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Non-specific Effects of Vaccination on Mortality and Morbidity (NOVAC)

This study is currently recruiting participants.
Verified June 2017 by Radboud University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176719
First Posted: June 5, 2017
Last Update Posted: October 10, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Clinical Research Unit of Nanoro
Information provided by (Responsible Party):
Radboud University
  Purpose

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.


Condition Intervention
Vaccine Reaction Anemia Malaria,Falciparum Salmonella Bacteraemia Other: Venipuncture

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: The Non-specific Effects of Vaccination Related to Mortality and Morbidity in Nanoro Health and Demographic Surveillance System Cohort

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Vaccination data [ Time Frame: June 2017 - December 2017 ]
    Vaccination data as recorded on the vaccination card

  • Nutritional status (Z-score or BMI) [ Time Frame: June 2017 - December 2017 ]
    weight (kg), height (cm) and upperarm circumference (mm) leading to outcome measure on nutritional status: as appropriate Z-score or BMI

  • History of disease [ Time Frame: June 2017 - December 2017 ]
    Recorded history of disease according to the participants health card

  • Immunological profile [ Time Frame: June 2017 - December 2017 ]
    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.

  • Genetic immunological profile [ Time Frame: June 2017 - December 2017 ]
    DNA analysis to assess genetic variations determining pro- versus anti inflammatory response including mTOR, HK2, PFKP, GLS, and GLUD1/2.

  • subclinical parasitemia [ Time Frame: June 2017 - December 2017 ]
    low level malaria infection detected by SYSMEX hematology analyzer XN - 30

  • Anemia [ Time Frame: June 2017 - December 2017 ]
    Differentiation of different forms of anemia using SYSMEX hematology analyzers XN -20 and XN - 30

  • Reference values for hemocytometry in a healthy rural population from Burkina Faso [ Time Frame: June 2017 - December 2017 ]
    Hemocytometry using SYSMEX hematology analyzers XN -20 and XN - 30


Secondary Outcome Measures:
  • Gametocyte PCR [ Time Frame: June 2017 - December 2017 ]
    Gametocyte PCR on EDTA whole blood stored in RNA protect


Other Outcome Measures:
  • Salmonella PCR [ Time Frame: June 2017 - December 2017 ]
    Salmonella PCR on EDTA whole blood (ethical clearance not yet obtained, amendment in progress)


Biospecimen Retention:   Samples With DNA
EDTA blood and heparizined blood

Estimated Enrollment: 1000
Actual Study Start Date: June 17, 2017
Estimated Study Completion Date: July 31, 2018
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children of 1 years old
200 healthy volunteers aged between 12 and 23 months
Other: Venipuncture
  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
Children aged 2-4
200 healthy volunteers aged between 24 and 59 months
Other: Venipuncture
  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
Children aged 5 - 9
200 healthy volunteers aged between 60 and 119 months
Other: Venipuncture
  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
Children aged 10 - 14
200 healthy volunteers aged between 120 and 179 months
Other: Venipuncture
  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
Adults of 15 years and older
200 healthy volunteers of 180 months or older
Other: Venipuncture
  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

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Healthy participants currently living in the Nanoro HDSS area, born before May 2016.

Exclusion Criteria:

  • Current febrile illness,
  • Current chronic illnesses, HIV, TB, renal failure, cardiac disease (if known)
  • Patients that have participated in the RTSS vaccination trial from Glaxo-Smith-Kline at the same inclusion site.
  Contacts and Locations
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): NCT03176719


Contacts
Contact: Berenger Kabore, MD, MSc +22671947481 kaboreberenger@gmail.com
Contact: Annelies Post, MD, MSc annelies.post@gmail.com

Locations
Burkina Faso
Clinical Research Unit of Nanoro Recruiting
Nanoro, Boulkiemedé, Burkina Faso
Contact: Berenger Kaboré, MD, MSc         
Sponsors and Collaborators
Radboud University
Clinical Research Unit of Nanoro
Investigators
Principal Investigator: André van der Ven, Prof. Dr. Radboud University
  More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03176719     History of Changes
Other Study ID Numbers: 2017-3339
First Submitted: May 18, 2017
First Posted: June 5, 2017
Last Update Posted: October 10, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bacteremia
Malaria, Falciparum
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Malaria
Protozoan Infections
Parasitic Diseases