Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children

Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years

GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Gabon
  • Lambaréné, Gabon
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) at the time of first vaccination.
• Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits)

Exclusion criteria:

• Acute disease at the time of enrolment.
• Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
• Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of range.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
• Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Previous participation in any other malaria vaccine trial.
• Simultaneous participation in any other clinical trial.
• Same sex twin.
• History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group B	Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049; 3-dose intramuscular injection, 2 different formulations
ACTIVE_COMPARATOR: Group A	Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049; 3-dose intramuscular injection, 2 different formulations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of SAEs.	From the time of first vaccination until one month post Dose 3
Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS).	One month post Dose 3.

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of solicited general and local reactions.	Over a 7-day follow-up period after each vaccination.
Occurrence of unsolicited symptoms.	After each vaccination over a 30-day follow-up
Anti-CS antibody titers.	Prior to vaccination, one month post Dose 2
Anti-Hepatitis B surface agent (anti-HBs) antibody titers.	Prior to vaccination, one month post Dose 2 and one month post Dose 3.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Agnandji ST, Fendel R, Mestre M, Janssens M, Vekemans J, Held J, Gnansounou F, Haertle S, von Glasenapp I, Oyakhirome S, Mewono L, Moris P, Lievens M, Demoitie MA, Dubois PM, Villafana T, Jongert E, Olivier A, Cohen J, Esen M, Kremsner PG, Lell B, Mordmuller B. Induction of Plasmodium falciparum-specific CD4+ T cells and memory B cells in Gabonese children vaccinated with RTS,S/AS01(E) and RTS,S/AS02(D). PLoS One. 2011 Apr 11;6(4):e18559. doi: 10.1371/journal.pone.0018559.
• Lell B, Agnandji S, von Glasenapp I, Haertle S, Oyakhiromen S, Issifou S, Vekemans J, Leach A, Lievens M, Dubois MC, Demoitie MA, Carter T, Villafana T, Ballou WR, Cohen J, Kremsner PG. A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon. PLoS One. 2009 Oct 27;4(10):e7611. doi: 10.1371/journal.pone.0007611.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: April 7, 2006
• Primary Completion (ACTUAL): September 15, 2006
• Study Completion (ACTUAL): August 22, 2007

Study Registration Dates

• First Submitted: February 16, 2006
• First Submitted That Met QC Criteria: March 23, 2006
• First Posted (ESTIMATE): March 27, 2006

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: Malaria; Parasitic Diseases; Malaria, Falciparum; Coccidiosis
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: 105874

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. Study Protocol
   Information identifier: 105874
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 105874
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 105874
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 105874
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 105874
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: 105874
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register