CONSISE has developed standardized research protocols for Influenza, MERS-CoV and Zika Virus (ZIKV)

For more information, support in adapting these protocols for local use or support in the implementing any of these studies, please contact Maria Van Kerkhove (maria.van-kerkhove@pasteur.fr)

CONSISE has drafted several standardized research protocols for influenza, MERS-CoV and Zika Virus (ZIKV).  Our standardized protocols have all been developed with large numbers of technical experts, including WHO and incorporate knowledge and experience learned from conducting epidemiologic studies all over the world.

All standardized protocols have been designed to maximize the likelihood that epidemiological, clinical and exposure data and biological samples are systematically collected and shared rapidly in a format that can be easily aggregated, tabulated and analyzed across many different settings globally. We encourage any and all study centres to contribute to this effort regardless of resource availability or patient volume. Ownership of the primary data remains with the individual sites.

We work closely with the World Health Organization in the development of all of our protocols, and also with our sister organization ISARIC (the International Severe Acute Respiratory and Emerging Infection Consortium), which focuses mainly on clinical research.

CONSISE Protocols Under Development

Influenza

CONSISE is in the process of developing seven standardized research protocols for influenza.

Standardized protocols for epidemic/pandemic influenza:

  • Protocol 1: Prospective longitudinal cohort study of influenza infection during epidemic periods
    • Primary Objective: Determine age specific cumulative incidence of infection during an influenza epidemic
  • Protocol 2: Cross sectional seroprevalence study of influenza prior and post epidemic periods
    • Primary Objectives: Determine age specific cumulative incidence of infection with a novel influenza virus in the population and Measure prevalence of cross-reactive antibodies to the novel
  • Protocol 3: Household transmission studies for pandemic influenza 
    • Primary Objectives: Estimate household secondary infection risk, and factors associated with variation in the secondary infection risk; Characterize secondary cases including clinical presentation and asymptomatic fraction; and  Investigate serological response following confirmed influenza infection
  • Protocol 4: Closed setting outbreak investigation protocol for pandemic influenza
    • Primary Objectives: Describe the clinical spectrum of infection including the asymptomatic fraction; Estimate overall clinical attack rates (by subgroup and clinical risk group); and Describe correlation between infection, disease and serology
  • Protocol 5: Assessment of health care personnel
    • Primary Objectives: Detect the presence of human-to-human transmission of a novel virus within a health care setting 

Standardized protocols for seasonal influenza:

  • Protocol 6: Seroepidemiology of human influenza infection using residual sera/convenience samples for establishing baselines and/or monitoring trends over time 
    • Primary Objectives: Estimate population immune status/susceptibility to relevant influenza viruses; Estimate incidence in previous-seasons for the different relevant influenza viruses

Standardized protocols for zoonotic influenza:

 

MERS-CoV

CONSISE members and WHO have developed four standardized research protocols for MERS-CoV.  These protocols are listed below and are available here and on the WHO MERS-CoV website:

 

ZIKV

CONSISE and the Institut Pasteur were asked to draft six standardized research protocols for Zika. Our expertise in rapidly drafting such technical documents, summoning and incorporating technical input have allowed us to support efforts to harmonize epidemiologic and clinical research for Zika.

The six protocols (listed below) were developed by CONSISE and Institut Pasteur and have undergone significant technical review by research and public health professionals working on Zika and other arborviruses. We worked closely with WHO, affected coutnries in the Americas and Caribbean and ISARIC to draft and finalize the protocols. 

The protocols currently available include:

  • Case-control study to assess potential risk factors related to microcephaly caused by Zika virus infection
  • Case-control study to assess potential risk factors related to Guillain-Barré Syndrome caused by Zika virus infection
  • Prospective longitudinal cohort study of women and newborns expsed to ZIKV during pregnancy
  • Prospective longitudinal cohort study of newborns and infants born to mothers exposed to Zika virus during pregnancy
  • Cross-sectional seroprevalence study of Zika virus infection in the general population
  • Prospective longitudinal cohort study of Zika-infected patients to measure the persistence of Zika virus in body fluids

All protocols are currently undergoing ethical review by WHO and the first version of these protocols are now available on the WHO website: http://origin.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/. For further information, please contact Maria Van Kerkhove (maria.van-kerkhove@pasteur.fr).

A seventh protocol (called the Clinical Characterization Protocol for Zika Virus Infection in the Context of Co-circulating Arborvirus) to better understand the natural history of ZIKV infection has been drafted by WHO, IDAMS and ISARIC.  THis protocol will also be available on the WHO website soon.

Read about the development of the ZIKV research protocols here: Van Kerkhove MD, Reveiz L, Souza JP, Jaenisch T, Carson G, Broutet N for the Working Group on ZIKV Harmonized Research.  Harmonization of Zika virus research protocols to address key public health questions.  Lancet Global Health. Published 1 November 2016.