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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Oxford

ClinicalTrials.gov Identifier:

NCT01450280

First received: October 3, 2011

Last updated: November 28, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2011

Last Updated Date

November 28, 2012

Start Date ^ICMJE

December 2011

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety assessment of new candidate malaria vaccines ChAd63 CS [ Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Safety assessment of new candidate malaria vaccines ChAd63 CS [ Time Frame: Participants will be followed for the duration of the study, an expected average of 18 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01450280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of immune response induced by vaccination [ Time Frame: Participants will be followed for the duration of the study, an expected average of 12 months ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

Assessment of immune response induced by vaccination [ Time Frame: Participants will be followed for the duration of the study, an expected average of 18 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Malaria

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Group 1A
AdCh63 CS 5x10^9 vp

Intervention: Biological: ChAd63 CS
Experimental: Group 1B
ChAd63 CS 5x10^9 vp Day 0; MVA CS 2x10^8 pfu Day 56

Intervention: Biological: ChAd63 CS, MVA CS
Experimental: Group 2A
AdCh63 CS 5 x 10^10 vp

Intervention: Biological: ChAd63 CS
Experimental: Group 2B
ChAd63 CS 5x10^10 vp Day 0; MVA CS 2x10^8 pfu Day 56

Intervention: Biological: ChAd63, MVA CS

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Ireland

Administrative Information

NCT Number ^ICMJE

NCT01450280

Other Study ID Numbers ^ICMJE

VAC038

Has Data Monitoring Committee

Yes

Responsible Party

University of Oxford

Study Sponsor ^ICMJE

University of Oxford

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sam McConkey

Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)

Information Provided By

University of Oxford

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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