine pregnancy test before vaccination, if of reproductive potential. 2. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through 24 weeks after study vaccination if assessed to be woman of childbearing potential UNLESS they fulfill one of the following criteria: o At least 1 year postmenopausal. o Surgically sterile. Male participants must agree: 1. Not to father a child or donate sperm through study end. 2. To use a barrier (condom) means of birth control from vaccination through study end, if assessed to be of reproductive potential. 1. Pregnant or lactating female or plans to become pregnant or breastfeed 2. Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. 3. Known prior exposure to MARV or prior diagnosis of MVD, determined from the participant’s reported medical history. However, prior receipt of Ebola or Marburg investigational vaccine are non-exclusionary but will only need to be documented. 4. History of or active status of any of the following clinically significant conditions (not full list):  Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.  Allergic reaction to excipients in the IP including gentamycin, neomycin or streptomycin or any other aminoglycoside. 5. Has a clinically significant acute illness (this does not include minor illnesses) or temperature ≥38.0°Celsius (≥100.4°Fahrenheit) within 24 hours of the planned dose of IP. 6. Receipt of any of the following substances: Any investigational product in the past 28 days, use of immunomodulators or systemic glucocorticoids, receipt of blood products. Currently enrolled or planned to be enrolled in another study. 7. Current anti-tuberculosis prophylaxis or therapy. 8. Abnormality or permanent body art (such as tattoo) in deltoid region that would interfere with ability to observe or assess injection site reactions. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 03/10/2024 Republic of Rwanda National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
KN 3 RD, Kicukiro, Kigali 0000 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Count and percentage of vaccinated participants who develop:  SAEs,  solicited AEs,  unsolicited AEs,  AESI,  MAAE,  AE at each intensity level. up to Day 90
Secondary Outcome Quantitate antibody titers evolution from Day 1 to Day 29 post-vaccination Day 1- Day 29 post vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rwanda Biomedical Center KG 644 Street, Kimihurura Kigali Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
CEPI 1901 Pennsylvania avenue, NW, Suite 1003 Washington DC 20006 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rwanda Biomedical Center KG 644 St, Kigali, Kimihurura Kigali Rwanda Government
COLLABORATORS
Name Street address City Postal code Country
Sabin Vaccine Institute Inc 2000 Pennsylvania Avenue, NW, Suite Washington DC 20006 United States of America
CONTACT PEOPLE
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 South Africa Manager Global Site Activation
Role Name Email Phone Street address
Principal Investigator Hassan Sbomana hassan.sibomana@rbc.gov.rw +250788484811 KG 17 Ave,
City Postal code Country Position/Affiliation
Kigali Rwanda Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Vincent Mutabazi mutabazivincent@gmail.com +250788410827 KG 646 St, Kimihurura
City Postal code Country Position/Affiliation
Kigali Rwanda Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Proposal should be directed to mutabazivincent@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website
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 Official scientific title 19/12/2024 Title updated to include 'rapid response' A Phase 2 Open-Label Study to Assess Safety and Immunogenicity of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Adults in an Outbreak Setting A Phase 2, Rapid Response, Open-Label Study to Assess Safety and Immunogenicity of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Adults in an Outbreak Setting
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 03/12/2024 Entered every criteria in a separate line. 1. Pregnant or lactating female or plans to become pregnant or breastfeed 2. Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. 3. Known prior exposure to MARV or prior diagnosis of MVD, determined from the participant’s reported medical history. However, prior receipt of Ebola or Marburg investigational vaccine are non-exclusionary but will only need to be documented. 4. History of or active status of any of the following clinically significant conditions (not full list):  Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.  Allergic reaction to excipients in the IP including gentamycin, neomycin or streptomycin or any other aminoglycoside. 5. Has a clinically significant acute illness (this does not include minor illnesses) or temperature ≥38.0°Celsius (≥100.4°Fahrenheit) within 24 hours of the planned dose of IP. 6. Receipt of any of the following substances: Any investigational product in the past 28 days, use of immunomodulators or systemic glucocorticoids, receipt of blood products. Currently enrolled or planned to be enrolled in another study. 7. Current anti-tuberculosis prophylaxis or therapy. 8. Abnormality or permanent body art (such as tattoo) in deltoid region that would interfere with ability to observe or assess injection site reactions. 1. Pregnant or lactating female or plans to become pregnant or breastfeed 2. Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. 3. Known prior exposure to MARV or prior diagnosis of MVD, determined from the participant’s reported medical history. However, prior receipt of Ebola or Marburg investigational vaccine are non-exclusionary but will only need to be documented. 4. History of or active status of any of the following clinically significant conditions (not full list):  Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.  Allergic reaction to excipients in the IP including gentamycin, neomycin or streptomycin or any other aminoglycoside. 5. Has a clinically significant acute illness (this does not include minor illnesses) or temperature ≥38.0°Celsius (≥100.4°Fahrenheit) within 24 hours of the planned dose of IP. 6. Receipt of any of the following substances: Any investigational product in the past 28 days, use of immunomodulators or systemic glucocorticoids, receipt of blood products. Currently enrolled or planned to be enrolled in another study. 7. Current anti-tuberculosis prophylaxis or therapy. 8. Abnormality or permanent body art (such as tattoo) in deltoid region that would interfere with ability to observe or assess injection site reactions.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 03/12/2024 Clarified intervention description Experimental Group, cAd3 Marburg vaccine , 1.0 × 10 (11) PU dose at Day 1, Once at Day 1, cAd3 Marburg vaccine , 1700, Experimental Group, cAd3 Marburg vaccine , 1.0 × 10 (11) PU dose at Day is one vaccine. 1 vaccine administered by study personnel via intramuscular injection into the participant's deltoid muscle, preferably to their non dominant arm., Once at Day 1, cAd3 Marburg vaccine , 1700,
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 19/12/2024 Protocol does not have a maximum enrolment age 64 Year(s) 100 Year(s)