A Lassa Fever Vaccine Trial in Adults and Children Residing in West Africa
NCT ID: NCT05868733
Last Updated: 2025-05-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
612 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-03-06
Study Completion Date
2027-04-30
Brief Summary
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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
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Detailed Description
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rVSVΔG-LASV-GPC is a candidate vaccine that has been shown to be safe and protects against LF disease in animals. The vaccine was studied studied in a Phase 1 trial and has been well tolerated and immunogenic. This Phase 2 trial will add to data from the Phase 1 trial to establish a broader profile of safety and immunogenicity in adults and expand the population to include a subset of adults with HIV infection as well as older adults and healthy children, in preparation for an efficacy trial in West Africa. Primary Objective: • To evaluate the safety and tolerability of rVSVΔG-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children Secondary Objectives: • To determine binding LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine • To determine neutralizing LASV-GPC-specific antibody responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants in each group • To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine viremia in plasma in a subset of participants. • To evaluate the magnitude and duration of the rVSVΔG-LASV-GPC vaccine shedding in saliva and urine, and possibly semen and cervicovaginal fluid, in a subset of participants Exploratory Objective • To explore the characteristics of the immune responses induced by rVSVΔG-LASV-GPC vaccine in a subset of participants
Conditions
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Lassa Fever
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study staff and participants will be blinded in terms of active product versus placebo.
Study Groups
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Cohort 1A
Healthy Adults, 18-70yrs
Group Type
EXPERIMENTAL
Day 1 Lower Dose (2×106 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 2A
HIV-infected Adults, 18-50yrs
Group Type
EXPERIMENTAL
Day 1 Lower Dose (2×106 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 3A
Adolescents, 12 17yrs
Group Type
EXPERIMENTAL
Day 1 Lower Dose (2×106 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 4A
Children, 6-11yrs
Group Type
EXPERIMENTAL
Day 1 Lower Dose (2×106 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 5A
Children, 18mos-5yrs
Group Type
EXPERIMENTAL
Day 1 Lower Dose (2×106 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 1B
Healthy Adults, 18-70yrs
Group Type
EXPERIMENTAL
Day 1 Higher Dose (1×107 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 2B
HIV-infected Adults,18-50yrs
Group Type
EXPERIMENTAL
Day 1 Higher Dose (1×107 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 3B
Adolescents, 12 17yrs
Group Type
EXPERIMENTAL
Day 1 Higher Dose (1×107 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 4B
Children, 6-11yrs
Group Type
EXPERIMENTAL
Day 1 Higher Dose (1×107 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Cohort 5B
Children, 18mos-5yrs
Group Type
EXPERIMENTAL
Day 1 Higher Dose (1×107 pfu)
Intervention Type
DRUG
rVSV∆G-LASV-GPC
Placebo
Intervention Type
DRUG
Placebo
Interventions
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Day 1 Lower Dose (2×106 pfu)
rVSV∆G-LASV-GPC
Intervention Type
DRUG
Day 1 Higher Dose (1×107 pfu)
rVSV∆G-LASV-GPC
Intervention Type
DRUG
Placebo
Placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 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 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.
* 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 \<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, medical history, and the investigator's clinical judgment.
* 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 participate in the study. Assent must be obtained from adolescents and children in accordance with local regulations and practice. Parent(s)/legal guardian must pass the AOU.
* 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.
* 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 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.
* 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 \<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, medical history, and the investigator's clinical judgment.
* 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 participate in the study. Assent must be obtained from adolescents and children in accordance with local regulations and practice. Parent(s)/legal guardian must pass the AOU.
* 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.
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 considered significant by the Investigator within the previous 6 months. The following exceptions are permitted and will not preclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on Investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
* 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 \>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 \<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 bleeding but does not have a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.
* 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 syphilis (positive screening and confirmatory tests unless adequately treated), positive viral detection test for SARS-CoV-2. Note: COVID-19 screening is not applicable for Group 5.
* 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 vaccines such as VSV-ZEBOV will be documented but is not an exclusion criterion.
* 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 Monitor gives approval.
* 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, ongoing risk for suicide, or history of suicide attempt or gesture 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 seizures is an exclusion criterion.
* 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 entry will be assessed retrospectively and will not be a basis for exclusion.
* 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 WHO growth charts
* 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 follow pure tone audiometry procedure) "refer" test results as determined by OAE.
* 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 excluded)
* 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 during the study.
* 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.
* 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 considered significant by the Investigator within the previous 6 months. The following exceptions are permitted and will not preclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on Investigator clinical judgment) at least 2 weeks prior to enrollment in this study.
* 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 \>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 \<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 bleeding but does not have a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible.
* 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 syphilis (positive screening and confirmatory tests unless adequately treated), positive viral detection test for SARS-CoV-2. Note: COVID-19 screening is not applicable for Group 5.
* 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 vaccines such as VSV-ZEBOV will be documented but is not an exclusion criterion.
* 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 Monitor gives approval.
* 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, ongoing risk for suicide, or history of suicide attempt or gesture 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 seizures is an exclusion criterion.
* 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 entry will be assessed retrospectively and will not be a basis for exclusion.
* 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 WHO growth charts
* 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 follow pure tone audiometry procedure) "refer" test results as determined by OAE.
* 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 excluded)
* 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 during the study.
* 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.
Minimum Eligible Age
18 Months
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Coalition for Epidemic Preparedness Innovations
OTHER
Sponsor Role
collaborator
International AIDS Vaccine Initiative
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Noguchi Memorial Institute for Medical Research (NMIMR)
Accra, , Ghana
Site Status
RECRUITING
PREVAIL_ John F. Kennedy Medical Center (JFK)
Monrovia, , Liberia
Site Status
RECRUITING
Walter Reed Program - Nigeria
Wuse, , Nigeria
Site Status
RECRUITING
Countries
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Ghana
Liberia
Nigeria
Central Contacts
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Facility Contacts
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Other Identifiers
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IAVI C105
Identifier Type: -
Identifier Source: org_study_id
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Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
NCT00780806
COMPLETED
PHASE1/PHASE2
Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects
NCT01519713
COMPLETED
PHASE3
Evaluation of Medical Conditions Associated With Zika Virus Infection in Managua, Nicaragua
NCT04182685
COMPLETED
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
NCT01430611
COMPLETED
PHASE4
Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa
NCT05794230
COMPLETED
PHASE3
A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years
NCT06106581
COMPLETED
PHASE2
Prospective Safety Cohort Study After VLA1553 Vaccination in Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil
NCT07254702
NOT_YET_RECRUITING
Immunogenicity of SA 14-14-2 JE Vaccine
NCT01635816
COMPLETED
PHASE4
Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese
NCT03714737
COMPLETED
PHASE3