cAD3-Sudan Vaccine for Sudan Ebolavirus

Recruiting in Peoria (>99 mi)

+3 other 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

Do I need to stop my current medications to join the trial?

The trial protocol 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.

What data supports the effectiveness of the cAD3-Sudan Vaccine treatment for Sudan Ebolavirus?

The cAD3-Sudan Vaccine is similar to the cAd3-EBO vaccine, which has shown protection in nonhuman primates and was rapidly advanced into clinical trials for Ebola virus, suggesting potential effectiveness for Sudan Ebolavirus. ^{1 2 3 4 5}

Is the cAD3-Sudan Vaccine safe for humans?

The cAD3-Sudan Vaccine, similar to other adenovirus-based Ebola vaccines, has been tested in humans and shown to be safe, with participants developing immune responses without serious side effects. ^{4 5 6 7 8}

How is the cAD3-Sudan Vaccine different from other treatments for Sudan Ebolavirus?

The cAD3-Sudan Vaccine is unique because it uses a chimpanzee adenovirus vector to deliver the Sudan Ebolavirus glycoprotein, aiming to induce a strong immune response. Unlike other treatments, it specifically targets the Sudan strain of the virus, for which there are currently no approved vaccines. ^{1 2 4 8 9}

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 Sudan Ebolavirus Vaccine in Healthy Adults

Research Team

Antonio Gonzalez-Lopez, MD, PhD, MPH

Principal Investigator

Albert B. Sabin Vaccine Institute

Eligibility Criteria

Healthy adults aged 18-70 who agree not to receive other vaccines 3 months before and after the trial vaccine, have normal lab results, a BMI between >17 and ≤37, are not pregnant or breastfeeding, use specified contraceptives, and have no significant medical conditions. Excludes those with certain diseases or allergies.

Inclusion Criteria

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

Clinical laboratory results within 28 days prior to vaccination within the testing laboratory reference ranges (or deemed not clinically significant by the PI) for specified parameters

Has a body mass index (BMI) >17 and ≤ 37 at screening

Exclusion Criteria

Serology screen positive for specified infectious diseases

I haven't had a fever or serious illness in the last 24 hours.

I am breastfeeding or plan to become pregnant or breastfeed during the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single dose of cAd3-Sudan 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-Sudan Vaccine

Trial Overview The trial is testing a new Ebola Sudan virus vaccine called cAD3-Sudan against a placebo in healthy adults. It's randomized and double-blind, meaning participants don't know if they're getting the real vaccine or a dummy shot.

Participant Groups

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

Single dose of cAd3-Sudan vaccine (1x10\^11 PU) administered intramuscularly (IM) with needle and syringe in a volume of 0.71 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 0.0.71 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. United States pubmed.ncbi.nlm.nih.gov

Chimpanzee Adenovirus Vector Ebola Vaccine. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Species-specific immunogenicity and protective efficacy of a vesicular stomatitis virus-based Sudan virus vaccine: a challenge study in macaques. [2023]

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

Ebola virus vaccines: Where do we stand? [2017]

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

Use of ChAd3-EBO-Z Ebola virus vaccine in Malian and US adults, and boosting of Malian adults with MVA-BN-Filo: a phase 1, single-blind, randomised trial, a phase 1b, open-label and double-blind, dose-escalation trial, and a nested, randomised, double-blind, placebo-controlled trial. [2022]

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

Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial. [2023]

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

Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A replication defective recombinant Ad5 vaccine expressing Ebola virus GP is safe and immunogenic in healthy adults. [2020]

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

Development of a cAdVax-based bivalent ebola virus vaccine that induces immune responses against both the Sudan and Zaire species of Ebola virus. [2018]

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

Safety, tolerability, and immunogenicity of the Ebola Sudan chimpanzee adenovirus vector vaccine (cAd3-EBO S) in healthy Ugandan adults: a phase 1, open-label, dose-escalation clinical trial. [2023]