Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1, Single-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine at 3 Dose Levels in Adults in Good General Health

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: International AIDS Vaccine Initiative
• Collaborator: Biomedical Advanced Research and Development Authority

Criteria

Inclusion:

• Good general health

• ≥18 years of age on the day of screening and are ≤50 years of age on the day of IP administration

• Adherence to the requirements of the protocol and the follow-up for the planned duration of the study

• Undergo HIV testing, risk reduction counseling, and receive HIV test results

• As applicable use male or female condoms for 1 month following IP administration

• Use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine

• As applicable undergo urine pregnancy tests

• Forgo donation of blood or any other tissues throughout the course of the study

Exclusion:

• Any clinically relevant abnormality

• Any clinically significant acute or chronical medical condition

• Women who are pregnant or breastfeeding

• Bleeding disorder

• Infectious disease

• History of splenectomy

• Receipt of any vaccine within the previous 28 days or planned receipt within 28 days after vaccination with IP.

• Receipt of blood transfusion or blood-derived products within 3 months prior to screening

• Prior exposure to SEBOV or history of any hemorrhagic fever

• Prior receipt of any VSV-vectored vaccine

• Receipt of another IP within 3 months prior to enrollment or expected participation during this study.

• Prior receipt of another Sudan Ebola vaccine or receipt of polyclonal or monoclonal antibodies directed against Sudan Ebola in the past 6 months

• History of severe reactogenicity to vaccines or severe allergy to food or medications

• A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy.

• Serious infections requiring antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment

• Body mass index (BMI) ≥35

• Current or planned occupational or household contact from screening through 3 months after vaccine administration with any immunocompromised individual