Last data update: May 13, 2024. (Total: 46773 publications since 2009)
Records 1-4 (of 4 Records) |
Query Trace: Carbery B[original query] |
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Live virus vaccines based on a vesicular stomatitis virus (VSV) backbone: Standardized template with key considerations for a risk/benefit assessment.
Clarke DK , Hendry RM , Singh V , Rose JK , Seligman SJ , Klug B , Kochhar S , Mac LM , Carbery B , Chen RT . Vaccine 2016 34 (51) 6597-6609 The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety of live, recombinant viral vaccines incorporating genes from heterologous viral and other microbial pathogens in their genome (so-called "chimeric virus vaccines"). Many such viral vector vaccines are now at various stages of clinical evaluation. Here, we introduce an attenuated form of recombinant vesicular stomatitis virus (rVSV) as a potential chimeric virus vaccine for HIV-1, with implications for use as a vaccine vector for other pathogens. The rVSV/HIV-1 vaccine vector was attenuated by combining two major genome modifications. These modifications acted synergistically to greatly enhance vector attenuation and the resulting rVSV vector demonstrated safety in sensitive mouse and non-human primate neurovirulence models. This vector expressing HIV-1 gag protein has completed evaluation in two Phase I clinical trials. In one trial the rVSV/HIV-1 vector was administered in a homologous two-dose regimen, and in a second trial with pDNA in a heterologous prime boost regimen. No serious adverse events were reported nor was vector detected in blood, urine or saliva post vaccination in either trial. Gag specific immune responses were induced in both trials with highest frequency T cell responses detected in the prime boost regimen. The rVSV/HIV-1 vector also demonstrated safety in an ongoing Phase I trial in HIV-1 positive participants. Additionally, clinical trial material has been produced with the rVSV vector expressing HIV-1 env, and Phase I clinical evaluation will initiate in the beginning of 2016. In this paper, we use a standardized template describing key characteristics of the novel rVSV vaccine vectors, in comparison to wild type VSV. The template facilitates scientific discourse among key stakeholders by increasing transparency and comparability of information. The Brighton Collaboration V3SWG template may also be useful as a guide to the evaluation of other recombinant viral vector vaccines. |
Live virus vaccines based on a yellow fever vaccine backbone: standardized template with key considerations for a risk/benefit assessment
Monath TP , Seligman SJ , Robertson JS , Guy B , Hayes EB , Condit RC , Excler JL , Mac LM , Carbery B , Chen RT . Vaccine 2015 33 (1) 62-72 The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety of live, recombinant viral vaccines incorporating genes from heterologous viruses inserted into the backbone of another virus (so-called "chimeric virus vaccines"). Many viral vector vaccines are in advanced clinical trials. The first such vaccine to be approved for marketing (to date in Australia, Thailand, Malaysia, and the Philippines) is a vaccine against the flavivirus, Japanese encephalitis (JE), which employs a licensed vaccine (yellow fever 17D) as a vector. In this vaccine, two envelope proteins (prM-E) of YF 17D virus were exchanged for the corresponding genes of JE virus, with additional attenuating mutations incorporated into the JE gene inserts. Similar vaccines have been constructed by inserting prM-E genes of dengue and West Nile into YF 17D virus and are in late stage clinical studies. The dengue vaccine is, however, more complex in that it requires a mixture of four live vectors each expressing one of the four dengue serotypes. This vaccine has been evaluated in multiple clinical trials. No significant safety concerns have been found. The Phase 3 trials met their endpoints in terms of overall reduction of confirmed dengue fever, and, most importantly a significant reduction in severe dengue and hospitalization due to dengue. However, based on results that have been published so far, efficacy in preventing serotype 2 infection is less than that for the other three serotypes. In the development of these chimeric vaccines, an important series of comparative studies of safety and efficacy were made using the parental YF 17D vaccine virus as a benchmark. In this paper, we use a standardized template describing the key characteristics of the novel flavivirus vaccine vectors, in comparison to the parental YF 17D vaccine. The template facilitates scientific discourse among key stakeholders by increasing the transparency and comparability of information. The Brighton Collaboration V3SWG template may also be useful as a guide to the evaluation of other recombinant viral vector vaccines. |
The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG).
Chen RT , Carbery B , Mac L , Berns KI , Chapman L , Condit RC , Excler JL , Gurwith M , Hendry M , Khan AS , Khuri-Bulos N , Klug B , Robertson JS , Seligman SJ , Sheets R , Williamson AL . Vaccine 2014 33 (1) 73-5 Recombinant viral vectors provide an effective means for heterologous antigen expression in vivo and thus represent promising platforms for developing novel vaccines against human pathogens from Ebola to tuberculosis. An increasing number of candidate viral vector vaccines are entering human clinical trials. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to improve our ability to anticipate potential safety issues and meaningfully assess or interpret safety data, thereby facilitating greater public acceptance when licensed. |
Need for physician education on the benefits and risks of male circumcision in the United States
Carbery B , Zhu J , Gust DA , Chen RT , Kretsinger K , Kilmarx PH . AIDS Educ Prev 2012 24 (4) 377-87 Physicians may be called upon to counsel male patients or parents of newborn males regarding their decision to circumcise their newborn sons. The purpose of the present study was to describe physicians who do not understand the benefits and risks associated with male circumcision well enough to counsel parents of newborn male infants and adult men. A self-administered, cross-sectional electronic survey of physicians was conducted in 2008. We analyzed responses from 1,500 physicians (510 family practitioners, 490 internists, 250 pediatricians, and 250 obstetricians/gynecologists). Nearly 22% (n = 327/1500) reported they did not understand the risks and benefits of newborn male circumcision well enough to counsel parents and 40.3% (n = 504/1250) reported not understanding the risks and benefits well enough to counsel adult men. A substantial minority of physicians may need additional training and/or information about current male circumcision research to feel comfortable counseling parents of newborn male infants or adult men. |
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