Can a pill and a vaccine stop STIs in High-Risk men?
NCT ID NCT04597424
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two strategies to prevent sexually transmitted infections (STIs) in men who have sex with men and already take HIV PrEP. One group took doxycycline pills after unprotected sex, and another group received a meningitis vaccine (Bexsero). The goal was to see if these approaches could reduce new cases of chlamydia, syphilis, and gonorrhea. Over 550 men took part in this completed Phase 3 trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- doxycycline and Bexsero® vaccine
- What this could lead to
- If it works, this could offer a new way to prevent bacterial STIs in high-risk groups, reducing infections like chlamydia, syphilis, and gonorrhea.
- What could go wrong
- This is a completed Phase 3 trial, but results may not apply to all populations. Doxycycline overuse could lead to antibiotic resistance, and the vaccine may not protect against all gonorrhea strains.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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556 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Apr 2024
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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). * HIV infection. * Previous vaccination with Bexsero® or any other meningococcal B vaccine. * Vaccination during the 4 weeks (28 days) preceding the first vaccination of the study. * 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. * 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. * Documented oesophageal lesion * 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. * Any condition (clinical) that, in the investigator's opinion, would contraindicate intramuscular vaccination and blood sampling. * Oral Anticoagulant treatment. * Continuous treatment with doxycycline at inclusion. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Bichat
Paris, 75000, France
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Hôpital Européen Georges Pompidou
Paris, 75908, France
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Hôpital Hôtel Dieu
Paris, 75181, France
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Hôpital Necker-Enfants Malades
Paris, 75743, France
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Hôpital Pitié-Salpétrière
Paris, 75651, France
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Hôpital Saint-Antoine
Paris, 75571, France
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Hôpital Saint-Louis
Paris, 75475, France
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Hôpital Tenon
Paris, 75970, France
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Hôpital pitié Salpetrière
Paris, 75651, France
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