AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area

Malaria Clinical Trial

Official title:

Safety and Immunogenicity of Heterologous Prime-boost Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Infants in a Malaria- Endemic Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450293
• Other study ID #: VAC042
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2011
• Last updated: December 11, 2013
• Start date: October 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2013
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gambia: MRC Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the Gambia. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Weeks to 12 Months

Eligibility

Inclusion Criteria:

• Healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents.

Exclusion Criteria:

• Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.

• Severe malnutrition.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.

• History of splenectomy 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 mol/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 enrollment.

• History of vaccination with previous experimental malaria vaccines. -Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs 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.

• Likelihood of travel away from the study area

• Maternal HIV infection Positive malaria antigen test at screening

• Failure to have received, prior to enrollment, the routine EPI vaccinations due according to the Gambian EPI schedule.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Biological:
• AdCh63 ME-TRAP, MVA ME-TRAP
1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
• AdCH63 ME-TRAP, MVA ME-TRAP
5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.

Locations

Country	Name	City	State
Gambia	Medical Research Council Laboratories	Banjul

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	European and Developing Countries Clinical Trials Partnership (EDCTP)

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP	To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by recording local and systemic solicited and unsolicited adverse events	Participants will be followed for the duration of the study, an expected average of 16 months	Yes
Secondary	Immunogenicity of heterologous prime-boost vaccination with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP	To assess the immunogenicity of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP by assessing induced antibody and T cell response to the vaccine insert	Participants will be followed for the duration of the study, an expected average of 16 months	No