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New treatment option for Lassa Fever
Official title A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa
ClinicalTrials.gov ID: NCT05868733
What this study is testing
What is Day 1 Lower Dose (2×106 pfu)?
Day 1 Lower Dose (2×106 pfu) is an investigational medicine, being studied as a potential treatment for lassa fever.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Adults, adolescents, and children in good general health as assessed by medical history and physical examination (group-specific criteria apply).
- At least 18 months 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...
- In the opinion of the Principal Investigator (PI) or designee and based on Assessment of Informed Consent Understanding (AOU), participant or...
- Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results (group-specific timepoints apply).
You likely can't join if
- #9 will apply. Exclusion Criteria:
- Confirmed HIV-1 or HIV-2 infection (except as outlined for Group 2)
- Any clinically relevant abnormality on history or examination including history of immunodeficiency (except for Group 2) or autoimmune disease; use...
- Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in...
- Hypertension with systolic ≤150 mmHg and/or diastolic ≤90 mmHg; (regardless of treatment status)
- Diabetes mellitus with a HbA1C \<10% and /or with type 2 diabetes mellitus on stable medication for at least 2 months prior to enrollment.
See the full eligibility criteria
Who can join
- Adults, adolescents, and children in good general health as assessed by medical history and physical examination (group-specific criteria apply).
- At least 18 months 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...
- 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...
- 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...
- 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 For HIV-Infected Participants
- Adults who are HIV-infected must meet the following additional
- 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...
- Participant entering the study should have a screening viral load \<50 copies/ml.
- Participant must be willing to continue their HAART and HIV care follow up throughout the study as directed by their regular caregiver and be willing to give access to records of their ongoing care.
- Participant must be in an otherwise reasonably good medical condition (absence of acquired immunodeficiency syndrome [AIDS]-defining illnesses or clinically significant disease), diagnosed based on physical examination...
- Each potential pediatric study participant must meet all of the following additional criteria to be enrolled in the study:
- Parent(s)/legal guardian must have signed an ICD indicating that they understand the purpose and procedures required for the study, are willing/able to adhere to the study requirements and are willing for their child to...
- Participant's age on the day of vaccination is within one of the 3 age strata in the study: 12-17 years, 6-11 years, or 18 months -5 years.
- Participant must be healthy in the investigator's clinical judgment (and the parent(s)/legal guardian's judgment) based on medical history, physical examination and vital signs performed at screening.
- A female adolescent who is of childbearing potential must comply with requirements for contraception.
- Adolescents who are sexually active must comply with requirement for use of condoms for 4 months after vaccination.
- Participant has received all routine immunizations appropriate for their age as reported by the parent(s)/legal guardian, according to local routine vaccination schedules. Participants are allowed to catch up on routine...
What rules you out
- #9 will apply. Exclusion Criteria:
- Confirmed HIV-1 or HIV-2 infection (except as outlined for Group 2)
- Any clinically relevant abnormality on history or examination including history of immunodeficiency (except for Group 2) or autoimmune disease; use of corticosteroids, immunosuppressive, anticancer, or other medications...
- Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study (except for HIV in Group 2). Note: Participants aged...
- Hypertension with systolic ≤150 mmHg and/or diastolic ≤90 mmHg; (regardless of treatment status)
- Diabetes mellitus with a HbA1C \<10% and /or with type 2 diabetes mellitus on stable medication for at least 2 months prior to enrollment.
- Pregnant or lactating.
- Bleeding disorder that was diagnosed by a physician (eg, factor deficiency, coagulopathy, or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or...
- Infectious disease: chronic active hepatitis B infection (HBsAg-positive), current hepatitis C infection, prior clinical diagnosis of Lassa Fever disease (LF) or Ebola virus disease (EVD) by medical history, active...
- History of splenectomy or functional asplenia.
- Any of the following abnormal laboratory parameters listed below:
- Hematology
- Absolute Neutrophil Count (ANC): ≤1,000 cells/mm3 or ≤ 1.0 × 109 cells/L
- Absolute Lymphocyte Count (ALC): ≤650 cells/mm3 or ≤ 0.65 × 109 cells/L
- Hemoglobin: \<9.5 g/dl in females; \<11.0 g/dl in males; \<10 g/dl in children \<11 years of age
- Platelets \<100,000 cells/mm3
- Chemistry
- Creatinine \>1.1 x upper limit of normal (ULN) (Note: For participants aged \>50 years clinically insignificant renal insufficiency defined as creatinine ≤1.3 x ULN is allowed)
- Alanine transaminase (ALT) \>1.25 x ULN
- Aspartate transaminase (AST) \>1.25 x ULN
- Urinalysis (not applicable for group 5)
- Clinically significant abnormal dipstick confirmed by repeat dipstick on new specimen or by microscopy
- Protein = 1+ or more
- Blood = 2+ or more (not due to menses) (Urinalysis may be collected within the following 2 weeks if menses interfere)
- Receipt of any vaccine within the previous 28 days or planned receipt within 28 days after vaccination with IP. Participation may be delayed until this criterion can be fulfilled. Note: prior receipt of VSV-vectored...
- Prior receipt of another investigational Lassa vaccine candidate. Note: receipt of placebo in a previous LF vaccine trial will not exclude a participant from participation if documentation is available and the Medical...
- Receipt of blood transfusion or blood-derived products within the previous 3 months.
- Participation in another clinical trial or observational study currently, within the previous 3 months, or expected participation during this study, unless Medical Monitor approves.
- History of severe local or systemic reactogenicity to any vaccine (eg, anaphylaxis, respiratory difficulties, angioedema, injection site necrosis, or ulceration).
- Psychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with psychoses in the last 3 years prior to screening...
- Seizure disorder: A participant who has had a seizure in the last 3 years prior to screening or has been on any medication to control or prevent seizures for the last 3 years is excluded. Group 5: History of febrile...
- A history of malignancy in the past 5 years (prior to screening) or ongoing malignancy (a history of a completely excised malignancy that is considered cured is not an exclusion).
- Active, serious infections requiring parenteral antibiotic, antiviral, antiparasitic or antifungal therapy within 30 days prior to enrollment (except HAART treatment in Group 2). Asymptomatic malaria infection at study...
- Group specific weight for height restrictions as indicated below:
- Groups 1 and 2: Obesity as defined by Body mass index (BMI) ≥35.
- Group 3: Obesity as defined by weight for height 2 standard deviation (SD) from median according to WHO growth charts or underweight as defined by weight for height or weight for length ≤-2 SD from median according to...
- Groups 4 and 5: Underweight as defined by weight for height or weight for length ≤ 2 SD from median according to WHO growth charts (see APPENDIX C) and/or weighing \<10kg.
- Group specific hearing thresholds or otoacoustic emission (OAE) results at 0.5-4KHz as indicated below:
- Moderate or greater hearing impairment defined as 35dB in any frequency in either ear as revealed via the audiometry exam for Groups 1 and 2.
- Mild or greater hearing impairment defined as ≥20dB in any frequency in either ear as revealed via the audiometry exam for adolescents and children aged \>7years. For children 7 years of age and younger (or unable to...
- Otorrhea within the past 90 days, sudden or rapid hearing loss within the past 90 days, acute or chronic dizziness, otalgia (external ear otalgia is not an exclusion)
- Clinically relevant abnormal otoscopy, that in the opinion of the investigator, may interfere with hearing. (Participants with conditions that can be treated prior to enrolment such as cerumen obstruction are not...
- History of acute or chronic or severe neurologic condition (eg, diagnosis of Guillain-Barré syndrome, epilepsy, Bell's palsy, meningitis, or disease with any focal neurologic deficits).
- Current of past significant risk factors for hearing loss (eg, occupational exposure to loud noise or medical illness) that, in the opinion of the investigator, may interfere with the detection of changes in hearing...
- History of any condition associated with sensorineural hearing loss that, in the opinion of the investigator, may cause changes in hearing during the study (eg, occupational exposure to loud noise or medical illness).
- If, in the opinion of the PI, it is not in the best interest of the participant to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Accra, Ghana
- Monrovia, Liberia
- Wuse, Nigeria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 months to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Accra, Ghana; Monrovia, Liberia; Wuse, Nigeria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.