NCT01635647

Brief Summary

Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
730

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

July 3, 2012

Last Update Submit

February 12, 2016

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • Time to first episode of malaria meeting the primary case definition of clinical malaria episode

    6 months

Secondary Outcomes (5)

  • Duration of Protective efficacy against clinical malaria

    12 and 24 months

  • Efficacy against asymptomatic P. falciparum infection

    6, 12 and 24 months

  • Efficacy against secondary case definitions of clinical malaria

    6, 12 and 24 months

  • Safety Objective

    6, 12 and 24 months

  • Immunogenicity Objectives

    24 months

Study Arms (2)

ChAd63 ME-TRAP and MVA ME-TRAP

ACTIVE COMPARATOR

ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation

Biological: ChAd63 ME-TRAP and MVA ME-TRAP

Rabies vaccine

PLACEBO COMPARATOR

2 x 2.5IU Verorab

Biological: Rabies vaccine

Interventions

ChAd63 ME-TRAP and MVA ME-TRAPBIOLOGICAL

ChAd63 ME-TRAP: 5 x 10\^10vp MVA ME-TRAP: 1 x 10\^8 pfu heterologous prime-boost immunisation

ChAd63 ME-TRAP and MVA ME-TRAP
Rabies vaccineBIOLOGICAL

Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab

Rabies vaccine

Eligibility Criteria

Age5 Months - 17 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infant/child aged 5-17 months at the time of first study vaccination
  • Informed consent of parent/guardian
  • Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up

You may not qualify if:

  • Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
  • Weight-for-age Z score of less than -3 or other clinical signs of malnutrition
  • History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone.
  • 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 µmol/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 enrolment
  • Previous vaccination with experimental malaria vaccines.
  • Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine.
  • 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 or result in incomplete or poor quality data
  • Known maternal HIV infection (No testing will be done by the study team)
  • Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and 1. Centre National de Recherche et de Formation sur le Paludisme (CNRFP)/ Unité de Recherche Clinique de Banfora (URC-B)

Ouagadougou, BP 2208, Burkina Faso

Location

Related Publications (2)

  • Morter R, Tiono AB, Nebie I, Hague O, Ouedraogo A, Diarra A, Viebig NK, Hill AVS, Ewer KJ, Sirima SB. Impact of exposure to malaria and nutritional status on responses to the experimental malaria vaccine ChAd63 MVA ME-TRAP in 5-17 month-old children in Burkina Faso. Front Immunol. 2022 Dec 2;13:1058227. doi: 10.3389/fimmu.2022.1058227. eCollection 2022.

    PMID: 36532031DERIVED

  • Tiono AB, Nebie I, Anagnostou N, Coulibaly AS, Bowyer G, Lam E, Bougouma EC, Ouedraogo A, Yaro JBB, Barry A, Roberts R, Rampling T, Bliss C, Hodgson S, Lawrie A, Ouedraogo A, Imoukhuede EB, Ewer KJ, Viebig NK, Diarra A, Leroy O, Bejon P, Hill AVS, Sirima SB. First field efficacy trial of the ChAd63 MVA ME-TRAP vectored malaria vaccine candidate in 5-17 months old infants and children. PLoS One. 2018 Dec 12;13(12):e0208328. doi: 10.1371/journal.pone.0208328. eCollection 2018.

    PMID: 30540808DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 9, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations

BU(1)