AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area

Safety and Immunogenicity of Heterologous Prime-boost Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Infants in a Malaria- Endemic Area

Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the Gambia. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Biological: AdCh63 ME-TRAP, MVA ME-TRAP; Biological: AdCH63 ME-TRAP, MVA ME-TRAP

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Gambia
  • Banjul, Gambia
    • Medical Research Council Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents.

Exclusion Criteria:

• 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.
• Severe malnutrition.
• 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 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
• Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator
• Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
• Blood transfusion within one month of enrollment.
• History of vaccination with previous experimental malaria vaccines. -Administration of any other vaccine or 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 investigators would increase the risk of an adverse outcome from participation in the trial.
• Likelihood of travel away from the study area
• Maternal HIV infection Positive malaria antigen test at screening
• Failure to have received, prior to enrollment, the routine EPI vaccinations due according to the Gambian EPI schedule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP	Biological: AdCh63 ME-TRAP, MVA ME-TRAP; 1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
Experimental: Group B; 5 to 12 months old infants; AdCh63 ME-TRAP, MVA ME-TRAP	Biological: AdCH63 ME-TRAP, MVA ME-TRAP; 5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
No Intervention: Group C; 5 to 12 months old infants; no vaccination
Experimental: Group D; 10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP	Biological: AdCh63 ME-TRAP, MVA ME-TRAP; 1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
Experimental: Group E; 10 week old babies; AdCh63 ME-TRAP, MVA ME-TRAP	Biological: AdCH63 ME-TRAP, MVA ME-TRAP; 5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
No Intervention: Group F; 10 week old babies; no vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP	To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by recording local and systemic solicited and unsolicited adverse events	Participants will be followed for the duration of the study, an expected average of 16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP	To assess the immunogenicity of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by assessing induced antibody and T cell response to the vaccine insert	Participants will be followed for the duration of the study, an expected average of 16 months

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP)
• Investigators: Principal Investigator: Kalifa Bojang, Medical Research Council PO Box 273, Banjul The Gambia

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 12, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Immune response
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: VAC042