Nigeria Clinical Trial Registry
Federal Ministry of Health
Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: info@nhrec.ne

Trial No: 0
Date registered: 2023-04-11
Trial Status: Pending
TRIAL DESCRIPTION
Public title A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children
Official scientific title A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children
Brief summary describing the background
and objectives of the trial
Lassa fever (LF) is a severe viral disease endemic to West African countries estimated to cause up to 500 000 LF cases and 10 000 deaths annually. The main objective is to evaluate the safety and tolerability of rVSVĪ”G-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children
Type of trial Prevention
Acronym (If the trial has an acronym then please provide) A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children
Disease(s) or condition(s) being studied Lassa
Purpose of the trial
Anticipated trial start date 2023-06-15
Actual trial start date 2023-07-05
Anticipated date of last follow up 2023-06-26
Actual date of last follow up 2025-10-31
Anticipated target sample size (number of participants) 310   
Actual target sample size (number of participants) 310   
Recruitment status Not yet recruiting
No Secondary ID Issuing authority/Trial register
11 1

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
Single group Non-randomised 1 sealed opaque envelopes. 1 Participants,Outcome Assessors,1

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group dgrviwoa 1 1 1 Active
Control group nbmxyaxi 1 1 1 Active
Experimental group opicgrhh 1 1 1 Placebo
Control group oeqonksh 1 1 1 Placebo
Experimental group bkvtlsmy 1 1 1 Historical
Control group lrjwbdsa 1 1 1 Uncontrolled
Experimental group djkfgswy 1 1 1 Uncontrolled
Control group fwedfgae 1 1 1 Historical
Experimental group ncbfnmyn 1 1 1 Dose comparison
Control group uoqkquom 1 1 1 Dose comparison

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1 1 1 1 1

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
0000-00-00 0000-00-00 mciacekw
Ethics Committee Address
Street address City Postal code Country
3137 Laguna Street San Francisco 94102 Afghanistan
0000-00-00 0000-00-00 oohbxeng
Ethics Committee Address
Street address City Postal code Country
3137 Laguna Street San Francisco 94102 Afghanistan

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 1 1

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
1 3137 Laguna Street San Francisco 94102 Afghanistan
1 3137 Laguna Street San Francisco 94102 Albania
1 3137 Laguna Street San Francisco 94102 Algeria

FUNDING SOURCES
Name of source Street address City Postal code Country

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor

COLLABORATORS
Name Street address City Postal code Country
Dr Olufemi Omoz-oarhe Garki Hospital Abuja Abuja 900103 Nigeria
Dr Fidelis Bakut Garki Hospital Abuja Abuja 900103 Nigeria
Professor Joseph Otubu Garki Hospital Abuja Abuja 900103 Nigeria

CONTACT PEOPLE
Role Name Email Phone Fax