Vaccine
-
Randomized Controlled Trial
Safety and immunogenicity of a respiratory syncytial virus fusion glycoprotein F subunit vaccine in healthy adults: Results of a phase 1, randomized, observer-blind, controlled, dosage-escalation study.
Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infections in infants. An investigational vaccine using an engineered recombinant RSV fusion glycoprotein in its post-fusion conformation (RSV F subunit vaccine) has been developed to protect young infants via maternal immunization. This first-in-human, phase I, observer-blind study (NCT02298179) evaluated the safety and immunogenicity of different dosages and formulations of RSV F subunit vaccine in healthy non-pregnant women and men aged 18-45 years. ⋯ A single dose of each formulation of RSV subunit F vaccine was well-tolerated and enhanced preexisting NAb titers through six months of follow-up.
-
Although major reductions in maternal and child mortality were achieved in the Millennium Development Goals era, progress must be accelerated to meet Sustainable Development Goals health targets by 2030. An estimated 2.7 million neonatal deaths and 2.6 million stillbirths still occur annually. Over the past several years there has been renewed global interest in innovative approaches to maternal immunization to potentially decrease mortality and severe morbidity in neonates, and in the pregnant woman and her fetus. ⋯ Meeting participants identified priority actions including (1) establishing background rates to better evaluate emerging safety signals and vaccine effectiveness, (2) identifying potential sentinel vaccine surveillance sites, (3) developing data sharing capabilities, (4) creating guidance documents and protocols, and (5) the advanced preparation of culturally-appropriate communication plans and risk management plans. Integrating MIV across the routine obstetric and neonatal health care delivery continuum and all relevant programs and data systems could result in fundamental improvements in maternal, neonatal and child health. Improved pregnancy pharmacovigilance platforms may strengthen other vaccine and drug product safety systems and improve maternal and child research capabilities in LMICs.
-
Persons who inject drugs (PWID) are at highest risk for acquiring and transmitting hepatitis C (HCV) infection. The recent availability of oral direct-acting antiviral (DAA) therapy with reported cure rates >90% can prevent HCV transmission, making HCV elimination an attainable goal among PWID. The World Health Organization (WHO) recently proposed a 90% reduction in HCV incidence as a key objective. However, given barriers to the use of DAAs in PWID, including cost, restricted access to DAAs, and risk of reinfection, combination strategies including the availability of effective vaccines are needed to eradicate HCV as a public health threat. This study aims to model the cost and efficacy of a dual modality approach using HCV vaccines combined with DAAs to reduce HCV incidence by 90% and prevalence by 50% in PWID populations. ⋯ The modeling results underscore the importance of developing an effective HCV vaccine and augmenting DAAs with vaccines in HCV intervention strategies in order to achieve efficient reductions in incidence and prevalence.
-
Randomized Controlled Trial
Durability of the neutralizing antibody response to vaccine and non-vaccine HPV types 7 years following immunization with either Cervarix® or Gardasil® vaccine.
Bivalent (Cervarix®) and quadrivalent (Gardasil®) Human Papillomavirus (HPV) vaccines demonstrate remarkable efficacy against the targeted genotypes, HPV16 and HPV18, but also a degree of cross-protection against non-vaccine incorporated genotypes, HPV31 and HPV45. These outcomes seem to be supported by observations that the HPV vaccines induce high titer neutralizing antibodies against vaccine types and lower responses against non-vaccine types. Few data are available on the robustness of the immune response against non-vaccine types. ⋯ The antibody decline rates in those with an initial response to non-vaccine types were similar to that of vaccine types and are predicted to remain detectable for many years. Empirical data on the breadth, magnitude, specificity and durability of the immune response elicited by the HPV vaccines contribute to improving the evidence base supporting this important public health intervention. Original trial: ClinicalTrials.gov NCT00956553.
-
Measles elimination depends on the successful deployment of measles containing vaccine. Vaccination programs often depend on a combination of routine and non-routine services, including supplementary immunization activities (SIAs) and vaccination weeks (VWs), that both aim to vaccinate all eligible children regardless of vaccination history or natural infection. Madagascar has used a combination of these activities to improve measles coverage. However, ongoing massive measles outbreak suggests that the country was in a "honeymoon" period and that coverage achieved needs to be re-evaluated. Although healthcare access is expected to vary seasonally in low resources settings, little evidence exists to quantify temporal fluctuations in routine vaccination, and interactions with other immunization activities. ⋯ Wellcome Trust Fund, Burroughs Wellcome Fund, Gates Foundation, National Institutes of Health.