A Phase 1 Randomized, Blinded, Placebo Controlled, Dose-Escalation and Dosing Regimen Selection Study to Evaluate the Safety and Immunogenicity of rVSV-Vectored Lassa Virus Vaccine in Healthy Adults at Multiple Sites in West Africa

September 12, 2022 | Ongoing Project | Reading time: 6 min

Investigators

Dr. Seyram Kaali, Dr. Kwaku Poku Asante, Dr. Samuel Harrison, Dr. Prince Agyapong Darko, Dr. Felicia Serwah, Mr. Elvis Wilson, Dr. Afia Korkor Opare Yeboah, Dr. Dennis Adu-Gyasi, Mr. Kingsley Kayan, Mr. Farrid Boadu, Dr. David Dosoo, Mr. Zakariah Buwah, Mr. Francis Kornu Mensah, Mr. Elisha Adeniji, Mr. Richard Boakye

Background
Lassa fever is an acute viral illness caused by the Lassa virus. The disease occurs in many West African countries including Ghana. The illness begins gradually with non-specific symptoms such as fever, general weakness and malaise followed by headache, sore throat, muscle pain, chest pain, nausea, vomiting, diarrhea cough and abdominal pain. Complications include bleeding, shock, seizure and hearing loss. About 80% of infections are asymptomatic or mild. There is currently no specific treatment or approved vaccine to protect against disease caused by the Lassa fever virus, and 15% of hospitalized cases succumb to the disease.

The study is testing multiple doses of a candidate vaccine for the first time in humans to ascertain its safety and immunogenicity and to select an appropriate dosing regimen for testing in subsequent phases of clinical trials. The candidate vaccine consists of a harmless virus called vesicular stomatitis virus that has been genetically engineered to produce antigens of the Lassa virus when injected into the body.

Objective
The primary safety objective of the study is to evaluate the safety and tolerability of increasing dose levels of the investigational vaccine. The primary immunogenicity objective is to evaluate the antibody response to the vaccine at various dose levels.

Expected Outcome
Safety outcomes include incidence of reactogenicity events occurring within 7 days of each vaccination, incidence of adverse events, serious adverse events and adverse events of special interest. Immunogenicity outcomes include levels of Lassa virus neutralizing antibodies Lassa virus specific T cell responses.

Collaborators
Navrongo Health Research Centre

Funders:Emergent Product Development Gaithersburg, Inc