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.: PACTR201402000749217 Date of Approval: 22/01/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Malaria vectored vaccines and EPI co-administration trial (VAC 058)
Official scientific title A Phase I study to assess the safety and immunogenicity of ChAd63 ME-TRAP ¿ MVA ME-TRAP heterologous prime-boost vaccination co-administered with EPI vaccines in Gambian infants
Brief summary describing the background and objectives of the trial Plasmodium falciparum malaria remains a major public health problem causing approximately 219 million cases worldwide and 660,000 deaths occurring predominantly in under-five children in Africa. The development of an effective malaria vaccine is of high priority in the context of coordinated efforts to reduce the burden of malaria and it is considered crucial for global eradication of malaria. We recently evaluated malaria vectored vaccine candidates, ChAd63 ME-TRAP and MVA.ME-TRAP, in Gambian adults, children and infants with satisfactory safety and promising immunogenicity profiles. As the vaccines are planned to be given to younger infants when licensed, it is important to assess whether these candidate vaccines cause interference when co-administered with routine Expanded Programme on Immunisation (EPI) vaccines. This will guide selection of optimal vaccination schedule before planning large efficacy trials. We propose a phase I trial of safety and immunogenicity of ChAd63 ME-TRAP and MVA.ME-TRAP when co-administered with EPI vaccines in a small group of healthy infants aged 16 weeks, 8 weeks and 1 week. We will assess safety by post-vaccination clinical evaluations, interference by antibody responses to Hepatitis B, DTP, Hib and pneumococcal vaccines at 24 weeks, immunogenicity by ELISPOT assays and intra-cellular cytokine staining by flow cytometry.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VAC058
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 03/03/2014
Actual trial start date 17/03/2014
Anticipated date of last follow up 15/04/2015
Actual Last follow-up date 22/06/2015
Anticipated target sample size (number of participants) 65
Actual target sample size (number of participants) 65
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
SCC1367 GAMBIA GOVERNMENT/MEDICAL RESEARCH COUNCIL JOINT ETHICS COMMITTEE
7-14 OXFORD TROPICAL RESEARCH ETHICS COMMITTEE
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 randomisation using a randomisation table created by a computer software progran Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ChAd63 ME-TRAP 5 x 10^10vp ChAd63-ME-TRAP is administered intramuscularly at Day 0 (at enrolment) Prime-boost heterologous malaria vectored vaccines: 15 healthy infants aged 16 wks at enrollment; 15 healthy infants aged 8 wks at enrollment; 15 health infants aged 1wk at enrollment 45 Uncontrolled
Control Group Control Control treatment: 5 healthy infants aged 16wks at enrollment; 5 healthy infants aged 8wks at enrollment; 10 healthy infants aged 1 wk at enrollment 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Group 1: 15 healthy infants aged 16 weeks at the time of enrolment with signed consent obtained from parents. Group 2: 15 healthy infants aged 8 weeks at the time of enrolment with signed consent obtained from parents. Group 3: 15 healthy infants aged 1 week at the time of enrolment with signed consent obtained from parents. Group 4 (control): 20 healthy infants aged 16, 8 and 1 weeks at the time of enrolment with signed consent obtained from parents Groups 1 and 2: Receipt of all EPI vaccines according to schedule defined as follows: BCG, and first dose of OPV and Hepatitis B vaccine within 2 weeks of birth; Penta, pneumococcal vaccine, OPV, rotavirus vaccine for Group 1 at 8 weeks +/- 2 weeks. Birth weight less than 2.5kg Significant antenatal, perinatal or early postnatal complications as judged by the PI or other delegated individual Any signs of acute illness as judged by the PI or other delegated individual Axillary temperature of greater than 37.5 °C Clinically significant congenital abnormalities as judged by the PI or other delegated individual ¿ Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual. Weight for age z-scores below 2 standard deviations of normal for age History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone. History of splenectomy Haemoglobin less than 10 g/dL at > 4 weeks of age or less than 13.0 g/dl at < 4 weeks of age. White cell count <5.0 x 10^9/L Serum Creatinine concentration greater than 60 micromol/L, Serum ALT concentration greater than 45 U/L, Clinically significant jaundice Any other clinically significant laboratory abnormality as judged by the PI or other delegated individual Blood transfusion within one month of enrolment. History of vaccination with previous experimental malaria vaccines. Administration of any immunoglobulin less than two weeks before vaccination with the IMPs Current participation in another clinical trial, or within 12 weeks of this study. Any other finding which in the opinion of the PI or other delegated individual would increase the risk of an adverse outcome from participation in the trial. Likelihood of travel away from the study area Maternal HIV infection (a negative maternal HIV test will be required prior to study enrolment) Positive malaria antigen test at screening 1 Week(s) 16 Week(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 07/01/2014 GAMBIA GOVERNMENT/MEDICAL RESEARCH COUNCIL JOINT ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
ATLANTIC BOULEVARD, FAJARA BANUL 0220 Gambia
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 18/02/2014 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Univ Oxford, Joint Research Office, Block 60, Churchill Hospital Oxford OX3 7LE United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All solicited and unsolicited local and systemic adverse events (including laboratory abnormalities considered adverse events) and the assessment of their causal relationships to the study vaccines Three consecutive days after vaccination i.e Days 0 and 56, Days 7, 21, 112, 168, 224 and 252
Secondary Outcome Measures of immunogenicity of ChAD63 ME-TRAP/MVA ME-TRAP prime boost immunisation where practibable to include: 1) ex vivo ELISPOT responses to overlapping pools of ME-TRAP peptides; 2) ICS and floe cytometry; 3) Antibodies to TRAP by ELISA; 4) Anti-vector immune responses; 6) Exploratory immunology including RNA analysis Three consecutive days after vaccination i.e. Days 0 and 56, Days 7, 21, 112, 168, 224 and 252
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Council Unit, Fajara, The Gambia (MRC Sukuta field site) Atlantic Boulevard, Fajara Banjul 0220 Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIAL PARTNERSHIP 334 LAAN VAN NIEUW OOST INDIE THE HAGUE 2593 CE Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor THE JENNER INSTITUTE, UNIVERSITY OF OXFORD CHURCHILL HOSPITAL, OLD ROAD OXFORD OX37LJ United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
UNIVERSITE CHEIKH ANTA DIOP BP 5005 DAKAR-FANN DAKAR BP 5005 Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhammed Afolabi mafolabi@mrc.gm +220-7059861 ATLANTIC BOULEVARD, FAJARA, P.O. BOX 273
City Postal code Country Position/Affiliation
BANJUL 0220 Gambia
Role Name Email Phone Street address
Public Enquiries Egeruan Babatunde Imoukhuede egeruan.imoukhuede@ndm.ox.ac.uk +44 186 585 7568 The Jenner Institute, Centre for Vaccinology and Tropical Medicine, Churchill's Hopital
City Postal code Country Position/Affiliation
Oxford OX3 7LJ United Kingdom Clinical Project Manager
Role Name Email Phone Street address
Scientific Enquiries Muhammed Afolabi mafolabi@mrc.gm +220 705 9861 Vaccinolgy Theme, Medical Research Council Unit, Atlantic Road; PO Box 273
City Postal code Country Position/Affiliation
Fajara Gambia
REPORTING
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