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

Malaria Clinical Trial

— MAL059  

Official title:

An Extended Follow up of a Phase 2b Vaccine Trial With RTS,S/AS01E in Kilifi District, Kenya.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00872963
• Other study ID #: SSC 1512
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: March 31, 2009
• Last updated: December 4, 2015
• Start date: February 2009
• Est. completion date: August 2016

Study information

• Verified date: December 2015
• Source: KEMRI-Wellcome Trust Collaborative Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: August 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Months to 35 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria

Intervention

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

Locations

Country	Name	City	State
Kenya	Kemri Wellcome Trust Research Programme	Kilifi	Coast Province

Sponsors (2)

Lead Sponsor	Collaborator
KEMRI-Wellcome Trust Collaborative Research Program	GlaxoSmithKline

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term febrile malaria episodes		4 years	No
Secondary	To compare the age distribution of episodes of malaria following vaccination with RTS,S with the age distribution following control vaccination.		4 years	No
Secondary	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	No