Characterisation of the Immune Responses of 2 Experimental Malaria Vaccines

NCT ID: NCT00443131

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-26
• Study Completion Date: 2007-07-13

Brief Summary

In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and characterise how the vaccine exactly works on the immune system by comparing it to a control (without adjuvant). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A

Group Type: EXPERIMENTAL

GSK Malaria vaccine 257049

Intervention Type: BIOLOGICAL

Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).

Group B

Group Type: EXPERIMENTAL

GSK Malaria vaccine 257049

Intervention Type: BIOLOGICAL

Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).

Group C

Group Type: EXPERIMENTAL

GSK Malaria vaccine 257049

Intervention Type: BIOLOGICAL

Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).

Interventions

GSK Malaria vaccine 257049

Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Have clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential at screening.
• Be seronegative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibodies, HBsAg and hepatitis C virus (HCV) antibodies.
• Have anti HBs titre ≥ 10mIU/ml at screening.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Any history of clinical malaria.
• Known exposure to malaria parasites within the previous 12 months.
• Planned travel to a malaria endemic region during the study period.
• History of allergic reactions or anaphylaxis to previous immunizations.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness(es).
• Acute disease at the time of enrolment.
• History of any neurologic disorders or seizures.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• History of previous exposure to experimental products containing any component of the vaccines used in this study.
• Pregnant or lactating female.
• History of chronic alcohol consumption and/or drug abuse.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ghent, , Belgium

Countries

Belgium

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

107731

Identifier Type: -

Identifier Source: org_study_id