Characterisation of the Immune Responses of 2 Experimental Malaria Vaccines

April 24, 2017 updated by: GlaxoSmithKline

Adjuvant Justification Study of Candidate Malaria Vaccines (257049), Administered According to a 0, 1, 2 Months Schedule .

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Biological: 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).
Experimental: Group B
Biological: 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).
Experimental: Group C
Biological: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-CS antibody titers.
Time Frame: One month post Dose 3.
One month post Dose 3.

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms.
Time Frame: During the 7-day follow-up period following vaccination after each vaccine dose.
During the 7-day follow-up period following vaccination after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited symptoms.
Time Frame: During the 30-day follow-up period following vaccination after each vaccine dose.
During the 30-day follow-up period following vaccination after each vaccine dose.
Occurrence of serious adverse events.
Time Frame: Up until 1 month post dose 3.
Up until 1 month post dose 3.
Antibody responses to the P. falciparum circumsporozoite (CS) antigen.
Time Frame: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3.
At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3.
Antibody responses to HBs antigen.
Time Frame: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3
At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3
Frequency of CS and Hepatitis B surface agent (HBs)-specific CD4+ and CD8+ T cells expressing Th1 specific activation markers and cytokines.
Time Frame: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3
At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 26, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 13, 2007

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (Estimate)

March 5, 2007

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: 107731
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 107731
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 107731
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 107731
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 107731
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 107731
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe