Immunization during pregnancy has been recommended in an increasing number of countries. The aim of this strategy is to protect pregnant women and infants from severe infectious disease, morbidity and mortality and is currently limited to tetanus, inactivated influenza, and pertussis-containing vaccines. There have been recent advancements in the development of vaccines designed primarily for use in pregnant women (respiratory syncytial virus and group B Streptococcus vaccines). Although there is increasing evidence to support vaccination in pregnancy, important gaps in knowledge still exist and need to be addressed by future studies. This collaborative consensus paper provides a review of the current literature on immunization during pregnancy and highlights the gaps in knowledge and a consensus of priorities for future research initiatives, in order to optimize protection for both the mother and the infant.

• Klíčová slova
• group B Streptococcus vaccines, influenza, maternal immunization, pertussis, pregnant women, respiratory syncytial virus, tetanus,
• MeSH
• celosvětové zdraví MeSH
• hodnocení rizik MeSH
• hodnocení vlivů na zdraví MeSH
• imunizace * škodlivé účinky   etika   metody   trendy   MeSH
• imunogenicita vakcíny MeSH
• infekční komplikace v těhotenství epidemiologie   prevence a kontrola   MeSH
• klinické zkoušky jako téma etika   MeSH
• konsensus MeSH
• lékařská etika MeSH
• lidé MeSH
• matka - expozice noxám MeSH
• rizikové faktory MeSH
• těhotenství MeSH
• vakcinace MeSH
• vakcíny aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• výzkum MeSH
• zdravotní priority MeSH
• zpožděný efekt prenatální expozice MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• vakcíny MeSH

IMPORTANCE: Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster. OBJECTIVE: To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. DESIGN, SETTING, AND PARTICIPANTS: Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. INTERVENTIONS: Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. MAIN OUTCOMES AND MEASURES: The primary end point was occurrence of confirmed herpes zoster cases. RESULTS: Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P < .001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P = .02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P = .02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P = .01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points. CONCLUSIONS AND RELEVANCE: Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01610414.

• MeSH
• adjuvancia imunologická MeSH
• autologní transplantace MeSH
• dospělí MeSH
• herpes zoster epidemiologie   prevence a kontrola   MeSH
• hospitalizace statistika a číselné údaje   MeSH
• imunokompromitovaný pacient * MeSH
• incidence MeSH
• injekce intramuskulární MeSH
• jednoduchá slepá metoda MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• postherpetická neuralgie prevence a kontrola   MeSH
• proporcionální rizikové modely MeSH
• syntetické vakcíny aplikace a dávkování   MeSH
• transplantace hematopoetických kmenových buněk * MeSH
• vakcína proti pásovému oparu * aplikace a dávkování   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• adjuvancia imunologická MeSH
• syntetické vakcíny MeSH
• vakcína proti pásovému oparu * MeSH