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) (DOXYVAC)

ANRS, Emerging Infectious Diseases

Status and phase

Completed

Phase 3

Conditions

Risk-Taking

Unsafe Sex

Treatments

Biological: Bexsero® vaccine

Drug: Experimental: doxycycline

Study type

Interventional

Funder types

Other

Identifiers

NCT04597424

ANRS 174 DOXYVAC

Details and patient eligibility

About

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.

Full description

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".

Enrollment

556 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

556 participants in 4 patient groups

doxycycline and Bexsero® vaccine

Experimental group

Description:

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

Treatment:

Drug: Experimental: doxycycline

Biological: Bexsero® vaccine

doxycycline

Experimental group

Description:

-doxycycline will be taken by participants as PEP (prophylaxy post exposition)

Treatment:

Drug: Experimental: doxycycline

Bexsero® vaccine

Experimental group

Description: