This trial is active, not recruiting.

Condition malaria
Treatment rts,s/as01e
Phase phase 2/phase 3
Sponsor KEMRI-Wellcome Trust Collaborative Research Program
Collaborator GlaxoSmithKline
Start date February 2009
End date February 2016
Trial size 450 participants
Trial identifier NCT00872963, SSC 1512


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Those subjects who received the active comparator
rts,s/as01e rabies vaccine BP, Sanofi-Pasteur
0.5MLS of RTS,S/AS01E at 0,1,2 monthly schedule 0.5mls Rabies vaccine at 0,1,2 monthly schedule
The subjects who received investigational product
rts,s/as01e rabies vaccine BP, Sanofi-Pasteur
0.5MLS of RTS,S/AS01E at 0,1,2 monthly schedule 0.5mls Rabies vaccine at 0,1,2 monthly schedule

Primary Outcomes

Long term febrile malaria episodes
time frame: 4 years

Secondary Outcomes

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
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

Eligibility Criteria

Male or female participants from 19 months up to 35 months old.

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.

Additional Information

Official title An Extended Follow up of a Phase 2b Vaccine Trial With RTS,S/AS01E in Kilifi District, Kenya.
Principal investigator Ally Olotu
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by KEMRI-Wellcome Trust Collaborative Research Program.