Details:

Alternative Title:
Vaccine
Personal Author:
Monath, Thomas P.; Seligman, Stephen J.; Robertson, James S.; Guy, Bruno; Hayes, Edward B.; ... More +
Monath, Thomas P.; Seligman, Stephen J.; Robertson, James S.; Guy, Bruno; Hayes, Edward B.; Condit, Richard C.; Excler, Jean Louis; Mac, Lisa Marie; Carbery, Baevin; Chen, Robert T; Less -
Corporate Authors:
The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG);
Description:
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.
Subject:
[+]
Article
Brighton Collaboration
Drug Carriers
Genetic Vectors
Humans
Randomized Controlled Trials As Topic
Risk/Benefit Assessment
Risk Assessment
Vaccines
Vaccines, Attenuated
Vaccines, Synthetic
Vaccine Safety
Viral Vaccines
Viral Vector
Yellow Fever Vaccine
Yellow Fever Virus

Source:
Vaccine. 33(1):62-72;
Pubmed ID:
25446819
Pubmed Central ID:
PMC4656044
Document Type:
Journal Article;
Funding:
CC999999/Intramural CDC HHS/United States;
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:bb30e77b03823bd4b06aff39f45d13eaf63d7c886a4b20b682fb864f187d3a85
File Type:

Supporting Files

• nihms735720.nxml

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