ANRS 174 DOXYVAC (4CMenB vaccine)
Trial question
What is the role of meningococcal group B vaccine in MSM?
Study design
Multi-center
Open label
RCT
Population
544 male patients.
Inclusion criteria: adult MSM, HIV-negative, with a history of bacterial STIs within the past 12 months.
Key exclusion criteria: previous meningococcal group B vaccination; current treatment with doxycycline; doxycycline allergy or other contraindication for use.
Interventions
N=274 4CMenB vaccine (two IM injections of meningococcal group B vaccine 2 months apart at enrolment and at 2 months after randomization).
N=270 no vaccine (no meningococcal group B vaccine).
Primary outcome
Incidence of first episode of gonorrhea starting at 3 months
58.3
77.1
77.1/100 py
57.8/100 py
38.5/100 py
19.3/100 py
0.0/100 py
4CMenB
vaccine
No
vaccine
No significant
difference ↔
No significant difference in the incidence of first episode of gonorrhea starting at 3 months (58.3/100 py vs. 77.1/100 py; HR 0.78, 95% CI 0.6 to 1.01).
Secondary outcomes
No significant difference in the incidence of first episode of rectal gonorrhea (29.7/100 py vs. 33.1/100 py; HR 0.9, 95% CI 0.64 to 1.28).
No significant difference in the incidence of first episode of culture-positive gonorrhea (14.7/100 py vs. 15.8/100 py; HR 0.95, 95% CI 0.55 to 1.65).
No significant difference in the incidence of cumulative incidence of gonorrhea (52.6/100 py vs. 62.4/100 py; IRR 0.84, 95% CI 0.67 to 1.07).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult MSM, HIV-negative, with a history of bacterial STIs within the past 12 months, 4CMenB vaccine was not superior to no vaccine with respect to the incidence of first episode of gonorrhea starting at 3 months.
Reference
Jean-Michel Molina, Beatrice Bercot, Lambert Assoumou et al. 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 × 2 factorial design. Lancet Infect Dis. 2024 Oct;24(10):1093-1104.
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