Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210840719552 Date of Registration: 19/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Phase 2 Lassa fever vaccine trial in adults and children residing in West Africa.
Official scientific title 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.
Brief summary describing the background and objectives of the trial rVSV∆G-LASV-GPC is a candidate vaccine that has been shown to be safe and protects against LF disease in animals. The vaccine is now being studied in an ongoing Phase 1 trial and has to date 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 rVSV∆G-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 rVSV∆G-LASV-GPC vaccine • To determine neutralizing LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine in a subset of participants in each group • To evaluate the magnitude and duration of the rVSV∆G-LASV-GPC vaccine viremia in plasma in a subset of participants. • To evaluate the magnitude and duration of the rVSV∆G-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 rVSV∆G-LASV-GPC vaccine in a subset of participants
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Lassa Fever
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/08/2023
Actual trial start date 06/03/2024
Anticipated date of last follow up 15/09/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 612
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
C105 Sponsor
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Diluent one dose one dose with 6 months of follow up intramuscular 102 Placebo
Experimental Group Vaccine one dose One dose with 6 months of follow up Intramuscular 510
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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 <35 for adults, and weight for height <2 standard deviation (SD) from median for adolescents. Weight for height/length 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. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 18 Month(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/01/2024 NREB National Research Ethics Board of Liberia
Ethics Committee Address
Street address City Postal code Country
21st Street, Sinkor, JFK Compound, Monrovia, Liberia Monrovia 0000 Liberia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/08/2023 NHREC National Health Research Ethics Committee of Nigeria
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health, Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja P.M.B. 083, Garki-Abuja Abuja 00000000 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/07/2023 NMIMR Noguchi Memorial Institute for Medical Research IRB
Ethics Committee Address
Street address City Postal code Country
University of Ghana Legon 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • 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 14-28 days with SAEs and AESIs measured throughout the study period
Secondary Outcome • 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 During the entire study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
PREVAIL John F Kennedy Medical Center 1st Floor, West Wing 21 Street Sinkor, Tubman Blvd Monrovia 231 Liberia
Walter Reed Program Nigeria 17 Takwa Crescent, Wuse 2 Abuja 234 Nigeria
Noguchi Memorial Institute for Medical Research College of Health Sciences, University of Ghana Accra 233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Coalition for Epidemic Preparedness Innovations Marcus Thranes gate 2, 0473 Oslo, Norway OSLO 0473 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor IAVI 125 Broad Street, 9th Floor NewYork, NY 10004 New York 10004 United States of America Non profit scientific research organization
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Gaudensia Mutua gmutua@iavi.org +254719043000 The Address, 11th Floor MuthangariDrive, Nairobi, Kenya
City Postal code Country Position/Affiliation
Nairobi Kenya IAVI Medical Director
Role Name Email Phone Street address
Principal Investigator Abdulwasiu Bolaji Tiamiyu atiamiyu@wrp-n.org 2348090236041 7 Usuma Street, Maitama
City Postal code Country Position/Affiliation
Abuja 234 Nigeria PI at Walter Reed Site
Role Name Email Phone Street address
Principal Investigator Johnson Kumblytee L kujohnson@prevailcr.org +231770185606 1st Floor, West Wing 21 Street Sinkor, Tubman Blvd
City Postal code Country Position/Affiliation
Monrovia 231 Liberia PI
Role Name Email Phone Street address
Principal Investigator Koram Kwadwo KKoram@noguchi.ug.edu.gh 233302501178 Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana,
City Postal code Country Position/Affiliation
Accra Ghana PI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Data Coordinating Center will conduct the data analysis and will provide interim and final study reports for the Sponsor, PI, the SMC, the IECs/IRBs and the regulatory authorities, as appropriate. A primary manuscript describing safety and immune responses in this trial will be prepared promptly after the data analysis is available. Authors will be representatives of each trial site, the data management and statistical analysis center, the laboratories and IAVI, subject to the generally accepted criteria of contributions to the design and conduct of the study, the analysis of data and writing of the manuscript. Manuscripts will be reviewed by representatives of each participating group as specified in the Clinical Trial Agreements. Study Protocol The clinical study report is anticipated to be completed within 6 months after database lock. Clinical data will be made publicly available, without personal identifiers, according to donor requirements.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information