Marburg Virus DiseasePhase 2NCT06620003
A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational 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 7 sites in United States.
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
- 200 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Apr 2025to Oct 2026
- Phase
- Phase 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 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 informed consent prior to any trial procedure including optional consent for retention of blood samples for potential future testing and assay development. As part of the informed consent process, the participant must complete a Test of Understanding (ToU) about the study and answer at least 90% of the questions correctly at least once in three attempts.
- Male or non-pregnant female 18 to 70 (inclusive) years of age at time of consent;
- Is capable of understanding and agrees to comply with planned trial procedures and to be available for all clinic follow-up for all planned trial visits;
- Able to provide proof of identity to the satisfaction of the trial clinician completing the enrollment process; has a means to be contacted and to contact the investigator during the trial;
- Agree not to receive any vaccine within 3 months of trial vaccination (prior and after) trial;
- Agree not to donate bone marrow, blood, or blood products until 3 months after the trial vaccination;
Show all 18Show fewer
- 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 PI;
- Clinical laboratory results within 28 days prior to vaccination within the testing laboratory reference ranges (or deemed not clinically significant by the PI) for the following parameters: White blood cells (WBC), Complete blood count (CBC), Red blood cells (RBC), Hemoglobin (HGB), total lymphocyte count, coagulation tests to include prothrombin time in terms of INR, fibrinogen, protein C, d-dimer, and chemistry tests to include 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 PI 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 AND:
- Use of oral, implantable, transdermal or injectable contraceptives for 21 days prior to vaccination and for at least 24 weeks after vaccination, UNLESS the female participant fulfills one of the following criteria:
- At least 1 year post-menopausal.
- Surgically sterile.
- Use of another reliable form of contraception must be approved by the Investigator (e.g., double barrier method, intrauterine device, contraceptive patches).
- Male participants must agree:
- Not to father a child or donate sperm for at least 24 weeks after vaccination;
- To use an effective means of birth control from at least 21 days prior to vaccination and for at least 24 weeks after vaccination if assessed to be of reproductive potential.
Who cannot join
- Participant is female and is breastfeeding or plans to become pregnant or breastfeed from trial vaccination through 24 weeks post-vaccination
- Has any medical disease or condition that, in the opinion of the investigator, precludes trial 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 meet 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, i.e. no relevant change in treatment for medical reasons occurred in the last 6 months, are allowed at the discretion of the PI, e.g. hypertension, asthma, thyroid disease) Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, Human Immunodeficiency Virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders) and any infection requiring IV antibiotics or hospitalization within 90 days prior to screening
- History of Guillain-Barré syndrome
- History of allergy to any component of the vaccine
- Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV, Human T-cell leukemia virus (HTLV), Syphilis);
- Known prior exposure to Marburg virus or prior diagnosis of Marburg Virus Disease, determined from the participant's reported medical history
Show all 33Show fewer
- 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 trial vaccine including gentamycin, neomycin or streptomycin;
- Diabetes mellitus Type I or Type II (even if stable)
- Tuberculosis
- Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema;
- Idiopathic urticaria within the last year
- Any malignancy, including non-skin melanoma, that has been active or treated, within 5 years prior to screening. (If diagnosed malignancy is 5 or more years prior to enrollment and cured with no ongoing treatment the malignancy will NOT be considered an exclusion);
- Seizure in the past 3 years or treatment for seizure disorder in the past 3 years (even if stable);
- Asplenia or functional asplenia;
- 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;
- Hematologic History:
- Bleeding disorder diagnosed by a doctor or use of anticoagulant medications such as, Warfarin, Apixaban, Dabigatran (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws;
- Family and personal history of bleeding or thrombosis or heparin-induced thrombocytopenia
- Conditions known to increase risk of thrombosis (e.g., pregnant or post-partum, extreme obesity, active malignancy or post-transplantation, recent surgery, immobility, recent infection, recent head trauma, autoimmune disease, inflammatory disease),
- Receipt of blood products within 3 months prior to enrollment.
- Has donated ≥ 450 mL of blood products within 30 days prior to randomization or expects to donate blood within 90 days of vaccine administration
- History of heparin-related thrombotic events, and/or receiving heparin treatments
- Has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0° Celsius (≥100.4° Fahrenheit) within 24 hours of the planned dose of trial vaccine, rescreening and randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
- Receipt of any of the following substances:
- prior receipt of Sudan Virus Vaccine or Marburg Vaccine
- prior receipt of any adenoviral vectored vaccine, adenovirus-based or adeno-associated virus (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 3 months of dosing, or has used an invasive investigational medical device within 3 months of dosing
- received immunoglobulin (Ig) or monoclonal antibodies within 3 months,
- is currently enrolled or plans to participate in another investigational or interventional trial during the course of this trial (observational/registry trials are allowed)
- Use of systemic corticosteroids in daily dose equivalence > 20 mg of prednisolone in the last 90 days, and for periods exceeding 10 days. Non-steroidal anti-inflammatory drugs [NSAIDS] are permitted.
- Current anti-tuberculosis prophylaxis or therapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Synexus Clinical Research US, Inc.
Chicago, Illinois, 60602
Synexus Clinical Research US; Inc.
Dallas, Texas, 75234
Optimal Research; LLC
Huntsville, Alabama, 35802
Optimal Research; LLC
Melbourne, Florida, 32934
Optimal Research; LLC
Peoria, Illinois, 61614
Synexus Clinical Research US, Inc.
Phoenix, Arizona, 85020
Synexus Clinical Research US, Inc.
San Antonio, Texas, 78229
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 2 study to evaluate safety, tolerability, and immunogenicity of a single dose of cAd3-Marburg Vaccine in healthy adults 18 to 70 years of age, in a US-based population. The study will enroll 200 eligible participants randomized 4:1 to receive the cAd3-Marburg Vaccine at 1.0 × 10^11 PU/dose or placebo (normal saline; 0.9% sodium chloride (NaCl) solution for injection) at Day 1, intramuscularly, in deltoid muscle. Participants will be screened for eligibility up to 28 days before enrollment. Safety data will be periodically reviewed by an independent 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. PBMCs will be collected from a subset of 40 subjects on days 1, 15, 29, 169 and will conclude at the end of study visit on Day366 to access cellular immunity. All participants will also be contacted telephonically on Days 4 and 42 (unless a clinic visit is medically indicated, or participant does not have a phone contact) for safety follow-up.
- 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 Vaccine) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP) from the Angola strain.
PlaceboBiological
0.9% NaCl solution for injection.
| Study group | Role | What they receive |
|---|---|---|
| cAd3-Marburg Vaccine (1.0 × 10^11 PU) | Active comparator | Single dose of cAd3-Marburg Vaccine (1x10^11 PU) administered intramuscularly (IM) with needle and syringe in a volume of 0.71 mL. Receives: Biological: cAd3-Marburg Vaccine |
| Placebo 0.9% NaCl solution | Placebo comparator | Single dose of Placebo (0.9% NaCl solution for injection) administered intramuscularly (IM) with needle and syringe in a volume of 0.71 mL. Receives: Biological: 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, by count and percentage of vaccinated participants who develop: SAEs, solicited/unsolicited AEs, AESI, MAAE, and AE at each intensity level 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), and 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 vaccinated participants meet the AE and time window criteria) are included in the endpoint (composite strategy).
Measured: 1 Year
Secondary outcomes (10)
To determine the geometric mean concentration (GMC) of anti-Marburg-GP binding IgG antibodies to cAd3-Marburg Vaccine at Day 29 post-vaccination.
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine at Day 29 post-vaccination. Estimand 2a: Geometric mean concentration (GMC) of cAd3-Marburg Vaccine will be compared to placebo on 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-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the vaccination.
Measured: 29 Days
To determine geometric mean increase (GMI) of anti-Marburg-GP binding IgG antibodies at Day 29 post-vaccination
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine at Day 29 post-vaccination. Estimand 2b: Geometric mean increase (GMI) of anti-Marburg-GP binding IgG antibodies against Marburg-GP on Day 29. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the vaccination.
Measured: 29 Days
To determine the geometric mean of the ND50 (GMND50) of anti-Marburg-GP neutralizing antibodies on Day 29 post-vaccination.
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine at Day 29 post-vaccination. Estimand 2c: The geometric mean of the ND50 (GMND50) of anti-Marburg-GP neutralizing antibodies on Day 29. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the vaccination.
Measured: 29 Days
To determine the geometric mean increase of the ND50 (GMIND50) of anti-Marburg-GP neutralizing antibodies at Day 29 post-vaccination.
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine at Day 29 post-vaccination. Estimand 2d: The geometric mean increase of the ND50 (GMND50) of anti-Marburg-GP neutralizing antibodies on Day 29. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the vaccination.
Measured: 29 Days
To determine the percentage of participants (and 95%CI) with seroconversion at Day 29 post-vaccination.
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine at Day 29 post-vaccination. Estimand 2e: Percentage of participants (and 95%CI) with seroconversion at Day 29. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the vaccination.
Measured: 29 Days
To determine the geometric mean concentration (GMC) of anti-Marburg-GP binding IgG antibodies on Day 1, Day 8, Day 15, Day 85, Day 169, and Day 366.
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine across additional trial timepoints. Estimand 3a: GMCs of anti-Marburg-GP binding IgG antibodies on Day 1, Day 8, Day 15, Day 85, Day 169, and Day 366. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the trial intervention.
Measured: 1 Year
To determine the geometric mean increase (GMI) of anti-Marburg-GP binding IgG antibodies against Marburg-GP at optional selected timepoints (Day 8, Day 15, Day 85, Day 169, and Day 366).
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine across additional trial timepoints. Estimand 3b: GMI of anti-Marburg-GP binding IgG antibodies against Marburg-GP at optional selected timepoints (Day 8, Day 15, Day 85, Day 169, and Day 366). The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial intervention. The principal stratum strategy excludes those with active or prior MARV infection at the time of the trial intervention.
Measured: 1 Year
To determine geometric mean increase of the ND50 (GMIND50) of anti-Marburg-GP neutralizing antibodies on Day 1, Day 8, Day 15, Day 85, Day 169, and Day 366.
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine across additional trial timepoints. Estimand 3c: GMIND50 of anti-Marburg-GP neutralizing antibodies on Day 1, Day 8, Day 15, Day 85, Day 169, and Day 366. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the trial intervention.
Measured: 1 Year
To determine geometric mean increase of ND50 of anti-Marburg-GP neutralizing antibodies at optionally selected timepoints (Day 8, Day 15, Day 85, Day 169, and Day 366)
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine across additional trial timepoints. Estimand 3d: GMIND50 of anti-Marburg-GP neutralizing antibodies at optionally selected timepoints (Day 8, Day 15, Day 85, Day 169, and Day 366). The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the trial intervention.
Measured: 1 Year
To determine the percentage of participants (and 95%CI) with seroconversion at Day 8, Day 15, Day 85, Day 169, and Day 366.
Secondary Endpoint: To evaluate the humoral immunogenicity induced by cAd3-Marburg Vaccine across additional trial timepoints. Estimand 3e: Percentage of Participants (and 95%CI) with seroconversion at Day 8, Day 15, Day 85, Day 169, and Day 366. The hypothetical strategy is used to estimate antibody levels without subsequent Marburg virus (MARV) infection or influence from immune-modifying drugs or non-trial interventions. The principal stratum strategy excludes those with active or prior MARV infection at the time of the trial intervention.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start14 Apr 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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 (normal saline; 0.9% sodium chloride (NaCl) solution for injection) at Day 1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
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
- NCT06620003
- Sponsor's protocol ID
- Sabin-004
- Other IDs
- 75A50119C00055
- Status last verified
- Jan 2026
- First submitted
- 18 Sep 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical 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 10 Sep 2026. 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
- NCT06620003
- Acronym / sponsor ID
- Sabin-004
- Conditions
- Marburg Virus Disease
- Keywords
- Marburg Virus, Marburg Vaccine, cAd3-Marburg vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Albert B. Sabin Vaccine InstituteUniversity, hospital or other
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Oct 2024 (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 2 study to evaluate safety, tolerability, and immunogenicity of a single dose of cAd3-Marburg Vaccine in healthy adults 18 to 70 years of age, in a US-based population. The study will enroll 200 eligible participants randomized 4:1 to receive the cAd3-Marburg Vaccine at 1.0 × 10^11 PU/dose or placebo (normal saline; 0.9% sodium chloride (NaCl) solution for injection) at Day 1, intramuscularly, in deltoid muscle. Participants will be screened for eligibility up to 28 days before enrollment. Safety data will be periodically reviewed by an independent 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. PBMCs will be collected from a subset of 40 subjects on days 1, 15, 29, 169 and will conclude at the end of study visit on Day366 to access cellular immunity. All participants will also be contacted telephonically on Days 4 and 42 (unless a clinic visit is medically indicated, or participant does not have a phone contact) for safety follow-up.
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 (normal saline; 0.9% sodium chloride (NaCl) solution for injection) at Day 1.
| Arm | Type | Receives |
|---|---|---|
| cAd3-Marburg Vaccine (1.0 × 10^11 PU) | Active comparator | Biological: cAd3-Marburg VaccineSingle dose of cAd3-Marburg Vaccine (1x10^11 PU) administered intramuscularly (IM) with needle and syringe in a volume of 0.71 mL. |
| Placebo 0.9% NaCl solution | Placebo comparator | Biological: PlaceboSingle dose of Placebo (0.9% NaCl solution for injection) administered intramuscularly (IM) with needle and syringe in a volume of 0.71 mL. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Able and willing to complete and provide informed consent prior to any trial procedure including optional consent for retention of blood samples for potential future testing and assay development. As part of the informed consent process, the participant must complete a Test of Understanding (ToU) about the study and answer at least 90% of the questions correctly at least once in three attempts.
- Male or non-pregnant female 18 to 70 (inclusive) years of age at time of consent;
- Is capable of understanding and agrees to comply with planned trial procedures and to be available for all clinic follow-up for all planned trial visits;
- Able to provide proof of identity to the satisfaction of the trial clinician completing the enrollment process; has a means to be contacted and to contact the investigator during the trial;
- Agree not to receive any vaccine within 3 months of trial vaccination (prior and after) trial;
Key exclusion criteria (33 listed)
- Participant is female and is breastfeeding or plans to become pregnant or breastfeed from trial vaccination through 24 weeks post-vaccination
- Has any medical disease or condition that, in the opinion of the investigator, precludes trial 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 meet 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, i.e. no relevant change in treatment for medical reasons occurred in the last 6 months, are allowed at the discretion of the PI, e.g. hypertension, asthma, thyroid disease) Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, Human Immunodeficiency Virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders) and any infection requiring IV antibiotics or hospitalization within 90 days prior to screening
- History of Guillain-Barré syndrome
- History of allergy to any component of the vaccine
- Serology screen positive for infectious diseases (hepatitis B, hepatitis C, HIV, Human T-cell leukemia virus (HTLV), Syphilis);
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 Vaccine) 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. | Biological | Placebo 0.9% NaCl solution |
Primary outcome
To evaluate the safety and tolerability of cAd3-Marburg Vaccine, by count and percentage of vaccinated participants who develop: SAEs, solicited/unsolicited AEs, AESI, MAAE, and AE at each intensity level 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), and 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 vaccinated participants meet the AE and time window criteria) are included in the endpoint (composite strategy).
10 secondary outcomes
To determine the geometric mean concentration (GMC) of anti-Marburg-GP binding IgG antibodies to cAd3-Marburg Vaccine at Day 29 post-vaccination.
Time frame: 29 Days
To determine geometric mean increase (GMI) of anti-Marburg-GP binding IgG antibodies at Day 29 post-vaccination
Time frame: 29 Days
To determine the geometric mean of the ND50 (GMND50) of anti-Marburg-GP neutralizing antibodies on Day 29 post-vaccination.
Time frame: 29 Days
To determine the geometric mean increase of the ND50 (GMIND50) of anti-Marburg-GP neutralizing antibodies at Day 29 post-vaccination.
Time frame: 29 Days
To determine the percentage of participants (and 95%CI) with seroconversion at Day 29 post-vaccination.
Time frame: 29 Days
To determine the geometric mean concentration (GMC) of anti-Marburg-GP binding IgG antibodies on Day 1, Day 8, Day 15, Day 85, Day 169, and Day 366.
Time frame: 1 Year
To determine the geometric mean increase (GMI) of anti-Marburg-GP binding IgG antibodies against Marburg-GP at optional selected timepoints (Day 8, Day 15, Day 85, Day 169, and Day 366).
Time frame: 1 Year
To determine geometric mean increase of the ND50 (GMIND50) of anti-Marburg-GP neutralizing antibodies on Day 1, Day 8, Day 15, Day 85, Day 169, and Day 366.
Time frame: 1 Year
To determine geometric mean increase of ND50 of anti-Marburg-GP neutralizing antibodies at optionally selected timepoints (Day 8, Day 15, Day 85, Day 169, and Day 366)
Time frame: 1 Year
To determine the percentage of participants (and 95%CI) with seroconversion at Day 8, Day 15, Day 85, Day 169, and Day 366.
Time frame: 1 Year
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. The clinical 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
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.
7 sites in 1 country: 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 7 sites in United States.
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 18 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
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?
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, by count and percentage of vaccinated participants who develop: SAEs, solicited/unsolicited AEs, AESI, MAAE, and AE at each intensity level 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 10 Sep 2026.