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)

NCT04597424 | Completed Phase 3 DMC

• 1 other identifier: ANRS 174 DOXYVAC
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Unsafe Sex; Risk-Taking

Keywords

STI infection; PREVENTION

Outcome Measures

Primary Outcomes (2)

• For intervention 1 (with or without doxycycline PEP) : 1st occurence of chlamydia or syphilis after the enrolment visit (Day 0)

  Intervention 1 (with or without doxycycline PEP) is the first episode of chlamydia or syphilis after the enrolment visit (Day 0) (chlamydia and syphilis diagnosed at the enrolment visit will not be included in the primary endpoint). Chlamydia détection will be performed by polymerase chain reaction.Syphilis détection will be performed by antigen.

  Month 24

• For intervention 2 with or without Bexsero® vaccine : 1st occurence of gonorrhea reported one month after the second vaccine injection

  Intervention 2 (with or without Bexsero® vaccine) is the first episode of gonorrhea reported one month after the second vaccine injection, so starting at the month 3 visit (gonorrhea episodes diagnosed at the enrolment visit and before the month 3 visit will not be included in the primary endpoint). In these analyses, subject follow-up will be right-censored at the time of the first STI. Gonorrhea détection will be performed by polymerase chain reaction.

  Month 24

Secondary Outcomes (15)

• - Occurrence of a first episode of each of the bacterial STIs as well as cumulative incidence of each bacterial STIs

  Month 2, Month 3, Month 6, Month 12, Month 18, Month 21, Month 24

• - Occurrence of a new episode of anal or urinary gonorrhoea.

  Month 2, Month 3, Month 6, Month 12, Month 18, Month 21, Month 24

• - Occurrence of a first symptomatic episode of chlamydia infection or gonorrhea

  Month 2, Month 3, Month 6, Month 12, Month 18, Month 21, Month 24

• - Proportion of patient with Methicillin-Resistant Staphylococcus Aureus and/or doxycycline resistant Staphylococcus aureus from throat. Fecal carriage of Extended-Spectrum Beta-Lactamase-producing Enterobacteriaceae Composition of intestinal microbiota

  Month 2, Month 3, Month 6, Month 12, Month 18, Month 21, Month 24

• - Incidence of clinical and biological adverse events

  Month 2, Month 3, Month 6, Month 12, Month 18, Month 21, Month 24

Study Arms (4)

doxycycline and Bexsero® vaccine

EXPERIMENTAL

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

Drug: Experimental: doxycycline; Biological: Bexsero® vaccine

doxycycline

EXPERIMENTAL

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

Drug: Experimental: doxycycline

Bexsero® vaccine

EXPERIMENTAL

-Meningococcal B vaccine (Bexsero®) at D0 and M2

Biological: Bexsero® vaccine

No treatment

NO INTERVENTION

-no doxycycline and no Bexsero® vaccine

Interventions

Experimental: doxycycline 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.

doxycycline; doxycycline and Bexsero® vaccine

Bexsero® vaccine BIOLOGICAL

1st injection of Bexsero® vaccine at inclusion visit, 2nd injection at week 8.

Bexsero® vaccine; doxycycline and Bexsero® vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Any condition (clinical) that, in the investigator's opinion, would contraindicate intramuscular vaccination and blood sampling.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (9)

Hôpital Bichat

Paris, 75000, France

Location

Hôpital Hôtel Dieu

Paris, 75181, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

Hôpital Saint-Antoine

Paris, 75571, France

Location

Hôpital pitié Salpetrière

Paris, 75651, France

Location

Hôpital Pitié-Salpétrière

Paris, 75651, France

Location

Hôpital Necker-Enfants Malades

Paris, 75743, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

Hôpital Tenon

Paris, 75970, France

Location

Related Publications (1)

• Molina JM, Bercot B, Assoumou L, Rubenstein E, Algarte-Genin M, Pialoux G, Katlama C, Surgers L, Bebear C, Dupin N, Ouattara M, Slama L, Pavie J, Duvivier C, Loze B, Goldwirt L, Gibowski S, Ollivier M, Ghosn J, Costagliola D; ANRS 174 DOXYVAC Study Group. Doxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a multicentre, open-label, randomised trial with a 2 x 2 factorial design. Lancet Infect Dis. 2024 Oct;24(10):1093-1104. doi: 10.1016/S1473-3099(24)00236-6. Epub 2024 May 23.

  PMID: 38797183 DERIVED

MeSH Terms

Conditions

Unsafe Sex; Risk-Taking

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 22, 2020
• Study Start: January 19, 2021
• Primary Completion: February 19, 2023
• Study Completion: April 19, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

FR (9)