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Isle of Hope, GA, United States

Edupuganti S.,Hope Clinic of the Emory Vaccine Center | Eidex R.B.,Centers for Disease Control and Prevention | Keyserling H.,Emory Childrens Center | Akondy R.S.,Emory Vaccine Center | And 9 more authors.
American Journal of Tropical Medicine and Hygiene | Year: 2013

We evaluated whether coadministration of the yellow fever (YF) virus vaccine with human immunoglobulin (Ig) that contained YF virus-neutralizing antibodies would reduce post-vaccination viremia without compromising immunogenicity and thus, potentially mitigate YF vaccine-associated adverse events. We randomized 80 participants to receive either YF vaccine and Ig or YF vaccine and saline placebo. Participants were followed for 91 days for safety and assessments of viremia and immunogenicity. There were no differences found between the two groups in the proportion of vaccinated participants who developed viremia, seroconversion, cluster of differentiation (CD)-8+ and CD4+ T-cell responses, and cytokine responses. These results argue against one putative explanation for the increased reporting of YF vaccine side effects in recent years (i.e., a change in travel clinic practice after 1996 when hepatitis A prophylaxis with vaccine replaced routine use of pre-travel Ig, thus potentially removing an incidental YF vaccineattenuating effect of anti-YF virus antibodies present in Ig) (Clinical Trials.gov identifier: NCT00254826). Copyright © 2013 by The American Society of Tropical Medicine and Hygiene.

Bernstein D.I.,University of Cincinnati | Jackson L.,Group Health Research Institute | Patel S.M.,Baylor College of Medicine | Sahly H.M.E.,Baylor College of Medicine | And 5 more authors.
Vaccine | Year: 2014

BackgroundStrategies to implement post exposure prophylaxis (PEP) in case of an anthrax bioterror event are needed. To increase the number of doses of vaccine available we evaluated reducing the amount of vaccine administered at each of the vaccinations, and reducing the number of doses administered. MethodsHealthy male and non-pregnant female subjects between the ages of 18 and 65 were enrolled and randomized 1:1:1:1 to one of four study arms to receive 0.5. mL (standard dose) of vaccine subcutaneously (SQ) at: (A) days 0, 14; (B) days 0 and 28; (C) days 0, 14, and 28; or (D) 0.25. mL at days 0, 14, and 28. A booster was provided on day 180. Safety was assessed after each dose. Blood was obtained on days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84, 100, 180, and 201 and both Toxin Neutralizing antibody and anti-PA IgG antibody measured. ResultsAlmost all subjects developed some local reactions with 46-64% reported to be of moderate severity and 3.3% severe during the primary series. Vaccine groups that included a day 14 dose induced a ≥4 fold antibody rise in more subjects on days 21, 28, and 35 than the arm without a day 14 dose. However, schedules with a full day 28 dose induced higher peak levels of antibody that persisted longer. The half dose regimen did not induce antibody as well as the full dose study arms. ConclusionDepending on the extent of the outbreak, effectiveness of antibiotics and availability of vaccine, the full dose 0, 28 or 0, 14, 28 schedules may have advantages. © 2014 Elsevier Ltd.

Keitel W.A.,Baylor College of Medicine | Jackson L.A.,Group Health Research Institute | Edupuganti S.,Hope Clinic of the Emory Vaccine Center | Edupuganti S.,Emory University | And 15 more authors.
Journal of Infectious Diseases | Year: 2015

Background. Variant influenza A(H3N2) viruses (H3N2v) have transmitted recently from pigs to humans in the United States. Vaccines strategies are needed. Methods. Healthy adults received 2 doses of subvirion H3N2v vaccine (15 μg of hemagglutinin/dose) 21 days apart in this open-label trial. Serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody (Ab) titers were measured before and 8 and 21 days after each dose. Memory B-cell (MBC) responses were assessed. Results. Vaccine was well tolerated. A total of 40% of subjects had an HAI Ab titer of ≥40 before vaccination. Eight-seven percent (95% confidence interval [CI], 79%-93%) and 73% (95% CI, 63%-81%) of subjects 18-64 years old (98 subjects) and ≥65 years old (90 subjects), respectively, had an HAI titer of ≥40 21 days after dose 1 (P =. 01); 51% (95% CI, 41%-61%) and 52% (95% CI, 41%-62%) of younger and older subjects, respectively, developed ≥4-fold rises in titer (P = not significant). Neut Ab response patterns were similar. Geometric mean titers were higher in younger subjects. Dose 2 provided no significant enhancement in responses. Cross-reactive MBCs were detected before vaccination and expanded after vaccination. Preexisting H3N2v-specific MBCs positively correlated with early increases in vaccine-induced Ab. Conclusions. In most healthy adults, one 15-μg dose of vaccine elicited levels of HAI Abs associated with protection. Studies in children and elderly individuals are indicated to define the immunization needs of these groups. © 2015 The Author.

Hixson B.A.,Hope Clinic of the Emory Vaccine Center | Hixson B.A.,Emory University | Omer S.B.,Emory University | Del Rio C.,Hope Clinic of the Emory Vaccine Center | And 3 more authors.
Journal of Urban Health | Year: 2011

We assessed prevalent HIV cases in Atlanta to examine case distribution trends and population characteristics at the census tract level that may be associated with clustering effects. We calculated cluster characteristics (area and internal HIV prevalence) via Kuldorffs spatial scan method. Subsequent logistic regression analyses were performed to analyze sociodemographics associated with inclusion in a cluster. Organizations offering voluntary HIV testing and counseling services were identified and we assessed average travel time to access these services. One large cluster centralized in downtown Atlanta was identified that contains 60% of prevalent HIV cases. The prevalence rate within the cluster was 1.34% compared to 0.32% outside the cluster. Clustered tracts were associated with higher levels of poverty (OR=1.19), lower density of multi-racial residents (OR=1.85), injection drug use (OR=1.99), men having sex with men (OR=3.01), and men having sex with men and IV drug use (OR=1.6). Forty-two percent (N=11) of identified HIV service providers in Atlanta are located in the cluster with an average travel time of 13 minutes via car to access these services (SD=9.24). The HIV epidemic in Atlanta is concentrated in one large cluster characterized by poverty, men who have sex with men (MSM), and IV drug usage. Prevention efforts targeted to the population living in this area as well as efforts to address the specific needs of these populations may be most beneficial in curtailing the epidemic within the identified cluster. © 2011 The New York Academy of Medicine.

Frew P.M.,Emory University | Frew P.M.,Emory Center for Research | Frew P.M.,Hope Clinic of the Emory Vaccine Center | Hou S.-I.,University of Georgia | And 8 more authors.
Journal of Clinical Epidemiology | Year: 2010

Objective: We developed the Clinical Research Involvement Scales (CRIS) to assess the willingness to participate in a clinical trial. Study Design and Setting: Diverse populations (N=919) aged 18 years or older from Atlanta, Georgia, were included in comprehensive testing of the 41-item CRIS instrument. The formative phase focused on item content for the new measures (n=54). Questionnaires from potential vaccine trial participants (n=865), collected at multiple time points, resulted in the evaluation of scale reliability and validity (i.e., attitudes, behavioral and normative beliefs, perceived social support for clinical research participation, social norm compliance, perceptions of the clinical research organization, and perceived relevance of the research endeavor). Results: Qualitative testing revealed adequate comprehension and content validity of the initial item set. The subjective norms domain (n=3) initially exhibited poor internal consistency in pilot testing (Cronbach's α=0.525); yet, rewording of the items resulted in consistently stable measurement improvement (Cronbach's α=0.850). Each of the CRIS subscales demonstrated extremely high reliability, ranging from 0.734 to 0.918. Confirmatory factor analysis verified itemefactor relationships and determined construct and convergent validity (root mean square error of approximation =0.068; comparative fit index=0.835). Conclusions: CRIS is a reliable instrument for measuring community attitudes toward participation in biomedical research studies. Results of this study support the use of these scales to recruit diverse populations to clinical trials. © 2010 Elsevier Inc. All rights reserved.

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