cAD3-Sudan Vaccine for Sudan Ebolavirus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine designed to protect against the Sudan Ebolavirus, focusing on its safety and immune response. Participants will receive either the investigational vaccine or a placebo (a shot with no active vaccine) to compare effects. The trial seeks healthy adults without recent vaccinations or certain medical conditions. Those in good health and without recent vaccines may qualify. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that the cAD3-Sudan Vaccine is likely to be safe for humans?
Research has shown that the cAD3-Sudan vaccine is generally safe for people. Studies have found that most individuals tolerate the vaccine well, experiencing no major issues. In earlier studies, participants had quick immune responses after just one shot. Importantly, no serious side effects related to the vaccine were reported. This suggests that the vaccine is safe for people, even though it is still undergoing testing.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for Sudan Ebolavirus, such as supportive care and experimental antivirals, the cAd3-Sudan Vaccine is a preventive approach designed to stimulate the immune system to fight the virus before infection occurs. This vaccine uses a modified virus to deliver genetic material that prompts the body to produce a strong immune response specifically against the Sudan strain of Ebolavirus. Researchers are excited because this targeted approach could provide immunity more effectively and safely than current options, potentially preventing outbreaks and saving lives.
What evidence suggests that the cAD3-Sudan Vaccine might be an effective treatment for Sudan Ebolavirus?
Research has shown that the cAD3-Sudan vaccine, which participants in this trial may receive, helps the body build a strong defense against the Sudan ebolavirus. In earlier studies, most people developed an immune response quickly after just one shot. The vaccine proved to be safe and easy to handle at different doses. These results suggest that the vaccine could effectively protect against the Sudan ebolavirus by strengthening the body's defenses.13456
Who Is on the Research Team?
Antonio Gonzalez-Lopez, MD, PhD, MPH
Principal Investigator
Albert B. Sabin Vaccine Institute
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of cAd3-Sudan vaccine or placebo intramuscularly on Day 1
Follow-up
Participants are monitored for safety and immunogenicity at multiple timepoints post-vaccination
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Single dose of cAd3-Sudan Vaccine (1x10\^11 PU) administered intramuscularly (IM) with needle and syringe in a volume of 0.83 mL.
Single dose of Placebo (0.9% NaCl solution for injection) administered intramuscularly (IM) with needle and syringe in a volume of 0.83 mL.
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Who Is Running the Clinical Trial?
Albert B. Sabin Vaccine Institute
Lead Sponsor
Biomedical Advanced Research and Development Authority
Collaborator
Citations
Safety, tolerability, and immunogenicity of the Ebola Sudan ...
The cAd3-EBO S vaccine was safe at both doses, rapidly inducing immune responses in most participants after a single injection. The rapid onset ...
Safety, tolerability, and immunogenicity of the Ebola Sudan ...
The cAd3-EBO S vaccine was safe at both doses, rapidly inducing immune responses in most participants after a single injection. The rapid onset and durability ...
Sabin Vaccine Institute Begins Phase 2 Clinical Trial for ...
Sabin Vaccine Institute launched a Phase 2 clinical trial for its vaccine against Sudan ebolavirus, with healthy volunteers receiving the single-dose vaccine.
Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are ...
In naïve participants, the cAd3-Ebola vaccines were more reactogenic than MVA-EbolaZ, in a dose-dependent manner. Higher rates of MVA-EbolaZ ...
Study Details | NCT06036602 | Monovalent Chimpanzee ...
This is a multi-center, double-blinded, placebo-controlled, Phase II study to evaluate safety, tolerability, and immunogenicity of a single dose of cAd3-Sudan ...
Sudan Ebolavirus Vaccine Development Program
Since no licensed vaccine exists, Sabin's R&D program is developing a chimpanzee-adenovirus type 3 (cAd3) vaccine to help protect against this deadly pathogen.
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