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Biomedical subjects

Rebecca C Brady

Publications and source records attributed to Rebecca C Brady.

9 recordsLinked to original sources
PubMed2006

Dose-related safety and immunogenicity of a trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine in elderly adults.

BACKGROUND: Influenza-virus hemagglutinin (HA) protein expressed in insect cells by recombinant baculovirus is a candidate influenza vaccine. METHODS: In a randomized, double-blind trial conducted in 399 adults > or = 65 years of age, the efficacy of trivalent inactivated influenza vaccine (TIV) licensed for intramuscular injection was compared with that of trivalent baculovirus-expressed HA vaccine administered at doses of 15 microg, 45 microg, or 135 microg of each HA. RESULTS: Compared with TIV, baculovirus-expressed HA vaccine was safe and induced better serum antibody responses to the H3 component when administered at doses of 45 microg or 135 microg of each HA. CONCLUSIONS: Baculovirus-expressed HA is a safe and immunogenic influenza vaccine in elderly adults.

Adult↗
PubMed2005

Rapid licensure of a new, inactivated influenza vaccine in the United States.

BACKGROUND: The unexpected problems at 1 of 2 US licensed manufacturers of trivalent inactivated influenza virus vaccine (TIV) in 2004 highlights the urgent need for additional vaccine sources. We evaluated a split virus TIV (Fluarix, GSK), to generate data supportive of a license application in the US. METHODS: Healthy adults ages 18-64 years at four centers were randomly assigned to receive a single IM injection of Fluarix (n = 763) or placebo (n = 193) in double-blind fashion. Subjects were monitored for safety and serum hemagglutination-inhibition (HAI) titers determined before and 21 days after vaccination. RESULTS: Vaccine was well tolerated, with only mild to moderate myalgias and injection site pain and redness being more common in vaccine than placebo recipients. Four-fold or greater increases in serum HAI titers were seen in 60%, 62% and 78% of vaccine recipients against the H1, H3, and B components of the vaccine, respectively, and post-vaccination titers of > 1:40 achieved in 98%, 99% and 99% of subjects, exceeding the prespecified criteria for acceptability for all three antigens. CONCLUSIONS: Fluarix has a safety and immunogenicity profile like other US-licensed inactivated influenza vaccines and should be effective when used to immunize US adults. SUMMARY LINE: The results of this study were pivotal for the rapid approval of Fluarix in the US for use in adults 18 years of age or older.

Adolescent↗
PubMed2005

A randomized controlled trial of a replication defective (gH deletion) herpes simplex virus vaccine for the treatment of recurrent genital herpes among immunocompetent subjects.

BACKGROUND: A replication incompetent herpes virus lacking the glycoprotein H gene has been developed as a potential therapeutic vaccine for genital herpes. GOAL: To determine vaccine efficacy on reducing HSV reactivation and clinical disease among immunocompetent persons with recurrent genital HSV-2 infection. STUDY DESIGN: Randomized multicenter placebo-controlled trial. Healthy volunteers who had six or more recurrences of genital herpes per year were randomized to receive injections of vaccine at 0 and 8 or 0, 4, and 8 or 0, 2, 4, and 8 weeks or placebo and were followed for subsequent recurrences for 1 year. RESULTS: The median times to first recurrence of genital herpes (40 days versus 30 days versus 37 days versus 42 days, respectively), mean number of recurrences (3 versus 3 versus 2.4 versus 1.9, respectively), and time to lesion healing of the first recurrence (8 days versus 7.8 days versus 7.4 days versus 7.5 days, respectively), were similar for all treatment groups. Asymptomatic viral shedding was detected by PCR in 61/74 (82%) persons performing daily sample collection following completion of the vaccination series. No differences were noted in the proportion of days with shedding between treatment groups (11.9% versus 17.2% versus 13.1% versus 16.4%, respectively). CONCLUSION: This replication incompetent HSV-2 vaccine lacking the glycoprotein H gene was safe but had no clinical or virologic benefit in the amelioration of genital HSV-2 disease among immunocompetent men and women.

Adolescent↗
PubMed2005

Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine.

BACKGROUND: Rotavirus is a major cause of gastroenteritis in children worldwide and is estimated to be responsible for more than 500,000 physician visits, 50,000 hospitalizations and 20 deaths in the United States each year. OBJECTIVE: To compare the safety and immunogenicity of 2 dosages of a live attenuated oral monovalent G1 human rotavirus (HRV) vaccine in healthy infants. DESIGN/METHODS: In this randomized, double blind trial conducted in the United States and Canada, 529 healthy infants 5-15 weeks of age received HRV vaccine containing either 10 or 10 focus-forming units or placebo. Two doses were administered orally at a 2-month interval concomitantly with routine childhood vaccines. Symptoms of fever, irritability/fussiness, diarrhea, vomiting, loss of appetite and cough/runny nose were solicited for 15 days postvaccination, nonserious adverse events for 43 days postvaccination and serious adverse events throughout the study. Vaccine take was defined as appearance of serum antirotavirus IgA in postimmunization sera at a titer of > or =20 units/mL or vaccine virus shedding in any stool sample collected between the first dose and 2 months after the second dose. RESULTS: No serious adverse events considered related to vaccine were reported. The incidence of solicited symptoms was similar among treatment groups during the 15-day postvaccination surveillance periods. No significant difference in vaccine take after 2 doses (88.0% in high dose group and 81.5% in low dose group) was seen between vaccine groups (P = 0.153). CONCLUSIONS: Two doses of either dosage level of HRV vaccine administered concurrently with routine childhood vaccines to healthy infants 5-15 weeks of age were well-tolerated and were highly immunogenic.

Administration, Oral↗
PubMed2004

Vaccination success rate and reaction profile with diluted and undiluted smallpox vaccine: a randomized controlled trial.

CONTEXT: Additional smallpox vaccine doses are needed to augment current US national stockpile. Aventis Pasteur smallpox vaccine (APSV), initially manufactured in the 1950s from the New York Board of Health vaccinia strain in a frozen preparation, appears as effective as lyophilized vaccine but the effectiveness of diluted doses of APSV is unclear. OBJECTIVE: To compare the vaccination success rate and the reaction profile of various APSV dilutions. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized controlled trial of 340 healthy vaccinia-naive adults aged 18 to 32 years from 3 academic medical centers who were vaccinated with 1 of 3 strengths of APSV dilutions (undiluted, 1:5, and 1:10) between October 9, 2002, and February 24, 2003. Volunteers were followed up every 3 to 5 days until the vaccination site healed for bandage changes, vaccine response assessment, and adverse event evaluation, followed by 1- and 2-month clinic evaluations and 6-month telephone interview. MAIN OUTCOME MEASURES: Successful vaccination, defined by presence of a vesicle or pustule at the inoculation site 6 to 11 days postvaccination, and local and systemic reactions to vaccination. RESULTS: A total of 340 volunteers were vaccinated (vaccine dose: undiluted, n = 113; 1:5 dilution, n = 114; and 1:10 dilution, n = 113). Following vaccination, 99.4% (95% confidence interval [CI], 97.9%-99.9%) of all volunteers had successful vaccinations. Success rates did not differ between the dilution groups (undiluted, 100.0%; 95% CI, 96.8%-100.0%; 1:5 dilution, 98.2%; 95% CI, 93.8%-99.8%; 1:10 dilution, 100.0% 95% CI, 96.8%-100.0%; P =.33). Overall, 99.7% of volunteers reported at least 1 local symptom at the vaccination site, and 61.8% had axillary lymphadenopathy, 15.0% developed satellite lesions, and 7.6% developed a rash away from the vaccination site. Fever developed in 21.5%. No differences were noted in local or systemic reactions between the 3 dilution groups (P>.05 for each comparison). A total of 25% of volunteers missed scheduled duties due to vaccine-related symptoms. CONCLUSIONS: Even at diluted doses, APSV is an effective smallpox vaccine, allowing for expansion of the current stockpile. However, reactogenicity was not reduced with dilution of the vaccine and, as with other smallpox vaccines, may impair daily activities.

Adult↗
PubMed2004

Treatment of herpes simplex virus infections.

Herpes simplex virus (HSV) types 1 and 2 are ubiquitous organisms that cause infections in human populations throughout the world. The clinical manifestations of HSV infections are varied, ranging from asymptomatic disease to life-threatening illness in neonates and immunocompromised hosts. This article will review the common presentations for HSV disease and the current recommendations for the treatment of these infections. A detailed summary of the antiviral drugs used to treat HSV infections is also presented.

Antiviral Agents↗
PubMed2004

Factors predicting the acceptance of herpes simplex virus type 2 antibody testing among adolescents and young adults.

BACKGROUND: The rates and determinants of acceptance of herpes simplex virus type 2 (HSV-2) testing have not been adequately studied. OBJECTIVES: The objective of this study was to identify factors associated with acceptance of HSV-2 antibody testing in individuals with no history of genital herpes. STUDY: We conducted a cross-sectional survey study followed by the offer of free HSV-2 serologic testing at an urban sexually transmitted disease (STD) clinic, 2 general adult medical clinics, an urban university campus, and an urban adolescent medicine clinic. A total of 1199 individuals aged 14 to 30 years completed the survey and were offered testing. RESULTS: A total of 68.4% accepted HSV-2 testing. Factors independently associated with acceptance were female sex, older age, having an STD history, having 1 or more sexual partners in the last 6 months, perceived vulnerability to HSV-2 infection, and perceived benefits of HSV-2 testing. Fear of needles predicted rejection of testing, as did attending a general medical clinic versus an STD clinic and nonwhite race. CONCLUSION: There is a substantial interest in HSV-2 antibody testing across a variety of settings. Those at greatest behavioral and historic risk for HSV-2 infection, women, and persons whose health beliefs are consistent with testing are more likely to accept serologic testing when it is offered.

Adolescent↗
PubMed2003

Renal, hepatic, and marrow dysfunction in a patient with chronic renal insufficiency.

Severe illness with acute renal failure, leukopenia, thrombocytopenia, and coagulopathy frequently occurs with hemolytic uremic syndrome/thrombotic thrombocytopenic purpura, hematological malignancies, sepsis, and collagen-vascular diseases. We present a 16-year-old male fast-food worker with underlying chronic renal insufficiency who manifested these abnormalities as a result of Ehrlichia chaffeensis sepsis. Doxycycline therapy and aggressive supportive care led to complete recovery.

Adolescent↗