Non-specific Effects of Vaccination on Mortality and Morbidity
NOVAC
The Non-specific Effects of Vaccination Related to Mortality and Morbidity in Nanoro Health and Demographic Surveillance System Cohort
1 other identifier
observational
1,005
1 country
1
Brief Summary
It has long been recognized that the positive effects of vaccination on childhood mortality cannot be solely attributed to a decline in the disease targeted by the vaccine. These so-called non-specific effects of vaccination have so far mostly been linked to mortality. However, it has been suggested that non-specific effects may also effect morbidity and nutritional status. This study aims to further explore the correlation between vaccination, susceptibility to infectious diseases (particularly malaria and bacterial infections), nutritional status and immunity. With this prospective cross sectional study among healthy individuals in rural west-Africa we aim to address several research questions at the same time. This study will assess the influence of (time-point of) vaccination on morbidity, mortality and immune status among healthy individuals in a rural sub-Saharan African setting. Secondly, to explore the prevalence of subclinical malaria, iron deficiency anemia, sickle cell anemia and thallasemia among a healthy rural sub-Saharan African population. And finally to assess normal hemocytometry values among a healthy rural sub-Saharan African population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedStudy Start
First participant enrolled
June 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedSeptember 4, 2018
August 1, 2018
5 months
May 18, 2017
August 31, 2018
Conditions
Outcome Measures
Primary Outcomes (8)
Vaccination data
Vaccination data as recorded on the vaccination card
June 2017 - December 2017
Nutritional status (Z-score or BMI)
weight (kg), height (cm) and upperarm circumference (mm) leading to outcome measure on nutritional status: as appropriate Z-score or BMI
June 2017 - December 2017
History of disease
Recorded history of disease according to the participants health card
June 2017 - December 2017
Immunological profile
Cytokine levels, including IL-1b, IL-6, IL-10, IFN-gamma, TNF-alpha and IL-17, which will be assessed through ELISA. Measurement will be done on stimulated and unstimulated blood. Ex-vivo whole blood stimulation will be done with RPMI, LPS, MTB, Staphylococcus aureus, Candida albicans and Salmonella Typhimurium.
June 2017 - December 2017
Genetic immunological profile
DNA analysis to assess genetic variations determining pro- versus anti inflammatory response including mTOR, HK2, PFKP, GLS, and GLUD1/2.
June 2017 - December 2017
subclinical parasitemia
low level malaria infection detected by SYSMEX hematology analyzer XN - 30
June 2017 - December 2017
Anemia
Differentiation of different forms of anemia using SYSMEX hematology analyzers XN -20 and XN - 30
June 2017 - December 2017
Reference values for hemocytometry in a healthy rural population from Burkina Faso
Hemocytometry using SYSMEX hematology analyzers XN -20 and XN - 30
June 2017 - December 2017
Secondary Outcomes (1)
Gametocyte PCR
June 2017 - December 2017
Other Outcomes (1)
Salmonella PCR
June 2017 - December 2017
Study Arms (5)
Children of 1 years old
200 healthy volunteers aged between 12 and 23 months
Children aged 2-4
200 healthy volunteers aged between 24 and 59 months
Children aged 5 - 9
200 healthy volunteers aged between 60 and 119 months
Children aged 10 - 14
200 healthy volunteers aged between 120 and 179 months
Adults of 15 years and older
200 healthy volunteers of 180 months or older
Interventions
1. Full blood count and leukocyte differentiation. 2. Detection of malaria parasites and parasite differentiation to trophozoites, gametocytes and ringstages (XN-30) 3. Detection of anemia, thallasemia and sickle cell anemia (XN-20) 4. Ex-vivo stimulation of wholeblood with various stimuli. Read-out will be a spectrum of cytokines (ELISA) 5. Circulating cytokines and inflammatory markers (ELIZA) 6. DNA analysis to assess genetic variations determining pro- versus anti inflammatory response including mTOR, HK2, PFKP, GLS, and GLUD1/2. 7. pan-Salmonella PCR 8. Gametocyte PCR
Eligibility Criteria
A total of 5 groups will be selected. Each age group will consist of 220 participant (including 20% for potential non response). The survey will be conducted among 24 villages. Demographic age distribution is comparable for each of the villages. In order to prevent bias, a proportionate number of participants will be selected from each village based on its total population. Participants will then be randomly selected from each sample stratum using systematic selection.
You may qualify if:
- Healthy participants currently living in the Nanoro HDSS area, born before May 2016.
You may not qualify if:
- Current febrile illness,
- Current chronic illnesses, HIV, TB, renal failure, cardiac disease (if known)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Unit of Nanoro
Nanoro, Boulkiemedé, Burkina Faso
Related Publications (1)
Kabore B, Post A, Berendsen MLT, Diallo S, Lompo P, Derra K, Rouamba E, Jacobs J, Tinto H, de Mast Q, van der Ven AJ. Red blood cell homeostasis in children and adults with and without asymptomatic malaria infection in Burkina Faso. PLoS One. 2020 Nov 30;15(11):e0242507. doi: 10.1371/journal.pone.0242507. eCollection 2020.
PMID: 33253198DERIVED
Biospecimen
EDTA blood and heparizined blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
André van der Ven, Prof. Dr.
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2017
First Posted
June 5, 2017
Study Start
June 17, 2017
Primary Completion
October 31, 2017
Study Completion
December 31, 2018
Last Updated
September 4, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share