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, 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
2 other identifiers
interventional
200
1 country
7
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2025
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
April 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 26, 2026
January 1, 2026
1.5 years
September 18, 2024
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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.
29 Days
To determine geometric mean increase (GMI) of anti-Marburg-GP binding IgG antibodies at Day 29 post-vaccination
29 Days
To determine the geometric mean of the ND50 (GMND50) of anti-Marburg-GP neutralizing antibodies on Day 29 post-vaccination.
29 Days
To determine the geometric mean increase of the ND50 (GMIND50) of anti-Marburg-GP neutralizing antibodies at Day 29 post-vaccination.
29 Days
To determine the percentage of participants (and 95%CI) with seroconversion at Day 29 post-vaccination.
29 Days
- +5 more secondary outcomes
Other Outcomes (3)
To determine cell-mediated immune response to cAd3-Marburg Vaccine at Day 1, Day 15, Day 29, Day 169, and Day 366 in a subset of 40 Participants
1 Year
To determine the geometric mean concentration (GMC) of anti-Marburg-GP binding IgM antibodies at Day 1, Day 8, Day 15, and Day 29.
29 Days
To determine Systems serology (multiple assays in high throughout screen) D1 and D29
29 Days
Study Arms (2)
cAd3-Marburg Vaccine (1.0 × 10^11 PU)
ACTIVE COMPARATORSingle 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 COMPARATORSingle dose of Placebo (0.9% NaCl solution for injection) administered intramuscularly (IM) with needle and syringe in a volume of 0.71 mL.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- 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).
- +3 more criteria
You may not qualify if:
- 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
- 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
- Seizure in the past 3 years or treatment for seizure disorder in the past 3 years (even if stable);
- Asplenia or functional asplenia;
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Optimal Research; LLC
Huntsville, Alabama, 35802, United States
Synexus Clinical Research US, Inc.
Phoenix, Arizona, 85020, United States
Optimal Research; LLC
Melbourne, Florida, 32934, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, 60602, United States
Optimal Research; LLC
Peoria, Illinois, 61614, United States
Synexus Clinical Research US; Inc.
Dallas, Texas, 75234, United States
Synexus Clinical Research US, Inc.
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2024
First Posted
October 1, 2024
Study Start
April 14, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- The sponsor will also publish results in a manuscript in a peer reviewed journal, which requires a published study protocol. The sponsor expects this will be done by early 2027.
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.