Last updated: 11/07/2018 13:30:31
Double-blind, randomized phase I/IIa human challenge study, to evaluate the safety, reactogenicity, immunogenicity, and preliminary efficacy after primary sporozoite challenge and rechallenge, of GSK Biologicals’ candidate malaria vaccines containing the antigen RTS,S adjuvanted with either AS02A or AS01B and administered intramuscularly at months 0, 1, 2 in healthy malaria-naive volunteers aged 18 - 45 years
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Double-blind, randomized phase I/IIa human challenge study, to evaluate the safety, reactogenicity, immunogenicity, and preliminary efficacy after primary sporozoite challenge and rechallenge, of GSK Biologicals’ candidate malaria vaccines containing the antigen RTS,S adjuvanted with either AS02A or AS01B and administered intramuscularly at months 0, 1, 2 in healthy malaria-naive volunteers aged 18 - 45 years
Trial description: Double-blind, randomized phase I/IIa human challenge study, to evaluate the safety, reactogenicity, immunogenicity, and preliminary efficacy after primary sporozoite challenge and rechallenge, of GSK Biologicals’ candidate malaria vaccines containing the antigen RTS,S adjuvanted with either AS02A or AS01B and administered intramuscularly at months 0, 1, 2 in healthy malaria-naive volunteers aged 18 - 45 years
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kester KE et al. (2009) Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS,S/AS01B and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J Infect Dis. 200(3):337-346. doi: 10.1086/600120.
Lumsden JM et al. (2011) Protective immunity induced with the RTS,S/AS vaccine is associated with IL-2 and TNF-? producing effector and central memory CD4 T cells. PLoS ONE. 6(7):e20775. doi: 10.1371/journal.pone.0020775. Epub 2011 Jul 11.
Vahey MT et al. (2010) Expression of genes associated with immunoproteasome processing of major histocompatibility complex peptides is indicative of protection with adjuvanted RTS,S malaria vaccine. J Infect Dis. 201(4):580-589. doi: 10.1086/650310.
Medical condition
Malaria Vaccines
Product
SB257049
Collaborators
Not applicable
Study date(s)
February 2004 to January 2006
Type
Not applicable
Phase
1/2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-13-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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Access to clinical trial data by researchers
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