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A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

Primary Purpose

Malaria

Status

Completed

Phase

Phase 1

Locations

Burkina Faso

Study Type

Interventional

Intervention

ChAd63 ME-TRAP and MVA ME-TRAP

Rabies vaccine

About this trial

This is an interventional prevention trial for Malaria

Eligibility Criteria

5 Months - 17 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.)

Sites / Locations

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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ChAd63 ME-TRAP and MVA ME-TRAP

Rabies vaccine

Arm Description

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

2 x 2.5IU Verorab

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of Protective efficacy against clinical malaria

To assess the protective efficacy against clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 12 and 24* months after the last vaccination.

Efficacy against asymptomatic P. falciparum infection

To assess the protective efficacy against asymptomatic P. falciparum infection of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, 6, 12 and 24* months after the last vaccination

Efficacy against secondary case definitions of clinical malaria

To assess the protective efficacy against secondary case definitions of clinical malaria of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 6, 12 and 24 months after the last vaccination

Safety Objective

To assess the safety and reactogenicity of ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area, for 6, 12 and 24 months after the last vaccination.

Immunogenicity Objectives

To assess the immunogenicity of ChAd63 ME-TRAP / MVA ME- TRAP heterologous prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area. To explore the immunologic correlates of protective efficacy of ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation, in 5-17 month old infants and children living in a malaria-endemic area.

Full Information

NCT ID

NCT01635647

First Posted

July 3, 2012

Last Updated

February 12, 2016

Sponsor

University of Oxford

Collaborators

European and Developing Countries Clinical Trials Partnership (EDCTP)

1. Study Identification

Unique Protocol Identification Number

NCT01635647

Brief Title

A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

Official Title

A Phase 1/2b Double Blind Randomised Controlled Trial of the Efficacy, Safety and Immunogenicity of Heterologous Prime-boost Immunisation With the Candidate Malaria Vaccines ChAd63 ME-TRAP and MVA ME-TRAP in 5-17 Month Old Burkinabe Infants and Children

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

Collaborators

European and Developing Countries Clinical Trials Partnership (EDCTP)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

730 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ChAd63 ME-TRAP and MVA ME-TRAP

Arm Type

Active Comparator

Arm Description

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

Arm Title

Rabies vaccine

Arm Type

Placebo Comparator

Arm Description

2 x 2.5IU Verorab

Intervention Type

Biological

Intervention Name(s)

ChAd63 ME-TRAP and MVA ME-TRAP

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Rabies vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Duration of Protective efficacy against clinical malaria

Description

Time Frame

12 and 24 months

Title

Efficacy against asymptomatic P. falciparum infection

Description

Time Frame

6, 12 and 24 months

Title

Efficacy against secondary case definitions of clinical malaria

Description

Time Frame

6, 12 and 24 months

Title

Safety Objective

Description

Time Frame

6, 12 and 24 months

Title

Immunogenicity Objectives

Description

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Months

Maximum Age & Unit of Time

17 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.)

Facility Information:

Facility Name

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)

City

Ouagadougou

ZIP/Postal Code

BP 2208

Country

Burkina Faso

12. IPD Sharing Statement

Citations:

PubMed Identifier

30540808

Citation

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.

Results Reference

derived

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A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

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