Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children. - Full Text View

Purpose

This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Malaria	Biological: GSK malaria vaccine 257049 Vaccine Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Bio's Candidate Vaccine RTS,S/AS01, Administered According to a 0,1,2-mths Schedule in Children Aged 5 to 17 Mths Living in Tanzania & Kenya

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Rabies Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

First case of malaria meeting the primary case definition [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

First case of malaria meeting the secondary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months ] [ Designated as safety issue: No ]
Multiple events of malaria meeting the primary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months. ] [ Designated as safety issue: No ]
Multiple events of malaria meeting the secondary case definition. [ Time Frame: Over a period starting 14 days after Dose 3 and extending for 4 months. ] [ Designated as safety issue: No ]
Parasite prevalence and density [ Time Frame: At 4½ months post Dose 3 ] [ Designated as safety issue: No ]
Haemoglobin [ Time Frame: At 4½ months post Dose 3. ] [ Designated as safety issue: No ]
Occurrence of solicited symptoms and local reactions. [ Time Frame: Over a 7-day follow-up period ] [ Designated as safety issue: No ]
Occurrence of unsolicited symptoms. [ Time Frame: Over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination. ] [ Designated as safety issue: No ]
Occurrence of serious adverse events [ Time Frame: From the time of first vaccination (Month 0) until 4½ months post Dose 3 (Month 6½). ] [ Designated as safety issue: No ]
Occurrence of parameters of hematological monitoring outside acceptable ranges. [ Designated as safety issue: No ]
Antibody to the P. falciparum circumsporozoite (CS) repeat domain (anti-CS antibody) titers. [ Time Frame: Prior to vaccination, 1 month post Dose 3 and 4½ months post Dose 3 ] [ Designated as safety issue: No ]
Anti-hepatitis B surface antigen (anti-HBs) titers [ Time Frame: Prior to vaccination and 1 month post Dose 3. ] [ Designated as safety issue: No ]
Frequency of CD4+ and CD8+ CS-specific T-cells expressing at least 2 of the following: IL-2, CD40L, TNF-α and IFN-у. [ Time Frame: Prior to vaccination and 1 month post Dose 3. ] [ Designated as safety issue: No ]

Enrollment:	855
Study Start Date:	January 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group B	Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine 3 dose intramuscular injection
Experimental: Group A	Biological: GSK malaria vaccine 257049 Vaccine 3 dose intramuscular injection Other Name: RTS, S/AS01E vaccine

Eligibility

Ages Eligible for Study:	5 Months to 17 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female child of between 5 months and 17 months of age 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.

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 acceptable limits.
Planned administration/administration of a vaccine not foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine.
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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380393

Locations

Kenya
GSK Investigational Site
Kilifi, Kenya, 80108
Tanzania
GSK Investigational Site
Amani, Tanga, Tanzania

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Horowitz A, Hafalla JC, King E, Lusingu J, Dekker D, Leach A, Moris P, Cohen J, Vekemans J, Villafana T, Corran PH, Bejon P, Drakeley CJ, von Seidlein L, Riley EM. Antigen-specific IL-2 secretion correlates with NK cell responses after immunization of Tanzanian children with the RTS,S/AS01 malaria vaccine. J Immunol. 2012 May 15;188(10):5054-62. Epub 2012 Apr 13.

Olotu A, Lusingu J, Leach A, Lievens M, Vekemans J, Msham S, Lang T, Gould J, Dubois MC, Jongert E, Vansadia P, Carter T, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Lapierre D, Ballou WR, Cohen J, Lemnge MM, Peshu N, Marsh K, Riley EM, von Seidlein L, Bejon P. Efficacy of RTS,S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5-17 months in Kenya and Tanzania: a randomised controlled trial. Lancet Infect Dis. 2011 Feb;11(2):102-9. Epub 2011 Jan 13.

Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, Olivier A, Benns S, Olomi R, Msham S, Lang T, Gould J, Hallez K, Guerra Y, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Dekker D, Malle L, Ismael S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Ballou WR, Cohen J, Riley EM, Lemnge MM, Marsh K, Bejon P, von Seidlein L. Safety of the malaria vaccine candidate, RTS,S/AS01E in 5 to 17 month old Kenyan and Tanzanian Children. PLoS One. 2010 Nov 29;5(11):e14090.

Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, Mshamu S, Lang T, Gould J, Dubois MC, Demoitié MA, Stallaert JF, Vansadia P, Carter T, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Ballou WR, Cohen J, Riley EM, Lemnge MM, Marsh K, von Seidlein L. Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. N Engl J Med. 2008 Dec 11;359(24):2521-32. Epub 2008 Dec 8.

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00380393 History of Changes
Other Study ID Numbers:	106464
Study First Received:	September 25, 2006
Last Updated:	September 3, 2009
Health Authority:	United States: Food and Drug Administration Tanzania: TFDA (Tanzania Food and Drugs Authority) Kenya: Ministry of Health - Pharmacy and Poisons Board

Keywords provided by GlaxoSmithKline:

RTS
S/AS01
Malaria
Plasmodium
Falciparum

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 16, 2013