An Extended Follow up of a RTS,S/AS01E Malaria Vaccine Trial (MAL059)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by KEMRI-Wellcome Trust Collaborative Research Program.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
KEMRI-Wellcome Trust Collaborative Research Program
ClinicalTrials.gov Identifier:
NCT00872963
First received: March 31, 2009
Last updated: November 5, 2012
Last verified: March 2009

March 31, 2009
November 5, 2012
February 2009
February 2013   (final data collection date for primary outcome measure)
Long term febrile malaria episodes [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00872963 on ClinicalTrials.gov Archive Site
  • To compare the age distribution of episodes of malaria following vaccination with RTS,S with the age distribution following control vaccination. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To compare the in vitro markers of naturally acquired immunity in vaccinated and unvaccinated children, and assess the associations of these markers with subsequent episodes of febrile malaria. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Extended Follow up of a RTS,S/AS01E Malaria Vaccine Trial
An Extended Follow up of a Phase 2b Vaccine Trial With RTS,S/AS01E in Kilifi District, Kenya.

Malaria is one of the leading causes of deaths in children below five years old. Despite antimalarial drugs and insecticide treated bed nets, the established means of treatment and protection, malaria still continues to affect many children. A malaria vaccine would be a very effective way of reducing malaria infection in the community. RTS,S/AS01E is a leading malaria vaccine candidate which is being developed for children in Africa. The investigators have done a study to find out if this vaccine is effective in reducing infection by malaria in children aged 5-17 months living in Kenya and Tanzania. The follow up of the original study was 14-18 months. The extended follow up is proposed to continue for another four years.

The RTS,S/AS01E candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas as part of the Expanded Program of Immunization (EPI). 30% efficacy against clinical malaria and 58% efficacy against severe malaria disease was seen with a related vaccine, RTS,S/AS02A, in children aged 1 to 4 years (Malaria-026) in Mozambique. The efficacy against clinical malaria and infection was sustained beyond 18 months. The RTS,S/AS01 vaccines have been developed in parallel with the RTS,S/AS02 vaccines, and differ in the adjuvant formulation which has been shown to be more immunogenic.The utility of a partially effective vaccination depends heavily on the overall effect of malaria incidence during a child‟s acquisition of natural immunity. However, other cohorts vaccinated in Phase II studies have already discontinued follow up for episodes of malaria, and the planned Phase III studies will run for at most 30 months post vaccination. The proposed extended follow up is expected to run for four years and will inform the design of Phase 4 studies and may prove critical in informing public health policy once the vaccine is licensed.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Yearly cross sectional bleeds to collect blood samples.

Non-Probability Sample

The local population is predominantly from Mijikenda ethnic group. The study area is within Kilifi District at the Kenyan coast and majority are subsistence farmers.Kilifi District experiences long rains in May-July and short rains in November/December. Measured Entomological Inoculation Rates in the area vary from 10-50 per year.

Malaria
Biological: RTS,S/AS01E
0.5MLS of RTS,S/AS01E at 0,1,2 monthly schedule 0.5mls Rabies vaccine at 0,1,2 monthly schedule
Other Name: rabies vaccine BP, Sanofi-Pasteur
  • RABIES VACCINE
    Those subjects who received the active comparator
    Intervention: Biological: RTS,S/AS01E
  • RTS,S/AS01E
    The subjects who received investigational product
    Intervention: Biological: RTS,S/AS01E
Olotu A, Fegan G, Wambua J, Nyangweso G, Awuondo KO, Leach A, Lievens M, Leboulleux D, Njuguna P, Peshu N, Marsh K, Bejon P. Four-year efficacy of RTS,S/AS01E and its interaction with malaria exposure. N Engl J Med. 2013 Mar 21;368(12):1111-20. doi: 10.1056/NEJMoa1207564.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
August 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrollment and vaccination in the RTS,S/AS01E clinical trial (NCT00380393)
  • Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.

Exclusion Criteria:

  • Moving out of the study area, so that follow up is impractical.
Both
19 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00872963
SSC 1512
Yes
KEMRI-Wellcome Trust Collaborative Research Program
KEMRI-Wellcome Trust Collaborative Research Program
GlaxoSmithKline
Principal Investigator: Ally Olotu KEMRI-Wellcome Trust Collaborative Research Program
KEMRI-Wellcome Trust Collaborative Research Program
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP