Marburg Vaccine for Marburg Virus Disease

Recruiting at 3 trial locations

Overseen By Antonio Gonzalez Lopez, MD, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Albert B. Sabin Vaccine Institute

Must not be taking: Anticoagulants, Immunosuppressants, Corticosteroids, others

Disqualifiers: Diabetes, Tuberculosis, Seizure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 1 day

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, certain medications like systemic corticosteroids in high doses, anticoagulants, and some investigational drugs are not allowed. It's best to discuss your specific medications with the trial team.

How is the cAd3-Marburg vaccine different from other treatments for Marburg virus disease?

The cAd3-Marburg vaccine is unique because it uses a chimpanzee adenovirus vector to deliver a piece of the Marburg virus, which helps the body build immunity without causing the disease. Unlike other treatments, which are mainly supportive, this vaccine aims to prevent the disease by inducing strong immune responses, including both antibody and cell-mediated immunity, and it has shown promising results in early trials. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Antonio Gonzalez-Lopez, MD, PhD, MPH

Principal Investigator

Albert B. Sabin Vaccine Institute

Eligibility Criteria

This trial is for healthy adults who can participate in a study to test a new vaccine against Marburg virus. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the vaccine's evaluation.

Inclusion Criteria

I agree not to get any vaccines 3 months before or after the trial vaccine.

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

In good general health without clinically significant medical conditions as deemed acceptable by PI

Exclusion Criteria

I have a history of blood disorders or risks for blood clots.

History of allergy to any component of the vaccine

I have taken certain medications or substances as specified.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single dose of cAd3-Marburg vaccine or placebo intramuscularly on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity at multiple timepoints post-vaccination

52 weeks

Visits on Days 8, 15, 29, 85, 169, and 366

Treatment Details

Interventions

• cAd3-Marburg vaccine

Trial Overview The trial is testing the safety and immune response to a new Marburg virus vaccine called cAd3-Marburg. Participants will be randomly assigned to receive either the investigational vaccine or a placebo, without knowing which one they get.

Participant Groups

Group I: cAd3-Marburg vaccine (1.0 × 10^11 PU) Active Control 1 Intervention

Single dose of cAd3-Marburg vaccine (1x10\^11 PU) administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL.

Group II: Placebo 0.9% NaCl solution Placebo Group 1 Intervention

Single dose of Placebo (0.9% NaCl solution for injection) administered intramuscularly (IM) with needle and syringe in a volume of 0.56 mL.

Who Is Running the Clinical Trial?

Albert B. Sabin Vaccine Institute

Lead Sponsor

Trials

12

Recruited

7,200+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine in healthy adults in the USA: a first-in-human, phase 1, open-label, dose-escalation trial. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

De novo syntheses of Marburg virus antigens from adenovirus vectors induce potent humoral and cellular immune responses. [2006]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Single-Shot ChAd3-MARV Vaccine in Modified Formulation Buffer Shows 100% Protection of NHPs. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Recombinant Rabies Virus Expressing the Marburg Virus Glycoprotein Is Dependent upon Antibody-Mediated Cellular Cytotoxicity for Protection against Marburg Virus Disease in a Murine Model. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Complex adenovirus-vectored vaccine protects guinea pigs from three strains of Marburg virus challenges. [2019]