An Extended Follow up of a RTS,S/AS01E Malaria Vaccine Trial - Full Text View

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.

Resource links provided by NLM:

MedlinePlus related topics: Malaria Rabies

Drug Information available for: Rabies Vaccine

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Further study details as provided by KEMRI-Wellcome Trust Collaborative Research Program:

Primary Outcome Measures:

Long term febrile malaria episodes [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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 Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872963

Locations


Kenya
Kemri Wellcome Trust Research Programme
Kilifi, Coast Province, Kenya, 80108

Sponsors and Collaborators

KEMRI-Wellcome Trust Collaborative Research Program

GlaxoSmithKline

Investigators


Principal Investigator:	Ally Olotu	KEMRI-Wellcome Trust Collaborative Research Program

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Olotu A, Fegan G, Wambua J, Nyangweso G, Leach A, Lievens M, Kaslow DC, Njuguna P, Marsh K, Bejon P. Seven-Year Efficacy of RTS,S/AS01 Malaria Vaccine among Young African Children. N Engl J Med. 2016 Jun 30;374(26):2519-29. doi: 10.1056/NEJMoa1515257.

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.


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:	December 4, 2015
Health Authority:	Kenya: Ethical Review Committee

Keywords provided by KEMRI-Wellcome Trust Collaborative Research Program:


malaria vaccine RTS,S,

Additional relevant MeSH terms:


Malaria Protozoan Infections Parasitic Diseases	Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016

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