RESUMO
BACKGROUND: In a phase 1/2 study, a maternal respiratory syncytial virus vaccine candidate (RSVPreF3) demonstrated an acceptable safety profile and efficiently increased RSV-specific humoral immune responses in non-pregnant women. METHODS: In this phase 2 observer-blind, placebo-controlled, randomized clinical trial (NCT04126213), the safety of RSVPreF3 (60 or 120 µg), administered during late second or third trimester, was evaluated in 213 18- to 40-year-old healthy pregnant women through 6 months postdelivery and their offspring through infancy; immunogenicity was evaluated through day 43 postdelivery and day 181 postbirth, respectively. RESULTS: RSVPreF3 was well tolerated. No pregnancy-related or neonatal adverse events of special interest were considered vaccine/placebo related. In the 60 and 120 µg RSVPreF3 groups: (1) neutralizing antibody (nAb) titers in mothers increased 12.7- and 14.9-fold against RSV-A and 10.6- and 13.2-fold against RSV-B, respectively, 1 month postvaccination and remained 8.9-10.0-fold over prevaccination at day 43 postdelivery; (2) nAb titers were consistently higher compared to placebo recipients; (3) placental transfer ratios for anti-RSVPreF3 antibodies at birth were 1.62 and 1.90, respectively, and (4) nAb levels in infants were highest at birth and declined through day 181 postbirth. CONCLUSIONS: RSVPreF3 maternal vaccination had an acceptable safety risk profile and induced robust RSV-specific immune responses with successful antibody transfer to their newborns. CLINICAL TRIALS REGISTRATION: NCT04126213.
WHAT IS THE CONTEXT?: Infants, especially those less than 6 months of age, are at increased risk of lung infection caused by respiratory syncytial virus (RSV). However, this risk could be reduced with maternal vaccination against RSV during pregnancy. A previous clinical trial found that a vaccine candidate (named RSVPreF3) was well tolerated when given to non-pregnant women. WHAT IS NEW?: In pregnant women, RSVPreF3 was also well tolerated. Occurrence of unsolicited adverse events was similar between vaccine and placebo recipients. None of the serious adverse events or events of interest for pregnant women or newborns were considered related to the study intervention. One month after vaccination, mothers who received RSVPreF3 had 1115 times higher levels of antibodies against RSV than before vaccination. These antibody levels remained similar until 43 days after delivery. In the infants born to mothers vaccinated during pregnancy with RSVPreF3, antibody levels were highest at birth, when levels were higher than in their mothers, and declined through day 181 postbirth. WHAT IS THE IMPACT?: RSVPreF3 had an acceptable safety risk profile in pregnant women and their babies. This vaccine induced potent immune responses against RSV, with maternal antibodies transferred to infants of the vaccinated mothers.
Assuntos
Infecções por Vírus Respiratório Sincicial , Vacinas contra Vírus Sincicial Respiratório , Vírus Sincicial Respiratório Humano , Gravidez , Humanos , Feminino , Lactente , Recém-Nascido , Adolescente , Adulto Jovem , Adulto , Anticorpos Antivirais , Anticorpos Neutralizantes , Mães , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Proteínas Virais de Fusão , Placenta , Imunogenicidade da VacinaRESUMO
Objetivo. Estudiar asociaciones entre tener una actitud negativa hacia la educación sexual a jóvenes, y factores socio-demográficos y conocimientos, actitudes y prácticas sobre salud sexual y reproductiva. Métodos. Se estudiaron 5676 mujeres y 2357 hombres de15 a 49 años con datos de la Encuesta Nacional sobre Salud Sexual y Reproductiva 2009. Se utilizó Chi cuadrado de Pearson y el Test de Wald en STATA/SE 13.1. Las frecuencias relativas se ponderaron por factores de expansión. Resultados. Mas mujeres (17.9%) que hombres (13.4%)no están a favor de la educación sexual a jóvenes (p=0.01), sin embargo, no hay diferencias según sexo en la oposicióna enseñar métodos de planificación familiar (22.7%). Seoponen a la educación sexual principalmente personas sineducación o sólo con educación primaria, pobres extremos, viviendo en áreas indígenas y rurales, pertenecientes apueblos originarios, que apoyan la violencia contra la mujery sin conocimiento comprensivo sobre VIH-SIDA. En los hombres, el no haber tenido relaciones sexuales se relacionacon una actitud negativa hacia la educación sexual a jóvenes, mientras que en las mujeres se relacionan la religión y las actitudes de aceptación de roles tradicionales de género. La edad y el estado civil no influyen en el apoyo a la educación sexual...
Objective. Studying associations between having a negativeattitude towards sex education to young people, and sociodemographic factors and knowledge, attitudes and practices on sexual and reproductive health Methods. Were studied 5676 women and 2357 men aged 15to 49 years using data from the National Survey on Sexual and Reproductive Health 2009. It was used Chi square test and the Wald test with STATA / SE 13.1. The relative frequencies were weighted by expansion factors. Results. More women (17.9%) than men (13.4%) are notin favor of sex education to youth (p = 0.01), however, nodifferences by sex in opposition to teach methods of family planning (22.7%). The opposition to sex education is mainly from uneducated people or only with primary education, living in extreme poverty, living in rural and indigenous areas, belonging to indigenous peoples, who support violence against women, and without comprehensive knowledge aboutHIV-AIDS. In men, not having sex is related to a negative attitude towards sex education to young, while in women religion and the attitudes of acceptance of traditional genderroles are related. Age and marital status did not influence support for sex education...
Assuntos
Humanos , Adolescente , Educação Sexual/métodos , Panamá , Saúde Reprodutiva/educaçãoRESUMO
Objetivo. Identificar los factores que se relacionan a la iniciación sexual a temprana edad en las adolescentes panameñas. Métodos. Se estudiaron 1193 mujeres de 15 a 19 años con datos de la Encuesta Nacional sobre Salud Sexual y Reproductiva de 2009. Se utilizó la regresión de riesgos proporcionales de Cox en SPSS 20. Las frecuencias relativas se ponderaron por factores de expansión...
Objective. To identify the factors that were related to thesexual initiation to early age in the Panamanian adolescents.Methods. 1193 women of 15 to 19 years were studied with dataof the National Survey studied on Sexual and ReproductiveHealth of 2009. The regression of proportional risks of Cox inSPSS 20 was used. The relative frequencies were weighedby expansion factors...
Assuntos
Humanos , Adolescente , Adolescente , Educação Sexual/classificação , Educação Sexual/métodos , Saúde ReprodutivaRESUMO
Objetivo. Identificar los determinantes de las necesidades insatisfechas de planificación familiar en las comarcas n gabe-Buglé y Emberá. Método. Se estudiaron 447 mujeres casadas o unidas y no embarazadas, de 15 a 49 años de las etnias n gabe,Buglé, Emberá y Wounaan, con datos de la Encuesta Nacional de Salud Sexual y Reproductiva 2009...
