What side effects are associated with this type of intervention?

Common side effects for treatments similar to the rVSV[delta]G ZEBOV-GP (V920) vaccine, which stimulate the immune response to prevent infections, typically include mild to moderate adverse events such as injection site reactions (pain, redness, swelling), fever, headache, muscle pain, and fatigue. Serious adverse events are rare but can include severe allergic reactions. Monitoring for side effects is crucial, especially shortly after administration.

What prior FDA approvals exist?

The FDA has previously approved several vaccines and treatments that stimulate the immune response to prevent viral infections. For instance, the FDA approved the rVSV-ZEBOV (Ervebo) vaccine for Ebola virus, which is similar to the rVSV[delta]G ZEBOV-GP (V920) being studied. Additionally, the FDA has approved monoclonal antibodies like bamlanivimab and etesevimab for the prevention of COVID-19 in high-risk patients. These treatments work by enhancing the body's immune response to prevent infection.

What other types of research exist?

Promising novel alternatives to rVSV[delta]G ZEBOV-GP (V920) for preventing Ebola infection include the Ad26.ZEBOV/MVA-BN-Filo vaccine regimen and the Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) vaccine regimen. These vaccines have shown efficacy in clinical trials and are designed to stimulate a strong immune response against the Ebola virus.

← Back to Search

Virus Therapy

Ebola Vaccine for Occupational Exposure Prevention

Phase 2

Waitlist Available

Led By Richard T Davey, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

percutaneous contraceptive patches

Adults age greater than equal to 18 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 36

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a vaccine called rVSV[delta]G ZEBOV-GP (V920) designed to prevent Ebola. It targets healthy adults who might be exposed to Ebola at work. The vaccine uses a harmless virus that includes a part of the Ebola virus to help the body learn to fight it. Participants will be monitored over an extended period to see how well the vaccine works and how long its effects last. The rVSVΔG-ZEBOV-GP (V920) vaccine was approved by the FDA in December 2019 for the prevention of Ebola virus disease caused by Zaire ebolavirus.

Who is the study for?

Healthy adults over 18 at risk of Ebola exposure through work, willing to minimize blood and body fluid contact with others for 14 days post-vaccination. They must agree not to take other investigational drugs or donate blood for a year after vaccination, use effective contraception methods, and be non-pregnant and non-breastfeeding.

What is being tested?

The trial is testing the rVSV-Zebov GP vaccine's long-term effectiveness in preventing Ebola when given before exposure. Participants will receive an initial shot followed by monitoring visits over 36 months; half will get a booster dose at month 18.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever or fatigue, muscle pain, headache, and joint pain. Participants are asked to record any symptoms following vaccination in a provided diary card.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I use skin patches for birth control.

Select...

I am 18 years old or older.

Select...

I am currently using oral contraceptives.

Select...

I am currently using injectable birth control.

Select...

I have an implant of etonogestrel or levonorgestrel.

Select...

I am using an estrogen vaginal ring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of antibody titer levels between the boosted vs non-boosted groups

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Non-boosted GroupExperimental Treatment1 Intervention

Group randomized to 'no booster' at Month 18

Group II: Boosted GroupExperimental Treatment1 Intervention

Group randomized at Month 18 to receive booster vaccination

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for healthy subjects, such as the rVSV[delta]G ZEBOV-GP vaccine, work by stimulating the immune system to recognize and combat specific pathogens. The rVSV[delta]G ZEBOV-GP vaccine uses a recombinant vesicular stomatitis virus to express the Ebola virus glycoprotein, thereby inducing an immune response that prepares the body to fight off actual Ebola infections. This mechanism is crucial for healthy subjects as it provides pre-exposure prophylaxis, enabling their immune system to recognize and combat the virus before exposure, thereby preventing the disease.

Phase I study of VSV-GP (BI 1831169) as monotherapy or combined with ezabenlimab in advanced and refractory solid tumors.Oncolytic Viruses: Therapeutics With an Identity Crisis.