Characterisation of the Immune Responses of 2 Experimental Malaria Vaccines

NCT00443131 | Completed Phase 2

• 1 other identifier: 107731
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Adjuvant; Malaria; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Anti-CS antibody titers.

  One month post Dose 3.

Secondary Outcomes (6)

• Occurrence, intensity and relationship to vaccination of solicited local and general symptoms.

  During the 7-day follow-up period following vaccination after each vaccine dose.

• Occurrence, intensity and relationship to vaccination of unsolicited symptoms.

  During the 30-day follow-up period following vaccination after each vaccine dose.

• Occurrence of serious adverse events.

  Up until 1 month post dose 3.

• Antibody responses to the P. falciparum circumsporozoite (CS) antigen.

  At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3.

• Antibody responses to HBs antigen.

  At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3

Study Arms (3)

Group A

EXPERIMENTAL

Biological: GSK Malaria vaccine 257049

Group B

EXPERIMENTAL

Biological: GSK Malaria vaccine 257049

Group C

EXPERIMENTAL

Biological: GSK Malaria vaccine 257049

Interventions

GSK Malaria vaccine 257049 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 A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: March 26, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 13, 2007
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)