000			03272nam a2200301 4500
001			ESSALUD
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040			_aBMG
041			_aeng
100			_aSeib, Kate L. _eAutor _953789
245			_aMeningococcal B vaccine to prevent neisseria gonorrhoeae infection
300			_apáginas: 349-361
520			_aBackground: No vaccines are currently licensed for the prevention of Neisseria gonorrhoeae infection. Observational studies suggest that the four-component meningococcal serogroup B vaccine (4CMenB) may reduce the risk of gonorrhea. Methods: In this multicenter, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, men who have sex with men (MSM) to receive two doses of 4CMenB or placebo. All the participants had recently received a diagnosis of N. gonorrhoeae infection or infectious syphilis and either tested negative for human immunodeficiency virus (HIV) and were receiving HIV preexposure prophylaxis or were living with HIV. Screening for sexually transmitted infections, including N. gonorrhoeae nucleic acid amplification testing of samples obtained from urogenital, anorectal, and oropharyngeal sites, was performed quarterly for 2 years. The primary outcome was a first N. gonorrhoeae infection after the receipt of vaccine or placebo in the per-protocol population (participants who received both 4CMenB or placebo doses, attended at least two scheduled follow-up visits after the second dose, and did not meet any exclusion criterion pertinent to the assessment of efficacy). Results: From July 2021 through May 2023, a total of 654 participants underwent randomization, of whom 587 were included in the primary analysis. The incidence of N. gonorrhoeae infection was 48.1 events per 100 person-years (160 events among 296 participants) in the 4CMenB group and 47.8 events per 100 person-years (155 events among 291 participants) in the placebo group (incidence rate ratio, 1.01; 95% confidence interval [CI], 0.80 to 1.26; P=0.97), for a vaccine efficacy of −0.5% (95% CI, −26.2 to 19.9). Vaccine efficacy was 5.5% (95% CI, −56.0 to 42.8) for symptomatic infection, −6.4% (95% CI, −47.5 to 23.2) for asymptomatic infection, and −20.0% (95% CI, −90.2 to 23.9), −1.2% (95% CI, −33.0 to 23.0), and 2.6% (95% CI, −27.7 to 25.7) for urogenital, anorectal, and oropharyngeal infection, respectively. Serious adverse events occurred in 4.7% of the participants in the 4CMenB group and in 2.8% of those in the placebo group. Conclusions: 4CMenB did not result in a lower incidence of N. gonorrhoeae infection than placebo among MSM who were at high risk for gonorrhea.
650			_aINFECCIONES BACTERIANAS _97357
650			_aSALUD GLOBAL _910472
650			_aVIH/SIDA _953790
650			_aENFERMEDADES INFECCIOSAS _96776
650			_aSALUD PUBLICA _91652
650			_aVACUNAS _98158
700			_aDonovan, Basil _953791
700			_aJin, Fengyi _953792
700			_aThng, Caroline _953793
700			_aYeung, Barbara _953794
700			_aComninos, Nicholas _953795
773	0		_022717 _922637 _dMassachusetts NEJM Group _oNEJM004 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-07-31 _zSQB
999			_c22746 _d22746