Last data update: Apr 22, 2024. (Total: 46599 publications since 2009)
Records 1-5 (of 5 Records) |
Query Trace: Abarbanell G [original query] |
---|
Safety, immunogenicity and efficacy of PfSPZ vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial
Oneko M , Steinhardt LC , Yego R , Wiegand RE , Swanson PA , Kc N , Akach D , Sang T , Gutman JR , Nzuu EL , Dungani A , Kim Lee Sim B , Oloo PN , Otieno K , Bii DK , Billingsley PF , James ER , Kariuki S , Samuels AM , Jongo S , Chebore W , Abdulla S , Daubenberger C , Mpina M , Styers D , Potter GE , Abarbanell G , Richie TL , Hoffman SL , Seder RA . Nat Med 2021 27 (9) 1636-1645 The radiation-attenuated Plasmodium falciparum sporozoite (PfSPZ) vaccine provides protection against P. falciparum infection in malaria-naïve adults. Preclinical studies show that T cell-mediated immunity is required for protection and is readily induced in humans after vaccination. However, previous malaria exposure can limit immune responses and vaccine efficacy (VE) in adults. We hypothesized that infants with less previous exposure to malaria would have improved immunity and protection. We conducted a multi-arm, randomized, double-blind, placebo-controlled trial in 336 infants aged 5-12 months to determine the safety, tolerability, immunogenicity and efficacy of the PfSPZ Vaccine in infants in a high-transmission malaria setting in western Kenya ( NCT02687373 ). Groups of 84 infants each received 4.5 × 10(5), 9.0 × 10(5) or 1.8 × 10(6) PfSPZ Vaccine or saline three times at 8-week intervals. The vaccine was well tolerated; 52 (20.6%) children in the vaccine groups and 20 (23.8%) in the placebo group experienced related solicited adverse events (AEs) within 28 d postvaccination and most were mild. There was 1 grade 3-related solicited AE in the vaccine group (0.4%) and 2 in the placebo group (2.4%). Seizures were more common in the highest-dose group (14.3%) compared to 6.0% of controls, with most being attributed to malaria. There was no significant protection against P. falciparum infection in any dose group at 6 months (VE in the 9.0 × 10(5) dose group = -6.5%, P = 0.598, the primary statistical end point of the study). VE against clinical malaria 3 months after the last dose in the highest-dose group was 45.8% (P = 0.027), an exploratory end point. There was a dose-dependent increase in antibody responses that correlated with VE at 6 months in the lowest- and highest-dose groups. T cell responses were undetectable across all dose groups. Detection of Vδ2(+)Vγ9(+) T cells, which have been correlated with induction of PfSPZ Vaccine T cell immunity and protection in adults, were infrequent. These data suggest that PfSPZ Vaccine-induced T cell immunity is age-dependent and may be influenced by Vδ2(+)Vγ9(+) T cell frequency. Since there was no significant VE at 6 months in these infants, these vaccine regimens will likely not be pursued further in this age group. |
Contraceptive methods of privately insured US women with congenital heart defects
Anderson KN , Tepper NK , Downing K , Ailes EC , Abarbanell G , Farr SL . Am Heart J 2020 222 38-45 BACKGROUND: The American Heart Association recommends women with congenital heart defects (CHD) receive contraceptive counseling early in their reproductive years, but little is known about contraceptive method use among women with CHD. We describe recent female sterilization and reversible prescription contraceptive method use by presence of CHD and CHD severity in 2014. METHODS: Using IBM MarketScan Commercial Databases, we included women aged 15 to 44 years with prescription drug coverage in 2014 who were enrolled >/=11 months annually in employer-sponsored health plans between 2011 and 2014. CHD, CHD severity, contraceptive methods, and obstetrics-gynecology and cardiology provider encounters were identified using billing codes. We used log-binomial regression to calculate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs) to compare contraceptive method use overall and by effectiveness tier by CHD presence and, for women with CHD, severity. RESULTS: Recent sterilization or current reversible prescription contraceptive method use varied slightly among women with (39.2%) and without (37.3%) CHD, aPR=1.04, 95% CI [1.01-1.07]. Women with CHD were more likely to use any Tier I method (12.9%) than women without CHD (9.3%), aPR=1.41, 95% CI [1.33-1.50]. Women with severe, compared to non-severe, CHD were less likely to use any method, aPR=0.85, 95% CI [0.78-0.92], or Tier I method, aPR=0.84, 95% CI [0.70-0.99]. Approximately 60% of women with obstetrics-gynecology and <40% with cardiology encounters used any included method. CONCLUSIONS: There may be missed opportunities for providers to improve uptake of safe, effective contraceptive methods for women with CHD who wish to avoid pregnancy. |
Safety, tolerability, and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation to infants and young children: findings from an age de-escalation, dose-escalation double-blinded randomized, controlled study in western Kenya
Steinhardt LC , Richie TL , Yego R , Akach D , Hamel MJ , Gutman JR , Wiegand RE , Nzuu EL , Dungani A , Kc N , Murshedkar T , Church LWP , Sim BKL , Billingsley PF , James ER , Abebe Y , Kariuki S , Samuels AM , Otieno K , Sang T , Kachur SP , Styers D , Schlessman K , Abarbanell G , Hoffman SL , Seder RA , Oneko M . Clin Infect Dis 2019 71 (4) 1063-1071 BACKGROUND: The whole sporozoite PfSPZ Vaccine is being evaluated for malaria prevention. The vaccine is administered intravenously for maximal efficacy. Direct venous inoculation (DVI) with PfSPZ Vaccine has been safe, tolerable, and feasible in adults, but safety data for children and infants are limited. METHODS: We conducted an age de-escalation, dose-escalation randomized controlled trial in Siaya County, western Kenya. Children and infants (5-9 years, 13-59 months, and 5-12 months) were enrolled into 13 age-dose cohorts of 12 participants and randomized 2:1 to vaccine or normal saline placebo in escalating doses: 1.35x105, 2.7x105, 4.5x105, 9.0x105, and 1.8x106Plasmodium falciparum sporozoites (PfSPZ), with the two highest doses given twice, 8 weeks apart. Solicited adverse events (AEs) were monitored for eight days after vaccination; unsolicited AEs for 29 days; and serious AEs (SAEs) throughout the study. Blood taken pre-vaccination and one-week post-vaccination was tested for IgG antibodies to Pf circumsporozoite protein (PfCSP) using enzyme-linked immunosorbent assay (ELISA). RESULTS: Rates of AEs were similar in vaccinees and controls for solicited (35.7% vs. 41.5%) and unsolicited (83.9% vs. 92.5%) AEs, respectively. No related grade 3 AEs, SAEs, or grade 3 laboratory abnormalities occurred. Most (79.0%) vaccinations were administered by a single DVI. Among those in the 9.0x105 and 1.8x106 PfSPZ groups, 36/45 (80.0%) vaccinees and 4/21 (19.0%) placebo controls developed antibodies to PfCSP, p<0.001. CONCLUSIONS: PfSPZ Vaccine in doses as high as 1.8x106 can be administered to infants and children by DVI, and was safe, well tolerated, and immunogenic. |
Safety of contraceptive use among women with congenital heart disease: A systematic review
Abarbanell G , Tepper NK , Farr SL . Congenit Heart Dis 2019 14 (3) 331-340 OBJECTIVE: Women with congenital heart disease (CHD) are at increased risk of pregnancy complications and need information on safe, effective contraceptive methods to avoid unintended pregnancy. This systematic review examines evidence regarding safety of contraceptive use among women with CHD. METHODS: The PubMed database was searched for any peer-reviewed articles published through April 2018 that included safety outcomes associated with reversible contraceptive methods among women with CHD. RESULTS: Five articles met inclusion criteria: three studies comparing contraceptive users to nonusers and two noncomparative studies. Sample sizes ranged from 65 to 505 women with CHD. Two studies found a higher percent of thromboembolic complications among women with Fontan palliation or transposition of the great arteries using oral contraceptives. One study, among women with Fontan palliation, found no increased risk of thromboembolic complications between contraceptive users (not separated by type) and nonusers. Two studies found no endocarditis among intrauterine device users. CONCLUSIONS: There is a paucity of data regarding the safety of contraceptive methods among women with CHD. Limited evidence suggests an increased incidence of thromboembolic complications with use of oral contraceptives. Further studies are needed to evaluate contraceptive safety and quantify risk in this growing population. There is also limited data regarding the safety of contraceptive methods among women with CHD. Further information is needed to assist practitioners counseling women with CHD on safety of contraceptive methods. |
Functional limitations and educational needs among children and adolescents with heart disease
Farr SL , Downing KF , Riehle-Colarusso T , Abarbanell G . Congenit Heart Dis 2018 13 (4) 633-639 OBJECTIVE: To examine how cognitive and motor limitations in children with heart disease are associated with education and participation in extracurricular activities. DESIGN: Using 2009-2010 parent-reported data from the National Survey of Children with Special Health Care Needs (NS-CSHCN), we examined prevalence of five functional limitations (learning/concentration, communication, self-care, gross motor skills, and fine motor skills) by diagnosed heart disease status using chi-square tests and multivariable logistic regression. Among CSHCN with heart disease, we examined the associations between severity of each functional limitation and missing >/=11 days of school in the past year, receiving special education services, and interference with extracurricular activities. RESULTS: CSHCN with heart disease (n = 1,416), compared to CSHCN without (n = 28,385), more commonly had "a lot" of difficulty in the five functional areas (P < .01; adjusted odds ratios: 1.8-3.3). Among CSHCN with heart disease, "a lot" of difficulty with learning/concentration was most common (35%), followed by communication (21%), self-care (14%), gross motor skills (12%), and fine motor skills (10%). Among CSHCN with heart disease, compared to those without, respectively, 27% and 15% missed >/=11 days of school, 45% and 29% received special education services, and 49% and 29% experienced interference with extracurricular activities (P < .01 for all). Level of difficulty with the five functional areas was associated with receipt of special education services and participation in extracurricular activities (P < .001). CONCLUSION: These results support the American Heart Association recommendations to screen children with congenital heart disease for age-appropriate development and provide services when needed. |
- Page last reviewed:Feb 1, 2024
- Page last updated:Apr 22, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure