Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS

Malaria Clinical Trial

Official title:

A Phase Ia Study to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 CS Administered Alone and With MVA CS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450280
• Other study ID #: VAC038
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2011
• Last updated: November 28, 2012
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• 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 the volunteer?s medical history with their General Practitioner

• Women only: Must practice continuous effective contraception for the duration of the study

• Agreement to refrain from blood donation during the course of the study and for 6 months after the end of their involvement in the study.

• Written informed consent

Exclusion Criteria:

• History of clinical P. falciparum malaria

• Travel to a malaria endemic region during the study period or within the preceding six months with a significant risk of malaria exposure.

• 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, breast feeding 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 post vaccination.

• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).

• 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 5 years preceding enrolment.

• Seropositive for hepatitis B surface antigen (HBsAg).

• Seropositive for hepatitis C virus (antibodies to HCV).

• Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination.

• 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 the 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:
• ChAd63 CS
ChAd63 CS 5x10^9 vp intra-muscularly Day 0
• ChAd63 CS, MVA CS
ChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
• ChAd63 CS
ChAd63 CS 5x10^10 vp intra-muscularly Day 0
• ChAd63, MVA CS
ChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56

Locations

Country	Name	City	State
Ireland	Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment of new candidate malaria vaccines ChAd63 CS	To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events.	Participants will be followed for the duration of the study, an expected average of 12 months	Yes
Secondary	Assessment of immune response induced by vaccination	To assess the humoral and cellular immune responses generated by ChAd63 CS when administered to healthy volunteers alone and with MVA CS 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 12 months	No