An Extended Follow up of a RTS,S/AS01E Malaria Vaccine Trial (MAL059)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Biological: RTS,S/AS01E |
Phase 2 Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | An Extended Follow up of a Phase 2b Vaccine Trial With RTS,S/AS01E in Kilifi District, Kenya. |
- Long term febrile malaria episodes [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- 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 ]
Biospecimen Retention: Samples Without DNA
Yearly cross sectional bleeds to collect blood samples.
| Estimated Enrollment: | 450 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
RABIES VACCINE
Those subjects who received the active comparator
|
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
|
|
RTS,S/AS01E
The subjects who received investigational product
|
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
|
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.
Eligibility| Ages Eligible for Study: | 19 Months to 35 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00872963
| Kenya | |
| Kemri Wellcome Trust Research Programme | |
| Kilifi, Coast Province, Kenya, 80108 | |
| Principal Investigator: | Ally Olotu | KEMRI-Wellcome Trust Collaborative Research Program |
More Information
No publications provided by KEMRI-Wellcome Trust Collaborative Research Program
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | KEMRI-Wellcome Trust Collaborative Research Program |
| ClinicalTrials.gov Identifier: | NCT00872963 History of Changes |
| Other Study ID Numbers: | SSC 1512 |
| Study First Received: | March 31, 2009 |
| Last Updated: | July 23, 2014 |
| Health Authority: | Kenya: Ethical Review Committee |
Keywords provided by KEMRI-Wellcome Trust Collaborative Research Program:
|
malaria vaccine RTS,S, |
ClinicalTrials.gov processed this record on March 02, 2015