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Efficacy of Malaria Vaccines in Kenyan Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01666925
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : December 12, 2013
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Malaria Biological: ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation Biological: Rabies vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Efficacy Study of ChAd63MVA ME-TRAP Prime-boost Vaccination Against Plasmodium Falciparum Infection.
Study Start Date : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: ChAd63 ME-TRAP and MVA ME-TRAP
ChAd63 ME-TRAP / MVA ME-TRAP heterologous prime-boost immunisation
Biological: ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation
ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 2 x 10^8 pfu

Active Comparator: Rabies vaccine
2 x 2.5IU Verorab
Biological: Rabies vaccine
2 x 2.5IU Verorab
Other Name: Verorab

Primary Outcome Measures :
  1. Vaccine Efficacy [ Time Frame: 18 weeks ]
    The first episode of P.falciparum infection positive by PCR, for P.falciparum.

Secondary Outcome Measures :
  1. Vaccine immunogenicity [ Time Frame: 24 weeks ]

    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

  2. Reactogenicity [ Time Frame: 24 weeks ]
    All solicited and unsolicited local and systemic vaccine- linked adverse events (AEs) including clinically significant laboratory abnormalities.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01666925

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KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
Kilifi, Kenya, PO Box 230, 80108
Sponsors and Collaborators
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP)
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Responsible Party: University of Oxford Identifier: NCT01666925    
Other Study ID Numbers: VAC046
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Immunologic Factors
Physiological Effects of Drugs