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Simian Foamy Virus Transmission to Humans

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ClinicalTrials.gov Identifier: NCT03225794
Recruitment Status : Unknown
Verified August 2018 by Institut Pasteur.
Recruitment status was:  Recruiting
First Posted : July 21, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

Brief Summary:

About three quarters of the viral agents that have emerged recently in humans are considered to originate from other animals. These viruses have often evolved and spread into the human population through various mechanisms after the initial contact that resulted in interspecies transmission. However, knowledge of the initial stages of the emergence of viruses and associated diseases is still limited in many cases. Microbiological monitoring in populations at risk of transmission would provide insights into the initiation and early stages of the emergence process.

Nonhuman primates (NHPs) share many genetic, physiological, and microbiological features with humans, and are potential sources of many infectious agents. This has been demonstrated for several simian retroviruses. HIV-1 and 2 are believed to have originated from chimpanzee and mangabey viruses, respectively, found in Central and West Africa. The current distribution of the various molecular subtypes of the HTLV-1 oncogenic retrovirus in Africa is mainly the result of numerous instances of interspecies transmission of STLV-1from NHP species in the distant past.

Foamy viruses belong to the Retrovidae family and the Spumavirus genus. They are complex exogenous retroviruses and are very common in many animal species, including primates, cats, cattle, and horses, in which they cause persistent infections.

The first aim of the work is to study the epidemiological and molecular aspects of the transmission of foamy viruses from monkeys to humans in populations at risk, such as the inhabitants (especially hunters) in the villages of the dense forests of southern Cameroon. It is an area in which NHPs are still very common, with a great diversity of species. The investigators have already shown that the prevalence of foamy viruses is very high in these monkeys and great apes (gorillas and chimpanzees). Contact between these monkeys and the villagers is very frequent, mainly during hunting. The second aim of the project is to study the clinical and biological features of infected people and investigate intrafamilial transmission from infected index cases.


Condition or disease Intervention/treatment
Simian Foamy Virus Infection (Disorder) Diagnostic Test: Simian foamy virus Infection

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Epidemiological and Molecular Aspects of the Interspecies Transmission of Foamy Viruses From Monkeys to Humans: A Model of the Early Stages of Viral Emergence.
Actual Study Start Date : November 1, 2010
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Group/Cohort Intervention/treatment
Controls
Adults living in rural area of Cameroon, not infected with simian foamy viruses
Diagnostic Test: Simian foamy virus Infection
Plasma samples are tested for the presence of antibodies directed against foamy viruses by western blotting (WB). The BHK-21 cell line infected with a chimpanzee foamy virus is used as a source of viral antigen. Samples are considered to be positive if there is net reactivity against the GAG doublet (70 to 74 kD). High molecular weight DNA will be extracted, from either buffy coats, cell cultures, or both, for molecular biology studies. The presence and quality of the DNA will be verified by amplification of a fragment of the beta-globin gene. Two regions of foamy virus genomic DNA will be amplified by nested PCR, using generic amplimers, giving rise to fragments of the integrase gene (425 bp) and LTR (109 bp).

Simian Foamy virus infection
Adults living in rural area of Cameroon, infected with simian foamy viruses
Diagnostic Test: Simian foamy virus Infection
Plasma samples are tested for the presence of antibodies directed against foamy viruses by western blotting (WB). The BHK-21 cell line infected with a chimpanzee foamy virus is used as a source of viral antigen. Samples are considered to be positive if there is net reactivity against the GAG doublet (70 to 74 kD). High molecular weight DNA will be extracted, from either buffy coats, cell cultures, or both, for molecular biology studies. The presence and quality of the DNA will be verified by amplification of a fragment of the beta-globin gene. Two regions of foamy virus genomic DNA will be amplified by nested PCR, using generic amplimers, giving rise to fragments of the integrase gene (425 bp) and LTR (109 bp).




Primary Outcome Measures :
  1. Infection with simian foamy virus by determination of the presence of specific antibodies in plasma [ Time Frame: 3 years ]
    Determination of the presence of specific antibodies in plasma through a positive western blot for foamy virus

  2. Infection with simian foamy virus by determination of the presence viral DNA in blood cells [ Time Frame: 3 years ]
    Determination of the presence viral DNA in blood cells through a positive PCR assay using generic amplimers, giving rise to fragments of the integrase gene (425 bp) and LTR (109 bp).


Biospecimen Retention:   Samples With DNA
Blood draw into a 5/10 ml EDTA tubes; Oral specimens will be collected by rubbing the inside of the cheek with a swab and then rinsing the mouth and collecting the rinse liquid in a sterile bottle.


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The survey has been and will be carried out in villages in southern Cameroon and the target population will change during the four phases of the study as follows:

  1. Initially, all adults encountered (Phase 1).
  2. In the second phase, people who have been in physical contact with monkeys (bites, scratches, wounds, etc.) mainly during hunting and the cleaning of bushmeat
  3. Finally, after screening: focus on infected individuals and inclusion of their immediate family (mainly spouses and children) to study potential intrafamilial transmission (Phase 3).
  4. For infected individuals, an annual clinical, biological and immunological examination, for 3 years (Phase 4). An uninfected person matched for age, sex, ethnic group, and locality will be recruited as a control for each case.
Criteria

Inclusion Criteria:

  • Living in a rural zone of Cameroon
  • Being > 5 yrs old
  • Having received study information and having provided written consent for self and children, if applicable (for all phases)

Exclusion Criteria:

  • Having refused to provide consent
  • Being less than 5 years old

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): NCT03225794


Contacts
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Contact: Antoine GESSAIN, MD +33 1 45 68 89 37 antoine.gessain@pasteur.fr
Contact: Florence BUSEYNE, PhD + 33 1 45 68 88 99 florence.buseyne@pasteur.fr

Locations
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Cameroon
Centre Pasteur du CAmeroun Recruiting
Yaoundé, Cameroon
Contact: Edouard Betsem, MD         
Sponsors and Collaborators
Institut Pasteur
Investigators
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Principal Investigator: Antoine GESSAIN, MD Institut Pasteur
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03225794    
Other Study ID Numbers: 2010-27
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Pasteur:
Retrovirus
Viral emergence
Additional relevant MeSH terms:
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Virus Diseases