Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General He… (NCT05724472) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Safety and Immunogenicity of rVSVΔG-SEBOV-GP Vaccine in Adults With Good General Health
United States36 participantsStarted 2023-06-19
Plain-language 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
Who can participate
Age range18 Years – 50 Years
SexALL
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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 seve…
What they're measuring
1
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Timeframe: 14 days
2
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Timeframe: 14 days
3
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine
Timeframe: 14 days
4
To evaluate the safety and tolerability of rVSVΔG-SEBOV-GP vaccine