Malaria Vaccine Pilot Evaluation

NCT03806465 | Completed DMC

• 1 other identifier: RTSS MVPE
• Study Type: observational
• Target: 30,124
• Locations: 3 countries
• Sites: 3

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

Conditions

Malaria,Falciparum; Feasibility; Safety; Mortality

Keywords

Vaccine; Malaria; Africa; Child

Outcome Measures

Primary Outcomes (5)

• The number of deaths of any cause

  Number of deaths of any cause in children aged 1-59 months.

  From 0 to 46 months after vaccination starts

• Number of children admitted with a diagnosis of probable and confirmed meningitis cases

  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.

  From 0 to 30 months after vaccination starts

• Number of children admitted with a diagnosis of cerebral malaria

  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)

  From 0 to 30 months after vaccination starts

• Number of children aged 12-23 months who have completed the primary series (the 3 dose regime) of the malaria vaccine

  Prevalence of children aged 12-23 months who had completed three doses of RTS,S/AS01 at the second household survey

  At 18 months after vaccination starts

• Number of children aged 27-38 months who have completed the 4th dose of the malaria vaccine

  Prevalence of children aged 27-38 months who had completed four doses of RTS,S/AS01 at the third household survey

  At 30 months after vaccination starts

Secondary Outcomes (14)

• Number of deaths in children by gender

  From 0 to 46 months after vaccination starts

• Number of deaths in hospitalised children by gender

  From 0 to 46 months after vaccination starts

• Number of malaria associated deaths in hospitalised children by gender

  From 0 to 46 months after vaccination starts

• Number of children with a diagnosis of severe malaria

  From 0 to 30 months after vaccination starts

• Number of deaths excluding those attributed to trauma, poisoning and drowning

  From 0 to 46 months after vaccination starts

Study Arms (3)

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

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

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

Interventions

Feasibility survey OTHER

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.

Feasibility survey

Sentinel hospital surveillance OTHER

Cerebrospinal samples will be collected from all children hospitalised and suspected of having meningitis.

Sentinel hospital surveillance

Community mortality surveillance OTHER

A verbal autopsy will be performed

Community mortality surveillance

Eligibility Criteria

• Age: 1 Month - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Children aged 1-59 months

You may not qualify if:

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

Sponsors & Collaborators

• Rafiq OKINE: lead

Study Sites (3)

Kintampo Health Research Centre

Kintampo, Ghana

Location

CDC Kenya Malaria Programme

Kisumu, Kenya

Location

College of Medicine

Blantyre, Malawi

Location

Related Publications (3)

• Malaria vaccine: WHO position paper-January 2016. Wkly Epidemiol Rec. 2016 Jan 4;91(4):33-51. No abstract available. English, French.

  PMID: 26829826 BACKGROUND

• RTS,S Clinical Trials Partnership. Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial. Lancet. 2015 Jul 4;386(9988):31-45. doi: 10.1016/S0140-6736(15)60721-8. Epub 2015 Apr 23.

  PMID: 25913272 BACKGROUND

• Hoyt J, Okello G, Bange T, Kariuki S, Jalloh MF, Webster J, Hill J. RTS,S/AS01 malaria vaccine pilot implementation in western Kenya: a qualitative longitudinal study to understand immunisation barriers and optimise uptake. BMC Public Health. 2023 Nov 18;23(1):2283. doi: 10.1186/s12889-023-17194-2.

  PMID: 37980467 DERIVED

Related Links

• Key milestones in the development of the Malaria Vaccine Implementation Programme (MVIP): from pilot recommendation to vaccine introduction

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 16, 2019
• Study Start: February 25, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

GH (1); MA (1); KE (1)