Marburg Virus DiseasePhase 2NCT05817422
Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
A Phase 2 study testing cAd3-Marburg vaccine in people with Marburg Virus Disease, run by Albert B. Sabin Vaccine Institute at 2 sites in 2 countries.
Trial summary
A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Marburg Virus Disease
- What is being tested?
- cAd3-Marburg vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Oct 2023to 25 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to complete and provide written informed consent prior to any study procedure; including injection site photograph consent, completing an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions correctly at least once in 3 attempts, and including optional consent for retention of blood samples for potential future testing and assay development.
- Note: Participants can be enrolled even if they do not provide optional consent for retention of blood samples for potential future testing and assay development.
- Able to read and write the language used in diary card.
- Male or non-pregnant female 18 to 70 years of age (inclusive) at time of informed consent.
- 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.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
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- Has a means to be contacted and to contact the investigator during the study.
- Agree not to receive any vaccine within 28 days from study vaccination (prior and after), with the exception of an emergency use authorization or authorized non-adenoviral vectored coronavirus disease 2019 (COVID-19) vaccine, which may be given within 14 days of study vaccination.
- Agree not to donate bone marrow, blood, or blood products until 3 months after the study vaccination.
- 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.
- Clinical laboratory results within 28 days prior to vaccination within the site's laboratory reference ranges (or deemed not clinically significant by the principal investigator) for the following parameters: hematology (complete blood count (CBC) including hemoglobin, white blood cell (WBC), red blood cell (RBC), total lymphocyte count); coagulation tests (prothrombin time, international normalized ratio (INR), fibrinogen); chemistry (C-reactive protein, d-dimer, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine). A laboratory result that is outside the reference range and is deemed not clinically significant by the principal investigator will not exclude the participant.
- Has a body mass index (BMI) >17 and ≤37 at screening.
- Female participant specific criteria:
- Negative pregnancy serum test at screening, and negative urine pregnancy test before vaccination, if of reproductive potential.
- 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:
- At least 1 year postmenopausal.
- Surgically sterile.
- Male participants must agree:
- Not to father a child or donate sperm through study end.
- To use a barrier (condom) means of birth control from vaccination through study end, if assessed to be of reproductive potential.
Who cannot join
- Pregnant or lactating female or plans to become pregnant or breastfeed starting from study vaccination through to study end.
- Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. This includes any acute, subacute, intermittent, or chronic medical disease or condition that
- would place the participant at an unacceptable risk of injury,
- render the participant unable to comply with the requirements of the protocol,
- or may interfere with the evaluation of responses or the participant's successful completion of the trial; (chronic conditions that are well-controlled and medically stable, ie, no change in treatment for medical reasons occurred in the last 6 months, are allowed at the discretion of the principal investigator, eg, hypertension, asthma, thyroid disease).
- The medical disease or condition also includes any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (eg, malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (eg, medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
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- Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV 1 and 2, syphilis).
- Known prior exposure to MARV or prior diagnosis of Marburg virus disease (MVD).
- Current diagnosis of COVID-19 by reverse transcription polymerase chain reaction (RT-PCR) or antigenic testing or current signs and symptoms of COVID-19. Participants may be enrolled 14 days post resolution of all signs and symptoms of COVID-19 or of testing positive for COVID-19 in asymptomatic participants.
- History of or active status of any of the following clinically significant conditions:
- Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
- Allergic reaction to excipients in the study vaccine including gentamycin, neomycin or streptomycin or any other aminoglycoside.
- History of Diabetes mellitus Type I or Type II.
- Active Tuberculosis.
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
- Idiopathic urticaria within the last year.
- Bleeding disorder diagnosed by a doctor or use of anticoagulant medications such as, warfarin, apixaban, dabigatran (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- Major thrombotic event or heparin-induced thrombocytopenia or vaccine-induced thrombotic thrombocytopenia (VITT).
- History of malignancy of any organ system, treated or untreated, within the past 5 years from screening. (If diagnosed malignancy is 5 or more years prior to enrollment and cured with no ongoing treatment it will NOT be considered an exclusion).
- Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.
- Asplenia or functional asplenia.
- Autoimmune disease/autoinflammatory condition.
- Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
- 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 study vaccine, re-evaluation of eligibility may be performed at resolution of all signs and symptoms, and randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor (as appropriate).
- Receipt of any of the following substances:
- COVID-19 vaccine that has not received emergency use authorization or approval per local regulatory agency.
- Prior receipt of Ebola or Marburg vaccine.
- Prior receipt of any adenoviral-vectored vaccine, adenovirus-based or adeno-associated viruses (AAV)-based gene therapies or treatments, including adenoviral COVID-19 vaccines or boosters.
- Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) within 28 days of dosing or within washout period (5 half-lives) of such drug or has used an invasive investigational medical device within 28 days of dosing.
- Received investigational Ig or monoclonal antibodies within 3 months.
- Received convalescent serum for COVID-19 treatment within 3 months.
- Received an investigational vaccine within 3 months before the planned administration of the first dose of study vaccine.
- Is currently enrolled or plans to participate in another investigational or interventional study during this study (observational/registry studies are allowed).
- Use of immunomodulators or systemic glucocorticoids in daily doses of glucocorticoid equivalence >20 mg of prednisolone in the last 90 days, and for periods exceeding 10 days. NSAIDS are permitted.
- Receipt of blood products within 3 months prior to enrollment.
- Current anti-tuberculosis prophylaxis or therapy.
- Abnormality or permanent body art (such as tattoo) in deltoid region that would interfere with ability to observe or assess injection site reactions.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Kenya1 site
KEMRI/Centre for Respiratory Diseases Research Siaya Clinical Research Annex
Siaya
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
Read the detailed description
This is a multi-center, double-blinded, placebo-controlled, Phase II study to evaluate safety, tolerability, and immunogenicity of a single dose of cAd3-Marburg vaccine in healthy adults up to 70 years of age, in Uganda and Kenya. The study will enroll 125 eligible participants randomized 4:1 to receive the cAd3-Marburg vaccine at 1.0 × 10^11 PU dose or placebo (0.9% sodium chloride (NaCl) solution) at Day 1, intramuscularly in deltoid muscle. Participants will be screened for eligibility up to 28 days before enrollment. Enrollment will be staggered, starting with healthy adults 18 to 50 years of age (inclusive). Upon enrollment of minimum 25 younger adult participants (sentinel), the safety data up to 7 days post vaccination of these 25 sentinel participants will be reviewed by the independent DSMB. Progression to enrollment of the older adults (>50 to 70 years of age) will be dependent on the unblinded review of the Data Safety Monitoring Board (DSMB). Safety and immunogenicity will be assessed at Days 1, 8, 15, 29, 85, 169, and will conclude at the end of study visit on Day 366.
- Conditions
- Marburg Virus Disease
- Being tested
- cAd3-Marburg vaccine, Placebo
- Keywords
- Marburg virus, Marburg vaccine, cAd3-Marburg vaccine
- Medical subject headings
- Marburg Virus Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cAd3-Marburg vaccineBiological
The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP) from the Angola strain.
PlaceboOther
0.9% NaCl solution for injection.
| Study group | Role | What they receive |
|---|---|---|
| cAd3-Marburg vaccine (1.0 × 10^11 PU) | Experimental | Single dose of cAd3-Marburg vaccine (1x10^11 PU) administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL.
Placebo (0.9% NaCl solution for injection)administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL. Receives: Biological: cAd3-Marburg vaccine |
| Placebo | Placebo comparator | Single dose of Placebo (0.9% NaCl solution for injection) administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of cAd3-Marburg vaccine
Count and percentage of vaccinated participants who develop:
- serious adverse events (SAEs),
- solicited adverse events (AEs),
- unsolicited AEs,
- adverse event of special interest (AESI),
- medically attended adverse events (MAAE),
- AE at each intensity level.
Estimand 1a (Primary): Count and percentage of vaccinated participants who would develop SAEs, solicited AEs, unsolicited AEs, AESI, MAAE, and AE at each intensity level will be evaluated with each treatment group. A treatment policy strategy is used for assessing safety irrespective of a current (or prior) infection at time of the vaccination. Infections and death (if they meet the AE and time window criteria) are included in the endpoint (composite strategy).
Measured: 1 year
Secondary outcomes (1)
To evaluate the antibody response (IgG) to cAd3-Marburg vaccine at Day 29 post-vaccination.
Secondary Endpoint: GMC of anti-Marburg-GP binding IgG antibodies at Day 29 post-vaccination. Estimand 2a: geometric mean concentration (GMC) of the vaccine group will be compared to placebo at Day 29 post-vaccination. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-study vaccines. The principal stratum strategy excludes those with active or prior MARV infection at the time of the vaccination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start19 Oct 2023
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marburg Virus DiseaseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 4:1 to receive the cAd3-Marburg vaccine at 1.0 × 10\^11 PU dose or placebo at Day 1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert B. Sabin Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817422
- Sponsor's protocol ID
- Sabin 002
- Status last verified
- Jul 2025
- First submitted
- 5 Apr 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinic trial results will be published in a peer-reviewed journal, which will include, as feasible, the study protocol. A summary of the study results will be included within the trial registration records in ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT05817422
- Acronym / sponsor ID
- Sabin 002
- Conditions
- Marburg Virus Disease
- Keywords
- Marburg virus, Marburg vaccine, cAd3-Marburg vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Albert B. Sabin Vaccine InstituteUniversity, hospital or other
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 18 Apr 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.
A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults
Detailed description
This is a multi-center, double-blinded, placebo-controlled, Phase II study to evaluate safety, tolerability, and immunogenicity of a single dose of cAd3-Marburg vaccine in healthy adults up to 70 years of age, in Uganda and Kenya. The study will enroll 125 eligible participants randomized 4:1 to receive the cAd3-Marburg vaccine at 1.0 × 10^11 PU dose or placebo (0.9% sodium chloride (NaCl) solution) at Day 1, intramuscularly in deltoid muscle. Participants will be screened for eligibility up to 28 days before enrollment. Enrollment will be staggered, starting with healthy adults 18 to 50 years of age (inclusive). Upon enrollment of minimum 25 younger adult participants (sentinel), the safety data up to 7 days post vaccination of these 25 sentinel participants will be reviewed by the independent DSMB. Progression to enrollment of the older adults (>50 to 70 years of age) will be dependent on the unblinded review of the Data Safety Monitoring Board (DSMB). Safety and immunogenicity will be assessed at Days 1, 8, 15, 29, 85, 169, and will conclude at the end of study visit on Day 366.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 4:1 to receive the cAd3-Marburg vaccine at 1.0 × 10^11 PU dose or placebo at Day 1.
| Arm | Type | Receives |
|---|---|---|
| cAd3-Marburg vaccine (1.0 × 10^11 PU) | Experimental | Biological: cAd3-Marburg vaccineSingle dose of cAd3-Marburg vaccine (1x10^11 PU) administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL. Placebo (0.9% NaCl solution for injection)administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL. |
| Placebo | Placebo comparator | Other: PlaceboSingle dose of Placebo (0.9% NaCl solution for injection) administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Able and willing to complete and provide written informed consent prior to any study procedure; including injection site photograph consent, completing an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions correctly at least once in 3 attempts, and including optional consent for retention of blood samples for potential future testing and assay development.
- Note: Participants can be enrolled even if they do not provide optional consent for retention of blood samples for potential future testing and assay development.
- Able to read and write the language used in diary card.
- Male or non-pregnant female 18 to 70 years of age (inclusive) at time of informed consent.
- 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.
Key exclusion criteria (37 listed)
- Pregnant or lactating female or plans to become pregnant or breastfeed starting from study vaccination through to study end.
- Has any medical disease or condition that, in the opinion of the investigator, precludes study participation. This includes any acute, subacute, intermittent, or chronic medical disease or condition that
- The medical disease or condition also includes any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (eg, malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (eg, medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
- Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV 1 and 2, syphilis).
- Known prior exposure to MARV or prior diagnosis of Marburg virus disease (MVD).
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 |
|---|---|---|
| cAd3-Marburg vaccineThe recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP) from the Angola strain. | Biological | cAd3-Marburg vaccine (1.0 × 10^11 PU) |
| Placebo0.9% NaCl solution for injection. | Other | Placebo |
Primary outcome
To evaluate the safety and tolerability of cAd3-Marburg vaccine
Time frame: 1 year
Count and percentage of vaccinated participants who develop: * serious adverse events (SAEs), * solicited adverse events (AEs), * unsolicited AEs, * adverse event of special interest (AESI), * medically attended adverse events (MAAE), * AE at each intensity level. Estimand 1a (Primary): Count and percentage of vaccinated participants who would develop SAEs, solicited AEs, unsolicited AEs, AESI, MAAE, and AE at each intensity level will be evaluated with each treatment group. A treatment policy strategy is used for assessing safety irrespective of a current (or prior) infection at time of the vaccination. Infections and death (if they meet the AE and time window criteria) are included in the endpoint (composite strategy).
1 secondary outcome
To evaluate the antibody response (IgG) to cAd3-Marburg vaccine at Day 29 post-vaccination.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. The clinic trial results will be published in a peer-reviewed journal, which will include, as feasible, the study protocol. A summary of the study results will be included within the trial registration records in ClinicalTrials.gov.
Related trials for Marburg Virus Disease
Not yet recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants
Marburg Virus Disease (MVD)
Active, not recruitingPhase 1
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Marburg Virus Disease
Active, not recruitingPhase 2
A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Marburg Virus Vaccine in Healthy Adults
Marburg Virus Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cAd3-Marburg vaccine in people with Marburg Virus Disease, run by Albert B. Sabin Vaccine Institute at 2 sites in 2 countries.
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 20 inclusion and 37 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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of cAd3-Marburg vaccine (time frame: 1 year). 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 23 Jul 2025.