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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

556 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-19

Study Completion Date

2024-04-19

Brief Summary

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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.

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Detailed Description

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This is a randomized study with a factorial design for the 2 biomedical interventions (interventions 1 and 2).

Subjects will be randomized and assigned to two different interventions:

* Intervention 1: PEP with doxycycline or no PEP. Subjects will be randomized 2/1 to receive doxycycline PEP or no PEP
* Intervention 2: Meningococcal B vaccine (Bexsero®) or no vaccine Subjects will be randomized 1/1 to received 2 doses of Bexsero® vaccine (at the first visit and two months later) or no vaccine

Participants will be randomized in one of the following arms:

* Arm 1: doxycycline and Bexsero® vaccine (240 participants)
* Arm 2: doxycycline and no Bexsero® vaccine (240 participants)
* Arm 3: no doxycycline and Bexsero® vaccine (120 participants)
* Arm 4: no doxycycline and no Bexsero® vaccine (120 participants)

Randomization will be stratified by whether or not the participant enters in the ancillary study "intestinal microbiota".

Conditions

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Unsafe Sex Risk-Taking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1 : doxycycline and Bexsero vaccine Arm 2 : doxycycline and no vaccine Arm 3 : No doxycycline and Bexsero vaccine Arm 3 : No doxycycline and No Bexsero vaccine

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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doxycycline and Bexsero® vaccine

-doxycycline will be taken by participants as PEP (prophylaxy post exposition) and participants will received Meningococcal B vaccine (Bexsero®) at D0 and M2

Group Type EXPERIMENTAL

Experimental: doxycycline

Intervention Type DRUG

2 tablets of doxycycline 100 mg (monohydrate form) will be taken orally after each risk sexual intercourse, ideally within 24 hours after sex and no more than 72 hours. PEP should not be taken more than 3 times over a 7 days' period.

If a participant has risk sexual intercourse for several consecutive days, PEP should be taken at least 48 hours apart and no more than 3 times 2 tablets over 7 days. A maximum of 3 intakes of 2 tablets will be allowed over a period of 7 days.

Bexsero® vaccine

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes