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

• Conditions: Malaria
• Interventions: Biological: RTS,S/AS01E

• Registration Number: NCT00872963
• Lead Sponsor: KEMRI-Wellcome Trust Collaborative Research Program

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07
• Primary Completion: 2016-02
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RABIES VACCINE	RTS,S/AS01E	Those subjects who received the active comparator
RTS,S/AS01E	RTS,S/AS01E	The subjects who received investigational product

Primary Outcome Measures

Name	Time	Method
Long term febrile malaria episodes	4 years

Secondary Outcome Measures

Name	Time	Method
To compare the age distribution of episodes of malaria following vaccination with RTS,S with the age distribution following control vaccination.	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.	4 years

Trial Locations

Locations (1)

Kemri Wellcome Trust Research Programme; 🇰🇪 Kilifi, Coast Province, Kenya