Preparation for phase III HIV vaccine efficacy trials: methods for the determination of HIV incidence.
OBJECTIVE
Accurate estimates of HIV incidence that reflect the effect of non-vaccine interventions (education, counselling, condom promotion, and possibly sexually transmitted disease treatment) and that may be provided in a Phase III vaccine efficacy trial, are needed so that vaccine trial population sample sizes can be accurately determined. In order to avoid delays in the implementation of efficacy trials, well characterized cohorts must also be developed and available to participate in such trials. We reviewed the potential study populations, the epidemiologic methods for the determination of HIV incidence (using open cohort, closed cohort, and seroprevalence data methods), and the need for the development of population cohorts in preparation for Phase III HIV vaccine efficacy trials.


METHODS
Phase III trials in developed and developing countries.


METHODS
Comparison of open and closed cohorts and those using seroprevalence data to estimate HIV incidence.


RESULTS
Open and closed cohorts each have disadvantages and advantages. However, the open cohort may be more suitable for determining estimates of HIV incidence that reflect non-vaccine interventions and for the development of a well characterized cohort available to participate in efficacy trials.


CONCLUSIONS
Careful preparation of research infrastructures and population cohorts will help ensure the successful conduct of scientifically and ethically sound HIV vaccine efficacy trials in the future.
Heyward
W L
WL
Vaccine Development Unit, World Health Organization, Geneva, Switzerland.
Osmanov
S
S
Saba
J
J
Esparza
J
J
Belsey
E
E
Stoneburner
R
R
Kaldor
J
J
Smith
P G
PG
D016915:AIDS Vaccines / Q000494:pharmacology*; D001699:Biometry / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods* / Q000706:statistics & numerical data; D015331:Cohort Studies; D003627:Data Interpretation, Statistical; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D015528:HIV Seroprevalence; D006801:Humans; D008297:Male; D011247:Pregnancy
D016915:AIDS Vaccines