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.: PACTR202106625781067 Date of Approval: 08/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health
Official scientific title A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health
Brief summary describing the background and objectives of the trial Lassa fever (LF) is a severe viral disease endemic to West African countries with up to 500 000 LF cases and 10 000 deaths annually. Given the potential of Lassa virus to cause a public health emergency, it was included in the 2018 WHO R&D Blueprint of diseases for which there is an urgent need for accelerated research and development. IAVI proposes to assess the safety and immunogenicity of a Lassa vaccine candidate (rVSV∆G-LASV- glycoprotein precursor [GPC]) based on the recombinant vesicular stomatitis virus (rVSV) platform technology. Primary objective: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
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 18/06/2021
Actual trial start date
Anticipated date of last follow up 16/02/2024
Actual Last follow-up date 19/12/2023
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 114
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
IAVI C102 PREVAIL12 Sponsor
IND 027351 US FDA
NCT04794218 clinicaltrials.gov
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group rVSVdeltaGLASVGPC Vaccine One dose (Day 1) Group 1: 2 X 10e4 Group 2: 2 X 10e5 Group 3: 2 X 10e6 Group 4: 2 X 10e7 Group 5: 2 X 10e5 Group 6: 2 X 10e6 Group 7: 2 X 10e7 One dose (Day 1) with 12 months safety follow-up Intramuscular injection 84
Control Group Diluent One dose (Day 1) One dose (Day 1) with 12 months safety follow-up Intramuscular injection 21 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults in good general health as assessed by medical history, physical examination, and laboratory tests who are ≥18 and <51 years of age, who 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. All women of childbearing potential (WOCBP) must commit to use an effective method of contraception. All sexually active participants must be willing to use male or female condoms for 4 months after receipt of IP. All potential participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study. Participants will not be eligible to participate in this study if they have confirmed HIV-1 or HIV-2 infection. 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. All WOCBP must not be pregnant or lactating. If participants have a bleeding disorder, any infectious diseases, or history of splenectomy, as well as abnormal laboratory parameters, they are also excluded. They are excluded if they have recently participated in another clinical trial of an investigational product (IP) or have a history of severe local or systemic reactogenicity to vaccines. 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. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 06/12/2021 National Research Ethics Board
Ethics Committee Address
Street address City Postal code Country
21st Street, Sinkor, JFK Compound, Monrovia, Liberia Monrovia 00000 Liberia
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) during a 14-day follow-up period after IP administration • Proportion of participants with Grade 2 or higher IP-related unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration • Proportion of participants with 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 AE of Special Interest (AESI) post-vaccination throughout the study period Day 15, Day 28
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 • Magnitude and duration of viral RNA in blood by PCR • Magnitude and duration of viral RNA in urine and saliva by PCR • Magnitude and duration of rVSV∆G-LASV-GPC vaccine shedding by culture Entire trial period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Brigham and Womens Hospital 221 Longwood Ave Brookline, MA 02115 Boston 02115 United States of America
George Washington University 2150 Pennsylvania Ave NW, 3rd Floor Washington, DC 20037 Washington DC 20037 United States of America
Redemption Hospital New Kru Town, Bushrod Island, Liberia, West Africa Monrovia Liberia
East West Medical Research Institute 1585 Kapiolani Blvd. Suite 1500, Honolulu, Hawaii 96814 Honolulu 96814 United States of America
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 New York, NY 10004 New York 10004 United States of America Non-profit scientific research organisation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Dagna Laufer dlaufer@iavi.org +12123287459 125 Broad Street, 9th Floor New York, NY 10004
City Postal code Country Position/Affiliation
New York 10004 United States of America Vice President and Head of Clinical Development
Role Name Email Phone Street address
Principal Investigator Mark Kieh mkieh@prevailcr.org +231770332591 Redemption Hospital, Borough of New Kru Town Bushord Isalnd Monrovia, Liberia
City Postal code Country Position/Affiliation
Monrovia Liberia PREVAIL Redemption Hospital
Role Name Email Phone Street address
Public Enquiries Gaudensia Mutua gmutua@iavi.org +254719043000 The Address, 11th Floor Muthangari Drive, Nairobi, Kenya
City Postal code Country Position/Affiliation
Nairobi Kenya IAVI Medical Director
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. Clinical Study Report The trial completion date will be recorded on this website as the date of database lock. 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