Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Malaria Vaccine Evaluation Programme (MVPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806465
Recruitment Status : Active, not recruiting
First Posted : January 16, 2019
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Patricia Njuguna, World Health Organization

Brief Summary:

The RTS,S/AS01 malaria vaccine is being introduced sub-nationally in phased pilot introductions through the EPI programmes in Malawi Ghana and Kenya. Vaccine introduction is by the respective MoH in selected areas randomly assigned to receive the vaccine at the beginning of the pilots. In the context of this programmatic activity, the Malaria Vaccine Pilot Evaluation (MVPE) registered here as observational evaluations during early vaccine introduction, include a series of 3 household surveys, and sentinel hospital and community mortality surveillance, building on routine systems.

These observational evaluations will measure:

  1. The programmatic feasibility of delivering a 4 dose schedule;
  2. Safety in routine use, with focus on cerebral malaria and meningitis;
  3. The impact of the malaria vaccine in routine use on severe malaria and all-cause mortality

Condition or disease Intervention/treatment
Malaria,Falciparum Feasibility Safety Mortality Other: Feasibility survey Other: Sentinel hospital surveillance Other: Community mortality surveillance

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 15800 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Evaluation of the Pilot Implementation of RTS,S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort Intervention/treatment
Feasibility survey
These will be children living in the vaccinating and in non-vaccinating areas aged less than 5 years of age. For the midline household survey, this would be restricted to children aged 12-23 months of age.
Other: Feasibility survey
A survey questionnaire will be administered at each household. At the baseline household survey, each child aged less than 5 years will be tested for malaria using a rapid malaria test.

Sentinel hospital surveillance
These will be children living in the vaccinating and in non-vaccinating areas aged less than 5 years of age who are hospitalized in the 18 sentinel hospitals.
Other: Sentinel hospital surveillance
Cerebrospinal samples will be collected from all children hospitalised and suspected of having meningitis.

Community mortality surveillance
These will be children whose deaths are reported in the vaccinating and in non-vaccinating areas aged less than 5 years of age .
Other: Community mortality surveillance
A verbal autopsy will be performed




Primary Outcome Measures :
  1. The number of deaths of any cause [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of deaths of any cause in children aged 1-59 months.

  2. Number of children admitted with a diagnosis of probable and confirmed meningitis cases [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of children with probable and confirmed meningitis A probable case if in a suspected case, the macroscopic aspect of the CSF is turbid, cloudy or purulent; or the CSF leukocyte count is >10 cells/mm3. A confirmed case is if a suspected or probable case is laboratory confirmed by culturing or identifying (i.e. by polymerase chain reaction, immunochromatographic dipstick or latex agglutination) bacterial, viral or other aetiology in the CSF.

  3. Number of children admitted with a diagnosis of cerebral malaria [ Time Frame: From 0 to 30 months after vaccination starts ]
    Cerebral malaria is defined as Severe P. falciparum malaria with coma (Glasgow coma score < 11 in children two years of age or older [≥ 2 years] or Blantyre coma score < 3 in children less than two years of age [(< 2 years]); and If malaria with seizure: coma persisting for > 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis)

  4. Number of children aged 12-23 months who have completed the primary series (the 3 dose regime) of the malaria vaccine [ Time Frame: At 18 months after vaccination starts ]
    Prevalence of children aged 12-23 months who had completed three doses of RTS,S/AS01 at the second household survey

  5. Number of children aged 27-38 months who have completed the 4th dose of the malaria vaccine [ Time Frame: At 30 months after vaccination starts ]
    Prevalence of children aged 27-38 months who had completed four doses of RTS,S/AS01 at the third household survey


Secondary Outcome Measures :
  1. Number of deaths in children by gender [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of deaths in children stratified by gender in children aged 1-59 months

  2. Number of deaths in hospitalised children by gender [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of deaths in hospitalized children stratified by gender in children aged 1-59 months.

  3. Number of malaria associated deaths in hospitalised children by gender [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of malaria specific deaths stratified by gender in hospitalized children aged 1-59 months.

  4. Number of children with a diagnosis of severe malaria [ Time Frame: From 0 to 30 months after vaccination starts ]
    Hospital admissions with malaria which meet WHO criteria for a diagnosis of severe malaria.

  5. Number of deaths excluding those attributed to trauma, poisoning and drowning [ Time Frame: From 0 to 46 months after vaccination starts ]
    Number of non traumatic deaths in children aged 1-59 months.

  6. Number of children with a diagnosis of aetiology confirmed meningitis [ Time Frame: 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of aetiologically confirmed meningitis admitted to sentinel hospitals

  7. Number of children with a diagnosis of suspected meningitis [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of suspected meningitis admitted to sentinel hospitals

  8. Number of children with a diagnosis of probable meningitis [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of probable meningitis admitted to sentinel hospitals

  9. Number of children with a diagnosis of malaria [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of malaria admitted to sentinel hospitals

  10. Number of children with a non-malaria diagnosis [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which do not meet WHO criteria for a diagnosis of malaria admitted to sentinel hospitals

  11. Number of children with a diagnosis of anaemia [ Time Frame: From 0 to 30 months after vaccination starts ]
    Number of hospital admissions which meet WHO criteria for a diagnosis of anaemia admitted to sentinel hospitals . Anaemia is haemoglobin less than 11g/dL.

  12. Number of children who have received all their routine EPI vaccines as recommended by their national immunization schedule [ Time Frame: At 18 and 30 months after vaccination starts ]
    Routine EPI vaccines include all doses of OPV, pentavalent, rotavirus, pneumococcal and measles vaccines

  13. Number of children who have received all the recommended malaria prevention and control measures [ Time Frame: At 18 and 30 months after vaccination starts ]
    Recommended malaria prevention and control measures include insecticide treated bed nets, IPTi and indoor residual spraying.

  14. Number of children who have received all of the other key childhood interventions [ Time Frame: At 18 and 30 months after vaccination starts ]
    Other key childhood interventions include anti-helminth administration (deworming) and Vitamin A supplementation


Biospecimen Retention:   Samples Without DNA
Cerebrospinal fluid


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will comprise children aged 1-59 months living in the areas geographically-defined for this evaluation of the RTS,S/AS01 Malaria Vaccine Implementation in three countries (Ghana, Kenya and Malawi) in sub-Saharan Africa.
Criteria

Inclusion Criteria:

  • Children aged 1-59 months

Exclusion Criteria:

  • Children aged less than 1 month or greater than 59 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806465


Locations
Layout table for location information
Ghana
Kintampo Health Research Centre
Kintampo, Ghana
Kenya
CDC Kenya Malaria Programme
Kisumu, Kenya
Malawi
College of Medicine
Blantyre, Malawi
Sponsors and Collaborators
World Health Organization
Investigators
Layout table for investigator information
Principal Investigator: Don Mathanga, PhD College of Medicine, Malawi
Principal Investigator: Kwaku Poku Asante, PhD Kintampo Health Research Centre, Ghana
Principal Investigator: Aaron Samuels, MD CDC-Kenya Malaria Program
  Study Documents (Full-Text)

Documents provided by Patricia Njuguna, World Health Organization:
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Patricia Njuguna, Medical Officer, World Health Organization
ClinicalTrials.gov Identifier: NCT03806465    
Other Study ID Numbers: RTSS MVIP
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Njuguna, World Health Organization:
Vaccine
Malaria
Africa
Child
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases