Back to resultsEfficacy of Candidate Malaria Vaccines in Senegalese Adults
Primary Purpose
Malaria
Status
Completed
Phase
Phase 2
Locations
Senegal
Study Type
Interventional
Intervention
ChAd63 ME-TRAP and MVA ME-TRAP
Rabies vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Malaria
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 HDCRV,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
- University Cheikh Anta Diop (UCAD)
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
Vaccine Efficacy
We will compare active and control vaccination for time to first episode of P.falciparum infection, defined as 2 or more consecutive blood samples confirmed 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. 25 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 All solicited and unsolicited local and systemic vaccine- linked adverse events (AEs) including clinically significant laboratory abnormalities.
Safety
All solicited and unsolicited local and systemic vaccine- linked adverse events (AEs) including clinically significant laboratory abnormalities.
Full Information
NCT ID
NCT01658696
First Posted
July 31, 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
NCT01658696
Brief Title
Efficacy of Candidate Malaria Vaccines in Senegalese Adults
Official Title
Efficacy Study of ChAd63-MVA 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
August 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (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 with previous vector platforms.
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 Senegal. 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
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (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: 2 x 10^8 pfu heterologous prime-boost immunisation
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
We will compare active and control vaccination for time to first episode of P.falciparum infection, defined as 2 or more consecutive blood samples confirmed positive by PCR, for P.falciparum.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Vaccine immunogenicity
Description
Measures of immunogenicity will include:
Ex vivo ELISPOT responses to overlapping pools of ME - TRAP peptides. 25 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 All solicited and unsolicited local and systemic vaccine- linked adverse events (AEs) including clinically significant laboratory abnormalities.
Time Frame
24 weeks
Title
Safety
Description
All solicited and unsolicited local and systemic vaccine- linked adverse events (AEs) including clinically significant laboratory abnormalities.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Tertiary Endpoint - Metaanalysis of Vaccine Efficacy
Description
We will compare combined active vaccination from VAC046 and VAC047, with combined control vaccination from VAC046 and VAC047, for time to first episode of P.falciparum infection, defined as 2 or more consecutive blood samples confirmed positive by PCR for P.falciparum.
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
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 HDCRV,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
University Cheikh Anta Diop (UCAD)
City
Dakar
ZIP/Postal Code
BP 5005
Country
Senegal
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Candidate Malaria Vaccines in Senegalese Adults
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