NCT04597424CompletedPhase 3
Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 556 (actual)
- First submitted
- 1 Oct 2020
- Start date
- 19 Jan 2021
- Primary completion date
- 19 Feb 2023
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- HIV
- NCT number
- NCT04597424
- EudraCT number
- 2019-002829-29
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 556
- From 19 Jan 2021 to the primary completion date, 19 Feb 2023
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous vaccination with Bexsero® or any other meningococcal B vaccine.
- Previous vaccination with an experimental vaccine in the previous 5 years.
- Systemic treatment with retinoids : isotretinoin (Acnetrait®, Procuta®, Curacné®, Contracné®, …).
- Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin, ….).
- Participant who has received immunoglobulins, a transfusion of blood or blood derivatives in the last 3 months.
- Acute respiratory infection or severe acute febrile illness or systemic reaction that may present a significant risk if vaccinated in the month prior to inclusion.
- Continuous treatment with doxycycline at inclusion.
Other illness
- HIV infection.
- Known or suspected congenital or acquired immunodeficiency; immunosuppressive treatment in the last 6 months, such as cancer chemotherapy or radiotherapy; long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks in the last 3 months)
- Known allergy to antibiotics of the tetracycline family.
- Known allergy to any component of the Bexsero® vaccine.
- Known allergy to any component of the doxycycline pill.
- Known allergy to latex (contained in the vaccine cap).
- Thrombocytopenia or any other known coagulation disorder, which would be a contraindication to an intramuscular injection of Bexsero® vaccine.
- Any condition (clinical) that, in the investigator's opinion, would contraindicate intramuscular vaccination and blood sampling.
Lab values
- Syphilis diagnosed prior to inclusion without serologic evidence of cure (cure is defined as decreased by at least 4-fold of the non-treponemal antibody titer \[Venereal Disease Research Laboratory (VDRL), Rapid Plasma Reagin (RPR)\] relative to the titer at initiation of treatment of syphilis).
Other
- Vaccination during the 4 weeks (28 days) preceding the first vaccination of the study.
- Documented oesophageal lesion
- Oral Anticoagulant treatment.
- Vitamin A treatment in case of intake of 10 000 international unit or more.
- Participation in another research including an exclusion period still in progress at the time of inclusion.
- Under guardianship or curator, or deprived of liberty by a judicial or administrative decision.
Who the study is looking for
- Mens who have sex with mens (MSM) enrolled in the ANRS PREVENIR study.
- At least 6-month experience with PrEP (within the ANRS PREVENIR study or before starting the ANRS PREVENIR study).
- No clinical manifestation of primary HIV infection and no symptom of bacterial STI (chlamydia, gonorrhea, M. genitalium or syphilis).
- History of documented bacterial STI with at least one episode in the last 12 months.
- Participants who agree to sign the information and consent form specific to this study.
- Valid health insurance (State medical aid (AME) is not health insurance).
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Saint-Antoine Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Tenon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Bichat Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Hôtel - Dieu Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.