Lassa Fever
Conditions
Interventions
Vaccine
Sponsors
IAVI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults, adolescents, and children in good general health as assessed by medical history, physical examination, and laboratory tests who are =18 months and <71 years of age, who (themselves or as parents of minor children) are willing to comply with the requirements of the protocol and understand the information provided and potential impact and/or risks associated with the trial, are eligible to participate. People Living with HIV (PLWH) can also participate if they are on stable Highly Active Antiretroviral Therapy (HAART) therapy and meet specific criteria including viral load <50 copies/ml. Women of childbearing potential (WOCBP) must commit to use an effective method of contraception and all sexually active participants must be willing to use male or female condoms for 4 months after receipt of IP. Potential participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study.
Exclusion criteria
Exclusion criteria: 1. Potential participants will not be eligible to participate in this study if they have confirmed HIV-1 or HIV-2 infection (except for Group 2). 2. They will also be excluded if they have any clinically relevant abnormality on history or examination or have any clinically significant acute or chronic medical condition that is considered progressive (group-specific exceptions apply). 3. Participants must not be pregnant or lactating. 4. Except as specifically described in the protocol, if participants have a bleeding disorder, any acute or active chronic infectious disease, history of splenectomy or other immunocompromising as well as significantly abnormal laboratory parameters, they are also excluded. 5. They are excluded if they have recently received an investigational product (IP) in another clinical trial or have a history of severe local or systemic reactogenicity to vaccines. 6. Participants are not eligible if they report a history of symptomatic, diagnosed Lassa fever disease (LF), or Ebola virus disease (EVD), or have received a candidate vaccine against LF. 7. Participation will be deferred in case of other recent vaccinations. Body mass index (BMI) must be -2 SD from median for children and adolescents. 8. They should have no psychiatric condition or substance abuse in the last 3 years that compromises their safety, nor seizure disorder in the last 3 years. 9. Hearing must be normal for all participants or mildly reduced for adult participants aged 18 years and risk factors for hearing loss must be absent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Proportion of participants with Grade 3 or higher reactogenicity, ie, solicited AEs, within 14 days after IP administration •Proportion of participants with IP-related Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration •Proportion of participants with any Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration •Proportion of participants with IP-related SAEs throughout the study period •Proportion of participants with AESIs throughout the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of participants with binding antibody responses to LASV-GPC • Magnitude of binding antibody responses to LASV-GPC • Proportion of participants with neutralizing antibody responses against LASV • Magnitude of neutralizing antibody responses against LASV Vaccine Distribution and Shedding • Magnitude and duration of rVSV?G-LASV-GPC vaccine viremia by culture • Magnitude and duration of rVSV?G-LASV-GPC vaccine shedding in urine and saliva by culture • Assays may include: • Magnitude and duration of vaccine viral RNA in semen and cervicovaginal secretions by PCR . Magnitude and duration of rVSV?G-LASV-GPC vaccine shedding in semen and cervicovaginal secretions by culture | — |
Countries
Ghana, Liberia, Nigeria
Contacts
Public ContactGaudensia Mutua
IAVI Medical Director
Outcome results
None listed