Progenies, Somatix in phase III cancer vaccine trials

Sequential design of phase II-III cancer trials.

Although traditional phase II cancer trials are usually single arm, with tumor response as endpoint, and phase III trials are randomized and incorporate interim analyses with progression-free survival or other failure time as endpoint, this paper proposes a new approach that seamlessly expands a randomized phase II study of response rate into a randomized phase III study of time to failure. Thi...

Socio-behaviour challenges to phase III HIV vaccine trials in Sub-Saharan Africa.

BACKGROUND A number of countries in sub-Saharan Africa are preparing for HIV vaccine efficacy trials. Social and behavioural factors related to HIV transmission require examination in each setting where these trials are considered. As part of this, several countries have also recently begun preparatory research investigating relevant social and behavioural issues. There is a need for a review o...

Cytokine Profile of Children Hospitalized with Virologically-Confirmed Dengue during Two Phase III Vaccine Efficacy Trials

BACKGROUND Two large-scale efficacy studies with the recombinant yellow fever-17D-dengue virus, live-attenuated, tetravalent dengue vaccine (CYD-TDV) candidate undertaken in Asia (NCT01373281) and Latin America (NCT01374516) demonstrated significant protection against dengue disease during two years' active surveillance (active phase). Long-term follow up of participants for breakthrough diseas...

Public health. A sound rationale needed for phase III HIV-1 vaccine trials.

T he need for a human immunodeficiency virus–1 (HIV-1) vaccine is unques-tioned, and we strongly support its development as the highest AIDS research priority. We have a concern about the wisdom of the U.S. government's sponsoring a recently initiated phase III trial in Thailand of a vaccine made from the live-replicating canarypox vector ALVAC (from Aventis Pasteur) with a boost of monomeric g...

Design of Phase III Clinical Trials