Safety and Immunogenicity of Novel Vaccination Schedules With Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP

Malaria Clinical Trial

Official title:

A Phase I Study to Assess the Safety and Immunogenicity of Novel Schedules for Vaccination With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364883
• Other study ID #: VAC043
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2011
• Last updated: July 26, 2013
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy adults aged 18 to 50 years

• Able and willing (in the Investigator's opinion) to comply with all study requirements

• Willing to allow the investigators to discuss their medical history with their General Practitioner

• For female volunteers, willingness to practice continuous effective contraception during the study

• Agreement to refrain from blood donation during the course of the study

• Written informed consent

Exclusion Criteria:

• Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period

• Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data

• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate

• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)

• Pregnancy, lactation, or intention to become pregnant during the study

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon History of clinically significant contact dermatitis

• Any history of anaphylaxis in relation to vaccination

• Any history of malaria Travel to a malaria endemic region during the study period or within the six months preceding enrolment in the study

• History of serious psychiatric condition that may affect participation in the study

• Any other serious chronic illness requiring hospital specialist supervision -Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week

• Suspected or known injecting drug abuse in the five years preceding enrolment -Seropositive for hepatitis B surface antigen (HBsAg)

• Seropositive for hepatitis C virus (antibodies to HCV)

• Any relevant history of cancer (excludes basal cell carcinoma of the skin and cervical carcinoma in situ)

• Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis

• Any other significant 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 study data

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Biological:
• Vaccination Schedule One
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
• Vaccination Schedule Two
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
• Vaccination Schedule Three
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
• Vaccination Schedule Four
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
• Vaccination Schedule Five
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
• Vaccination Schedule Six
Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
• Vaccination Schedule Seven
AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24

Locations

Country	Name	City	State
United Kingdom	Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine Safety	To assess the safety of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7	Participants will be followed for the duration of the study, an expected average of 21 months	Yes
Secondary	Vaccine immunogenicity	To assess the immunogenicity of vaccination of healthy adults with AdCh63 ME-TRAP and MVA ME-TRAP according to vaccination schedules 1 to 7	Participants will be followed for the duration of the study, an expected average of 21months	No