Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults

NCT05817422 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: Sabin 002
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 2

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

Conditions

Marburg Virus Disease

Keywords

Marburg virus; Marburg vaccine; cAd3-Marburg vaccine

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (1)

• To evaluate the antibody response (IgG) to cAd3-Marburg vaccine at Day 29 post-vaccination.

  6 months

Study Arms (2)

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.

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.

Other: Placebo

Interventions

cAd3-Marburg vaccine BIOLOGICAL

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.

cAd3-Marburg vaccine (1.0 × 10^11 PU)

Placebo OTHER

0.9% NaCl solution for injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Albert B. Sabin Vaccine Institute: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (2)

KEMRI/Centre for Respiratory Diseases Research Siaya Clinical Research Annex

Siaya, Kenya

Location

Makerere University-Walter Reed Project

Kampala, Uganda

Location

MeSH Terms

Conditions

Marburg Virus Disease

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections; Monkey Diseases; Primate Diseases; Animal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 4:1 to receive the cAd3-Marburg vaccine at 1.0 × 10\^11 PU dose or placebo at Day 1.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: October 19, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: We will also publish results in a manuscript in a peer reviewed journal, which requires a published study protocol. We expect this will be done either by early 2025.

Locations

KE (1); UG (1)