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NCT05868733
A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa
Conditions: Lassa Fever
Sex: All
Ages: 6 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 530
Sponsor: International AIDS Vaccine Initiative
Location: Noguchi Memorial Institute for Medical Research (NMIMR) Accra
Summary
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults and Children Residing in West Africa
Eligibility Criteria
Inclusion Criteria:
* Adults, adolescents, and children in good general health as assessed by medical history and physical examination (group-specific criteria apply).
* At least 6 years old on the day of screening and not more than 70 years old on the day of vaccination (group-specific criteria apply).
* Participant or parent/guardian willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
* In the opinion of the Principal Investigator (PI) or designee and based on Assessment of Informed Consent Understanding (AOU), participant or parent/guardian has understood the information provided and potential impact and/or risks linked to administration and participation in the trial; written informed consent will be obtained before any study-related procedures are performed. Children old enough to understand the procedures will be asked to assent, in addition to parent/guardian consent, in accordance with local requirements.
* Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results (group-specific timepoints apply).
* All participants of child-bearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective hormonal contraception or intrauterine device beginning 2 weeks prior and extending for 4 months following receipt of vaccine/placebo. Study sites will choose which methods are most appropriate for their population and this will be specified in the Informed Consent Document (ICD).
* All sexually active participants must consistently use male or female condoms with all sexual partners for 4 months following IP administration.
* All participants who are not engaging in sexual activity that could lead to pregnancy at screening must agree to utilize an effective method of contraception if they begin engaging in sexual activity that could lead to pregnancy, as outlined above.
* All participants of childbearing potential must be willing to undergo a pregnancy test at time points indicated in the SOA.
* Willing to forgo donation of blood or any other tissues for transfusion or transplantation, from screening onward throughout the course of the study.
Additional Inclusion Criteria For HIV-Infected Participants
* Adults who are HIV-infected must meet the following additional inclusion criteria:
* Participant must be aged at least 18 years old on the day of screening and not more than 50 years old on the day of vaccination.
* Participant must have documented HIV-1 or HIV-2 infection for at least 6 months prior to screening.
* Participant must be on a stable (at least 6 months) regimen of Highly Active Antiretroviral Therapy (HAART), as defined as potent anti-HIV treatment including a combination of antiretroviral agents (pre- or post-exposure prophylaxis does not count as HAART).
* Participant entering the study should have a screening viral load \50years with the following chronic but controlled conditions may be enrolled:
* Hypertension with systolic ≤150 mmHg and/or diastolic ≤90 mmHg; (regardless of treatment status)
* Diabetes mellitus with a HbA1C \
Source: ClinicalTrials.gov (NCT05868733). StuddyBuddy aggregates publicly available trial information.