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Not yet recruitingNCT07921641OROV-IMMUpdated Nov 6, 2026

Characterization of Adaptive Immune Responses to Oropouche Virus (OROV) Infection

An observational study in Oropouche Infection, sponsored by Institut Pasteur. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Institut Pasteur · Observational

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study summary

Oropouche virus (OROV), a re-emerging South American arbovirus causing dengue-like fever and occasional neurological complications, is expanding its circulation towards more densely populated areas in French Guiana, as evidenced by recent cases near Cayenne in 2026. While animal models indicate that B cell-mediated humoral immunity is critical for viral control, the human antibody response to OROV remains poorly characterized. Despite WHO-led international research efforts, there is currently no vaccine, antiviral treatment, or described human monoclonal antibody against OROV - a major gap that hinders therapeutic and vaccine development. Identifying human neutralizing monoclonal antibodies could offer a promising therapeutic option, particularly for vulnerable populations such as pregnant women.

Read the detailed description

The goal of this project is to characterize the adaptive immune response to OROV infection during the convalescent phase.

The study is based on three complementary populations: (1) 17 adults with confirmed past OROV infection (2020) who will be recontacted for follow-up sampling; (2) 50 adults recruited prospectively from a village with ∼80% seroprevalence, aiming to include at least 20 seropositive individuals for robust analysis of antigen-specific B and T cell responses; and (3) an exploratory cohort of 1 to 10 newly confirmed OROV cases identified during the study period in the Cayenne region, enrolled during the convalescent phase (≥1 month post-diagnosis) to complement the immunological analyses conducted in the first two populations.

A 20 ml blood sample is collected, along with data collection (mainly health data), at the time of enrollment.

The study involves: (1) confirming past OROV infection by detecting OROV-specific polyclonal antibodies in plasma; and (2) characterizing OROV-specific B and T cell responses. Key methodological steps include: isolation of OROV-specific B cells by flow cytometry followed by single-cell culture and stimulation to generate human monoclonal antibodies; screening of secreted mAbs against OROV antigens combined with VDJ sequencing to characterize immunoglobulin repertoires; and structural characterization of neutralizing mAbs using cryo-electron microscopy and nano-imaging to identify conserved epitopes.

02

Conditions studied

  • Oropouche Infection

Keywords

  • Oropouche virus
  • Adaptative Immune Response
  • B cells
  • Monoclonal antibody discovery
03

In context

Lead sponsor

Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

The study population lives in French Guiana in 3 different areas (Saül, Trois Sauts, and Cayenne and its surroundings), and eligible individuals (Populations 1 and 3) or those residing in a high-seroprevalence geographic area (Population 2) were identified by the National Reference Center (CNR) for Arboviruses at the Institut Pasteur of French Guiana (IPG) as part of arbovirus virological surveillance in French Guiana.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For all:

  • Adults (≥18 years old)
  • Willingness to participate in the study after explanation and signing of the form

Study population 1:

- Presenting a laboratory-confirmed OROV infection, defined by a positive real-time RT-PCR and/or positive seroneutralization performed as part of the management of and response to the 2020 OROV epidemic in Saül.

Study population 2:

- Residing in Trois-Sauts for at least 5 years

Study population 3:

- Presenting a laboratory-confirmed OROV infection, defined by a positive real-time RT-PCR and/or positive seroneutralization, identified in the Cayenne area and surrounding localities during the study period, as part of the surveillance activities of the CNR for Arboviruses (IPG).

Exclusion criteria

Exclusion Criteria:

For all:

  • Pregnant women.
  • Individuals presenting with severe chronic pathologies (notably active cancer, primary or secondary immunodeficiency, treatment, infection, or diseases), according to the information declared by the participants.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
80 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • adults with confirmed past OROV infection (2020) recruited from Saül

    Other: 20 ml blood sample

  • adults recruited from Trois-Sauts with ∼80% seroprevalence

    Other: 20 ml blood sample

  • newly confirmed OROV cases identified during the study period in the Cayenne region

    Other: 20 ml blood sample

Interventions

  • Other20 ml blood sample

    A 20-ml blood sample

06

What researchers measure

Primary outcomes

  1. Characterization of the adaptive immune response to OROV infection during the convalescent phase.

    OROV-specific polyclonal antibodies will be detected in participants' plasma to confirm prior infection.

    Time frame: 12 months

Secondary outcomes

  1. Isolate OROV-specific B cells (recognizing the Gn_Gc antigenic complex) and generate human monoclonal antibodies by single B cell culture.

    Isolation of OROV-specific B cells by flow cytometry, followed by culture and stimulation of single B cells to generate and identify human monoclonal antibodies specific to OROV.

    Time frame: 12 months

  2. Screening of secreted mAbs using OROV antigens and VDJ sequencing to characterize immunoglobulin repertoires.

    secreted mAbs using OROV antigens and VDJ sequencing will be screened to characterize immunoglobulin repertoires.

    Time frame: 12 months

  3. Structural characterization of neutralizing mAbs by cryo-EM and nano-imaging to identify conserved epitopes.

    cryo-EM and nano-imaging will be performed on neutralizing mAbs to characterize structurally the mAbs

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
Dec 30, 2027
CompletionEst.
Dec 30, 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07921641
Lead sponsor
Institut Pasteur
Collaborators
CHU Guyane, Institut Pasteur du Cambodge
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Nov 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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