Back to results

Efficacy of Malaria Vaccines in Kenyan Adults

Primary Purpose

Malaria

Status

Completed

Phase

Phase 2

Locations

Kenya

Study Type

Interventional

Intervention

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

Rabies vaccine

About this trial

This is an interventional prevention trial for Malaria

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Consenting adult males aged 18 - 50 years in good health.
Will remain resident in the study area for the study duration.
Able and willing (in the Investigator's opinion) to comply with all study requirements
Informed Consent

Exclusion Criteria:

Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
Hypersensitivity to Verorab, the trial vaccines or the antimalarial used.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, kathon, neomycin
History of splenectomy.
Haemoglobin less than 10.0 g/dl
Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels).
Blood transfusion within the month preceding enrolment.
History of vaccination with previous experimental malaria vaccines or other vaccines likely to impact on findings of study (e.g. other MVA or adenovirus vectored vaccines)
Administration of any other vaccine or immunoglobulin within 2 weeks before vaccination.
HIV or Hepatitis B surface antigen seropositivity.
Current participation in another clinical trial or recent participation 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

Sites / Locations

KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active 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

Vaccine Efficacy

The first episode of P.falciparum infection positive by PCR, for P.falciparum.

Secondary Outcome Measures

Vaccine immunogenicity

Measures of immunogenicity will include: Ex vivo ELISPOT responses to overlapping pools of ME - TRAP peptides. Cultured ELISPOT responses to overlapping pools of ME - TRAP peptides. ICS by flow cytometry for cell mediated immune responses ELISA for antibodies to malaria antigens

Reactogenicity

All solicited and unsolicited local and systemic vaccine- linked adverse events (AEs) including clinically significant laboratory abnormalities.

Full Information

NCT ID

NCT01666925

First Posted

August 14, 2012

Last Updated

December 11, 2013

Sponsor

University of Oxford

Collaborators

European and Developing Countries Clinical Trials Partnership (EDCTP)

1. Study Identification

Unique Protocol Identification Number

NCT01666925

Brief Title

Efficacy of Malaria Vaccines in Kenyan Adults

Official Title

Efficacy Study of ChAd63MVA ME-TRAP Prime-boost Vaccination Against Plasmodium Falciparum Infection.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (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

Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials become more widely available. However, transmission still persists and it appears that additional control measures are required. The leading malaria vaccine candidate in development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the field. This partial protection might be enhanced by combination with other components. The other vaccination approach that has produced repeatable efficacy in humans is the use of viral vectors to induce T cell responses. Previous attempts with this vaccine approach have been effective in challenge studies in Oxford, but ineffective in the field, probably because of reduced immunogenicity. Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with thrombospondin- related adhesion protein (ME-TRAP). The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and partial protection in 5 out of 14 volunteers in challenge studies. The investigators propose a Phase 2b study of 120 healthy adult men in Kenya. The investigators will assess the efficacy and further evaluate the immunogenicity and safety profile of the vaccine regimen. The investigators also intend to assess the correlates of efficacy and natural immunity.

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 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ChAd63 ME-TRAP and MVA ME-TRAP

Arm Type

Experimental

Arm Description

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

Arm Title

Rabies vaccine

Arm Type

Active Comparator

Arm Description

2 x 2.5IU Verorab

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 2 x 10^8 pfu

Intervention Type

Biological

Intervention Name(s)

Rabies vaccine

Other Intervention Name(s)

Verorab

Intervention Description

2 x 2.5IU Verorab

Primary Outcome Measure Information:

Title

Vaccine Efficacy

Description

The first episode of P.falciparum infection positive by PCR, for P.falciparum.

Time Frame

18 weeks

Secondary Outcome Measure Information:

Title

Vaccine immunogenicity

Description

Time Frame

24 weeks

Title

Reactogenicity

Description

All solicited and unsolicited local and systemic vaccine- linked adverse events (AEs) including clinically significant laboratory abnormalities.

Time Frame

24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Consenting adult males aged 18 - 50 years in good health. Will remain resident in the study area for the study duration. Able and willing (in the Investigator's opinion) to comply with all study requirements Informed Consent Exclusion Criteria: Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data Hypersensitivity to Verorab, the trial vaccines or the antimalarial used. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, kathon, neomycin History of splenectomy. Haemoglobin less than 10.0 g/dl Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels). Blood transfusion within the month preceding enrolment. History of vaccination with previous experimental malaria vaccines or other vaccines likely to impact on findings of study (e.g. other MVA or adenovirus vectored vaccines) Administration of any other vaccine or immunoglobulin within 2 weeks before vaccination. HIV or Hepatitis B surface antigen seropositivity. Current participation in another clinical trial or recent participation 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

Facility Information:

Facility Name

KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast

City

Kilifi

ZIP/Postal Code

PO Box 230, 80108

Country

Kenya

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Malaria Vaccines in Kenyan Adults

We'll reach out to this number within 24 hrs