Sudan Ebola Virus VaccinesPhase 1/2TOKOMEZANCT05909358
Solidarity/Tokomeza Ebola Trial
A Phase 1/2 study testing CAd3, ChAdox1 and rVSV-SUDV in people with Sudan Ebola Virus Vaccines, run by Makerere University.
Trial summary
The TokomezaPlus Ebola trial is a phase I/II double blind randomised clinical trial designed to assess the safety and immunogenicity of candidate SUDV vaccines in Uganda during the inter outbreak period. Uganda is prone to Ebola virus disease outbreaks especially those caused by the Ebola Sudan (SUDV) species. Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudan Ebola Virus Vaccines
- What is being tested?
- CAd3, ChAdox1 and rVSV-SUDV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,121 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Phase 1
- Healthy volunteers aged 18-50 years from study communities
- Healthy volunteers with a permanent home address
- Able and willing to complete and provide written informed consent. In case the participant cannot read or write, the procedures must be explained to him/her and informed consent must be witnessed by a literate third party not involved with the conduct of the study
- Participant must pass the informed consent test of understanding (TOU)
- Participant must be healthy in the investigator's clinical judgement on the basis of medical history, physical examination, vital signs and point of care tests (where applicable) performed at screening
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- If female of child-bearing potential and heterosexually active, practice of adequate contraception for 28 days prior to injection, negative pregnancy test on the day of vaccination, and agreement to continue adequate contraception until 90 days after vaccination
- Male participants are eligible to participate in the study if they agree to use a male condom during any heterosexual intercourse with a female of childbearing potential until 90 days after vaccination
- Phase 2
- Healthy volunteers aged 6 years-65 years from study communities. Individuals with comorbidities assessed as stable will be allowed to participate
- With a permanent home address
- Able and willing to complete and provide written informed consent or assent as applicable. In case the participant cannot read or write, the procedures must be explained to him/her, and informed consent must be witnessed by a literate third party not involved with the conduct of the study.
- Participant must pass the informed consent or assent test of understanding (TOU)
- Participant must be healthy according to the investigator's clinical judgement on the basis of medical history, physical examination, vital signs and point of care tests (where applicable) performed at screening
- If female of child-bearing potential and heterosexually active, practice of adequate contraception for 28 days prior to injection, negative pregnancy test on the day of vaccination, and agreement to continue adequate contraception until 180 days after vaccination
- Male participants are eligible to participate in the study if they agree to abstain from any heterosexual intercourse with a female of childbearing potential or must agree to use a male condom
Who cannot join
- Phase 1
- History of confirmed ebola virus diseases (SUDV, EBOV or BUDV)
- Unwillingness of female participants to use effective contraception
- Participation in an interventional clinical trial within 90 days of participation in this trial
- Prior vaccination with any Ebola vaccine
- Breastfeeding or planning to conceive within 2 months following study vaccination
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- Has history of fever (>100.4ºF/38.0ºC) within 48 hours prior to enrolment into the study
- Received systemic corticosteroids exceeding physiologic replacement doses (~5 mg/d prednisone equivalent) within 14 days prior to study entry
- Received any live virus vaccine within 30 days or any non-live virus vaccine within 14 days prior to study entry
- Has a known allergy/sensitivity or contraindication to investigational vaccines or its/their excipients?
- History of malignancy ≤5 years
- Major surgery within the 4 weeks prior to screening or planned major surgery through the course of the study (from screening until completion of the study)
- Presence of any condition that can interfere with the subject's participation for the full duration of the trial.
- HIV positive
- Hepatitis B positive
- Phase 2
- History of confirmed SUDV
- Unwillingness of female participants to use effective contraception
- Participation in an interventional clinical trial within 90 days of start of this trial
- Prior vaccination with any Ebola vaccine
- Breastfeeding or planning to conceive within 2 months following study vaccination
- Has history of fever (>100.4ºF/38.0ºC) within 48 hours prior to vaccination
- Received systemic corticosteroids exceeding physiologic replacement doses (~20 mg/d prednisone or equivalent) for 14 days within a month prior to study entry.
- Immunosuppressive medication within 3 months
- Received any live virus vaccine within 30 days or any non-live virus vaccine within 14 days prior to study entry
- Has a known allergy/sensitivity or contraindication to investigational vaccines or its/their excipients?
- History of malignancy ≤5 years
- Major surgery within the 4 weeks prior to screening or planned major surgery through the course of the study (from screening until completion of the study)
- Presence of any condition that can interfere with the subject's participation for the full duration of the trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II Randomized Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Sudan Ebolavirus Vaccines in Uganda
The TokomezaPlus Ebola trial is a phase I/II double blind randomised clinical trial designed to assess the safety and immunogenicity of candidate SUDV vaccines in Uganda during the inter outbreak period. Uganda is prone to Ebola virus disease outbreaks especially those caused by the Ebola Sudan (SUDV) species. TokomezaPlus Ebola Vaccine trial protocol has two main components: a) Safety b) Immunogenicity and is designed to create a living protocol that will be used to study the safety and immunogenicity of SUDV-candidate vaccines in the East African EVD-prone countries.
Read the detailed description
The Sudan ebolavirus and the Zaire ebolavirus are classified as different species, and vaccines and monoclonal antibodies that are effective against Zaire ebolavirus disease are unlikely to be of any use against SUVD. But, the epidemiology of SUVD is thought to be similar to that of Zaire ebolavirus disease.
There is an urgent need to test the safety and immunogenicity of the candidate vaccine(s) developed against Sudan ebolavirus. Once safety and immunogenicity (including extended immunogenicity) have been proven, these vaccines could be deployed for future outbreaks as part of the response.
OBJECTIVES Phase 1 Objectives
- To determine the safety of rVSV-SUDV candidate SUDV vaccine among healthy volunteers
- To determine the immunogenicity of rVSV-SUDV candidate SUDV vaccine
Phase 2 Primary objectives
- To determine the safety of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccine(s) among healthy volunteers and persons with stable comorbidities.
- To determine the immunogenicity of the three candidate SUDV vaccines.
Secondary objectives
- To determine the durability of SUDV-specific induced immune responses following vaccination with ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccine(s).
- To determine the factors associated with vaccine-induced immune responses.
- To determine the putative cross reactivity \& protection exerted by the SUDV vaccine candidates against other ebolaviruses (e. g. Bundibugyo ebolavirus (BUDV) and EBOV).
Exploratory objectives
- To determine the effect of SUDV vaccines on host gene expression
- To determine the T and B cell specific responses and immune profiling in response to vaccination
- To determine the effect of SUDV vaccines on the host metabolome
- To determine the effect of SUDV vaccines on host immune responses
END POINTS
Primary Endpoints
- Number of solicited, unsolicited adverse and serious adverse events that are determined as possibly, probably and definitely related to the investigational products.
- Binding antibody titres, neutralization activity and cell mediated immune responses.
Secondary Endpoints
- Durability of SUDV-specific induced immune responses following vaccination.
- Factors associated with vaccine-induced immune responses.
- To determine the putative cross reactivity \& protection exerted by the SUDV vaccine candidates against other ebolaviruses (e. g. Bundibugyo ebolavirus (BUDV) and EBOV).
TRIAL PARTICIPANTS This trial will enroll a total 250 healthy, adult volunteers (18-50 years) (150 intervention arm and 100 placebo arm) for the phase I rVSV-SUDV vaccine. The DSMB will review day 28 post vaccination safety data for all the phase I participants and day 56 post vaccination binding antibody IgG and IgM data for 50 participants randomly selected who receive the rVSV SUDV and 10 participants who receive the placebo to make a recommendation regarding proceeding to phase II. Participants enrolled in phase I of the rVSV-SUDV candidate vaccine will contribute data to phase II for this vaccine. For the Phase II trial (ChAdox1, CAd3 and rVSV-SUDV vaccines), 2121 volunteers aged 6 - 65 years will be included (606 for each of the vaccine arms and 303 to placebo). A randomly selected subset of120 participants per vaccine and 50 placebo recipients will participate in extended immunogenicity studies (long term immunogenicity and exploratory studies). 100 participants from each intervention arm participating in extended immunogenicity will randomly be selected to receive a homologous booster 12months post vaccination.
STATISTICAL ANALYSIS The primary analysis is the comparison of occurrence of solicited (within 7 days) and unsolicited adverse events (occurring within 56 days) considered possibly, probably or definitely related to vaccines as well as adverse and SAEs occurring within 24 months' post-vaccination between each candidate vaccine and placebo. AEs will be summarized with counts, percentages, and, when provided, exact 95% CIs will be provided. SAEs will be graded according to DAIDS. The primary analysis for the immunogenicity is the change in serum IgG and IgM titres from baseline to 56days post vaccination.
- Conditions
- Sudan Ebola Virus Vaccines
- Being tested
- CAd3, ChAdox1, rVSV-SUDV, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAd3Biological
CAd3 candidate vaccine which is one of the investigational products
ChAdox1Biological
ChAdox1 candidate vaccine which is one of the investigational products
rVSV-SUDVBiological
rVSV-SUDV candidate vaccine which is one of the investigational products
ControlOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Candidate vaccine 1 | Experimental | One injection of cAd3 will be administered to the study participants at enrollment. The participants will be monitored for 30 minutes after receipt of the vaccine and thereafter follow up done at different time points up to 72 months. Receives: Biological: CAd3 |
| Candidate vaccine 2 | Experimental | One injection of chAdOx1 will be administered to the study participants at enrollment. The participants will be monitored for 30 minutes after receipt of the vaccine and thereafter follow up done at different time points up to 72 months. Receives: Biological: ChAdox1 |
| Candidate vaccine 3 | Experimental | One injection of rVSV-SUDV will be administered to the study participants at enrollment. The participants will be monitored for 30 minutes after receipt of the vaccine and thereafter follow up done at different time points up to 72 months. Receives: Biological: rVSV-SUDV |
| Control | Placebo comparator | One injection of placebo will be administered to the study participants at enrollment. The participants will be monitored for 30 minutes after receipt of the vaccine and thereafter follow up done at different time points up to 72 months. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited, unsolicited adverse and serious adverse events (safety)
The adverse events (AE) and serious adverse events (SAE) will be evaluated to determine the link to the investigational product. They will then be classified as possibly, probably and definitely related to the investigational products
Measured: 72 months
Vaccine-specific antibody concentration (immunogenicity) measured as optical density that will be converted to concentration
The vaccine specific antibody concentration will be assessed through specific laboratory procedures that make use of Nunc Maxisorp flat bottom plates will be coated with Ebola GP in a coating buffer. Heat inactivated serum or plasma from study participants (either diluted and or undiluted) or treated plasma sample from SUDV convalescent individuals (Positive control) or Mouse anti SUDV GP mAb (positive control) will be added to the plates and incubated. The plates will be washed and HRP goat anti-human IgG antibody and or HRP goat anti-human IgM antibody and or HRP goat anti-mouse IgG Fc or HRP goat anti-mouse IgM Fc will be added. The plates will be washed and tetramethylbenzidine (TMB) 1 component microwell peroxidase substrate added. The reaction will be stopped after about 20 minutes with hydrochloric acid. The plate's absorbance will be read at 450 nm and 630 nm. A standard curve/line will be drawn and convert the optical density to concentration
Measured: 72 months
Vaccine specific antibody neutralization capability (immunogenicity) represented as proportion of neutralization
Vero cells will be incubated in Eagles Minimum Essential Medium with fetal bovine serum and penicillin/streptomycin (R10) and maintained at 37°C and 5% CO2 humidified incubator. The cells will be plated onto a 96 well black flat bottomed culture plate.
Study participant, positive (obtained from SUDV convalescent individuals and pre-treated) and negative controls heat inactivated serum samples will be diluted and mixed with single round infecting recombinant vesicular stomatitis virus expressing SUDV GP and firefly luciferase at room temperature with appropriate controls. The virus and serum sample mixture will be added to the plated vero cells and incubated for up to 24 hours. The virus and serum sample will be removed and vero cells lysed. Luciferase activating reagent will be added and the luminescence will be read using a luminescence plate reader. The proportion of neutralisation will be evaluated using appropriate controls (rVSV without serum).
Measured: 72 months
Vaccine-induced T cell responses (immunogenicity) determined as spot forming units per one million cells.
This will be done as per the standard operating procedures. IFN-γ precoated ELISPOT plates will be washed and blocked using serum. Thawed and rested PBMC will be plated, stimuli (peptides to ebola GP, appropriate positive and negative controls) added and incubated for 12 to 24 hours.
The plates will be emptied and washed after incubation. Diluted enzyme-conjugate detection IFN-γ antibody will be added and incubated. The plates will be washed \& substrate added and allowed to develop for about 20 minutes. The development will be stopped by rinsing the plates in copious amounts of deionised water. The plates will be allowed to air dry in the dark and read using an ELISPOT reader within 12 hours.
The results will be determined as spot forming units per one million cells
Measured: 72 months
Secondary outcomes (1)
Durability of the immune response measured up to 72 months quantitively by assessing the antibody concentration and qualitatively by assessing the antibody neutralization capacity. Curves will be drawn to represent immune responses against time
Blood samples will be collected at different time points and the immunogenicity assays repeated. Curves will then be drawn to represent how the antibody titers against time
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudan Ebola Virus VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase I/II double blind randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University Lung Institute, MRC/UVRI and LSHTM Uganda Research Unit, Makerere University Walter Reed Program, Epicentre, Uganda Virus Research Institute-International Aids Vaccine Initiative, Ministry of Health, Uganda
- Responsible party
- Principal investigator, Bruce J Kirenga, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909358
- Sponsor's protocol ID
- TOKOMEZA PLUS
- Acronym
- TOKOMEZA
- Status last verified
- Jun 2023
- First submitted
- 30 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon reasonable request. The request will be discussed within the trial consortium
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Sudan Ebolavirus Vaccines in Uganda
- ClinicalTrials.gov ID
- NCT05909358
- Acronym / sponsor ID
- TOKOMEZA / TOKOMEZA PLUS
- Conditions
- Sudan Ebola Virus Vaccines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,121 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Makerere University Lung Institute, MRC/UVRI and LSHTM Uganda Research Unit, Makerere University Walter Reed Program, Epicentre, Uganda Virus Research Institute-International Aids Vaccine Initiative, Ministry of Health, Uganda
- Study start
- Jul 2023 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TokomezaPlus Ebola trial is a phase I/II double blind randomised clinical trial designed to assess the safety and immunogenicity of candidate SUDV vaccines in Uganda during the inter outbreak period. Uganda is prone to Ebola virus disease outbreaks especially those caused by the Ebola Sudan (SUDV) species. TokomezaPlus Ebola Vaccine trial protocol has two main components: a) Safety b) Immunogenicity and is designed to create a living protocol that will be used to study the safety and immunogenicity of SUDV-candidate vaccines in the East African EVD-prone countries.
Detailed description
The Sudan ebolavirus and the Zaire ebolavirus are classified as different species, and vaccines and monoclonal antibodies that are effective against Zaire ebolavirus disease are unlikely to be of any use against SUVD. But, the epidemiology of SUVD is thought to be similar to that of Zaire ebolavirus disease.
There is an urgent need to test the safety and immunogenicity of the candidate vaccine(s) developed against Sudan ebolavirus. Once safety and immunogenicity (including extended immunogenicity) have been proven, these vaccines could be deployed for future outbreaks as part of the response.
OBJECTIVES Phase 1 Objectives
- To determine the safety of rVSV-SUDV candidate SUDV vaccine among healthy volunteers
- To determine the immunogenicity of rVSV-SUDV candidate SUDV vaccine
Phase 2 Primary objectives
- To determine the safety of ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccine(s) among healthy volunteers and persons with stable comorbidities.
- To determine the immunogenicity of the three candidate SUDV vaccines.
Secondary objectives
- To determine the durability of SUDV-specific induced immune responses following vaccination with ChAdox1, CAd3 and rVSV-SUDV candidate SUDV vaccine(s).
- To determine the factors associated with vaccine-induced immune responses.
- To determine the putative cross reactivity \& protection exerted by the SUDV vaccine candidates against other ebolaviruses (e. g. Bundibugyo ebolavirus (BUDV) and EBOV).
Exploratory objectives
- To determine the effect of SUDV vaccines on host gene expression
- To determine the T and B cell specific responses and immune profiling in response to vaccination
- To determine the effect of SUDV vaccines on the host metabolome
- To determine the effect of SUDV vaccines on host immune responses
END POINTS
Primary Endpoints
- Number of solicited, unsolicited adverse and serious adverse events that are determined as possibly, probably and definitely related to the investigational products.
- Binding antibody titres, neutralization activity and cell mediated immune responses.
Secondary Endpoints
- Durability of SUDV-specific induced immune responses following vaccination.
- Factors associated with vaccine-induced immune responses.
- To determine the putative cross reactivity \& protection exerted by the SUDV vaccine candidates against other ebolaviruses (e. g. Bundibugyo ebolavirus (BUDV) and EBOV).
TRIAL PARTICIPANTS This trial will enroll a total 250 healthy, adult volunteers (18-50 years) (150 intervention arm and 100 placebo arm) for the phase I rVSV-SUDV vaccine. The DSMB will review day 28 post vaccination safety data for all the phase I participants and day 56 post vaccination binding antibody IgG and IgM data for 50 participants randomly selected who receive the rVSV SUDV and 10 participants who receive the placebo to make a recommendation regarding proceeding to phase II. Participants enrolled in phase I of the rVSV-SUDV candidate vaccine will contribute data to phase II for this vaccine. For the Phase II trial (ChAdox1, CAd3 and rVSV-SUDV vaccines), 2121 volunteers aged 6 - 65 years will be included (606 for each of the vaccine arms and 303 to placebo). A randomly selected subset of120 participants per vaccine and 50 placebo recipients will participate in extended immunogenicity studies (long term immunogenicity and exploratory studies). 100 participants from each intervention arm participating in extended immunogenicity will randomly be selected to receive a homologous booster 12months post vaccination.
STATISTICAL ANALYSIS The primary analysis is the comparison of occurrence of solicited (within 7 days) and unsolicited adverse events (occurring within 56 days) considered possibly, probably or definitely related to vaccines as well as adverse and SAEs occurring within 24 months' post-vaccination between each candidate vaccine and placebo. AEs will be summarized with counts, percentages, and, when provided, exact 95% CIs will be provided. SAEs will be graded according to DAIDS. The primary analysis for the immunogenicity is the change in serum IgG and IgM titres from baseline to 56days post vaccination.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- A phase I/II double blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Candidate vaccine 1 | Experimental | Biological: CAd3One injection of cAd3 will be administered to the study participants at enrollment. The participants will be monitored for 30 minutes after receipt of the vaccine and thereafter follow up done at different time points up to 72 months. |
| Candidate vaccine 2 | Experimental | Biological: ChAdox1One injection of chAdOx1 will be administered to the study participants at enrollment. The participants will be monitored for 30 minutes after receipt of the vaccine and thereafter follow up done at different time points up to 72 months. |
| Candidate vaccine 3 | Experimental | Biological: rVSV-SUDVOne injection of rVSV-SUDV will be administered to the study participants at enrollment. The participants will be monitored for 30 minutes after receipt of the vaccine and thereafter follow up done at different time points up to 72 months. |
| Control | Placebo comparator | Other: ControlOne injection of placebo will be administered to the study participants at enrollment. The participants will be monitored for 30 minutes after receipt of the vaccine and thereafter follow up done at different time points up to 72 months. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Phase 1
- Healthy volunteers aged 18-50 years from study communities
- Healthy volunteers with a permanent home address
- Able and willing to complete and provide written informed consent. In case the participant cannot read or write, the procedures must be explained to him/her and informed consent must be witnessed by a literate third party not involved with the conduct of the study
- Participant must pass the informed consent test of understanding (TOU)
Key exclusion criteria (29 listed)
- Phase 1
- History of confirmed ebola virus diseases (SUDV, EBOV or BUDV)
- Unwillingness of female participants to use effective contraception
- Participation in an interventional clinical trial within 90 days of participation in this trial
- Prior vaccination with any Ebola vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAd3CAd3 candidate vaccine which is one of the investigational products | Biological | Candidate vaccine 1 |
| ChAdox1ChAdox1 candidate vaccine which is one of the investigational products | Biological | Candidate vaccine 2 |
| rVSV-SUDVrVSV-SUDV candidate vaccine which is one of the investigational products | Biological | Candidate vaccine 3 |
| ControlPlacebo | Other | Control |
Primary outcome
Incidence of solicited, unsolicited adverse and serious adverse events (safety)
Time frame: 72 months
The adverse events (AE) and serious adverse events (SAE) will be evaluated to determine the link to the investigational product. They will then be classified as possibly, probably and definitely related to the investigational products
Vaccine-specific antibody concentration (immunogenicity) measured as optical density that will be converted to concentration
Time frame: 72 months
The vaccine specific antibody concentration will be assessed through specific laboratory procedures that make use of Nunc Maxisorp flat bottom plates will be coated with Ebola GP in a coating buffer. Heat inactivated serum or plasma from study participants (either diluted and or undiluted) or treated plasma sample from SUDV convalescent individuals (Positive control) or Mouse anti SUDV GP mAb (positive control) will be added to the plates and incubated. The plates will be washed and HRP goat anti-human IgG antibody and or HRP goat anti-human IgM antibody and or HRP goat anti-mouse IgG Fc or HRP goat anti-mouse IgM Fc will be added. The plates will be washed and tetramethylbenzidine (TMB) 1 component microwell peroxidase substrate added. The reaction will be stopped after about 20 minutes with hydrochloric acid. The plate's absorbance will be read at 450 nm and 630 nm. A standard curve/line will be drawn and convert the optical density to concentration
Vaccine specific antibody neutralization capability (immunogenicity) represented as proportion of neutralization
Time frame: 72 months
Vero cells will be incubated in Eagles Minimum Essential Medium with fetal bovine serum and penicillin/streptomycin (R10) and maintained at 37°C and 5% CO2 humidified incubator. The cells will be plated onto a 96 well black flat bottomed culture plate. Study participant, positive (obtained from SUDV convalescent individuals and pre-treated) and negative controls heat inactivated serum samples will be diluted and mixed with single round infecting recombinant vesicular stomatitis virus expressing SUDV GP and firefly luciferase at room temperature with appropriate controls. The virus and serum sample mixture will be added to the plated vero cells and incubated for up to 24 hours. The virus and serum sample will be removed and vero cells lysed. Luciferase activating reagent will be added and the luminescence will be read using a luminescence plate reader. The proportion of neutralisation will be evaluated using appropriate controls (rVSV without serum).
Vaccine-induced T cell responses (immunogenicity) determined as spot forming units per one million cells.
Time frame: 72 months
This will be done as per the standard operating procedures. IFN-γ precoated ELISPOT plates will be washed and blocked using serum. Thawed and rested PBMC will be plated, stimuli (peptides to ebola GP, appropriate positive and negative controls) added and incubated for 12 to 24 hours. The plates will be emptied and washed after incubation. Diluted enzyme-conjugate detection IFN-γ antibody will be added and incubated. The plates will be washed \& substrate added and allowed to develop for about 20 minutes. The development will be stopped by rinsing the plates in copious amounts of deionised water. The plates will be allowed to air dry in the dark and read using an ELISPOT reader within 12 hours. The results will be determined as spot forming units per one million cells
1 secondary outcome
Durability of the immune response measured up to 72 months quantitively by assessing the antibody concentration and qualitatively by assessing the antibody neutralization capacity. Curves will be drawn to represent immune responses against time
Time frame: 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon reasonable request. The request will be discussed within the trial consortium
Related trials for Sudan Ebola Virus Vaccines
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Sudan Virus Disease
Active, not recruitingPhase 2
A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Sudan Ebolavirus Vaccine in Healthy Adults
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CAd3, ChAdox1 and rVSV-SUDV in people with Sudan Ebola Virus Vaccines, run by Makerere University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce Kirenga, PhD (+256782404431, brucekirenga@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of solicited, unsolicited adverse and serious adverse events (safety) (time frame: 72 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.