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editorial
. 2007 Mar 26;6:36. doi: 10.1186/1475-2875-6-36

Table 1.

Comparison of endpoints of vaccine trials. The mode of action of the vaccine will determine the type of trial and endpoint that is used to evaluate their efficacy.

Target of vaccine* Trial Endpoint Vaccine efficacy Type of follow up References
Pre-erythrocytic Sporozoite challenge (Phase IIa) Infection 1NVNUV MathType@MTEF@5@5@+=feaafiart1ev1aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacH8akY=wiFfYdH8Gipec8Eeeu0xXdbba9frFj0=OqFfea0dXdd9vqai=hGuQ8kuc9pgc9s8qqaq=dirpe0xb9q8qiLsFr0=vr0=vr0dc8meaabaqaciaacaGaaeqabaqabeGadaaakeaacqaIXaqmcqGHsisldaWcaaqaaiabd6eaonaaBaaaleaacqWGwbGvaeqaaaGcbaGaemOta40aaSbaaSqaaiabdwfavjabdAfawbqabaaaaaaa@34E2@ Daily ACD [30, 31]
Delayed patency (if vaccinees become infected) -- Daily ACD [32–34]
Number of primary merozoites** 1PVPUV MathType@MTEF@5@5@+=feaafiart1ev1aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacH8akY=wiFfYdH8Gipec8Eeeu0xXdbba9frFj0=OqFfea0dXdd9vqai=hGuQ8kuc9pgc9s8qqaq=dirpe0xb9q8qiLsFr0=vr0=vr0dc8meaabaqaciaacaGaaeqabaqabeGadaaakeaacqaIXaqmcqGHsisldaWcaaqaaiqbdcfaqzaataWaaSbaaSqaaiabdAfawbqabaaakeaacuWGqbaugaWeamaaBaaaleaacqWGvbqvcqWGwbGvaeqaaaaaaaa@351E@ Daily ACD [5]
Field trial in endemic setting (Phase IIb/III) Time to first infection or first episode 1-HR ACD (for time to infection) ACD or PCD (for first episodes) [35, 36]
Incidence of disease episodes 1IVIUV MathType@MTEF@5@5@+=feaafiart1ev1aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacH8akY=wiFfYdH8Gipec8Eeeu0xXdbba9frFj0=OqFfea0dXdd9vqai=hGuQ8kuc9pgc9s8qqaq=dirpe0xb9q8qiLsFr0=vr0=vr0dc8meaabaqaciaacaGaaeqabaqabeGadaaakeaacqaIXaqmcqGHsisldaWcaaqaaiabdMeajnaaBaaaleaacqWGwbGvaeqaaaGcbaGaemysaK0aaSbaaSqaaiabdwfavjabdAfawbqabaaaaaaa@34CE@ ACD or PCD For multiple episodes [36]
Blood stage Field trial in endemic setting Incidence of disease episodes (first episode or multiple episodes) (Phase IIb/III) 1IVIUV MathType@MTEF@5@5@+=feaafiart1ev1aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacH8akY=wiFfYdH8Gipec8Eeeu0xXdbba9frFj0=OqFfea0dXdd9vqai=hGuQ8kuc9pgc9s8qqaq=dirpe0xb9q8qiLsFr0=vr0=vr0dc8meaabaqaciaacaGaaeqabaqabeGadaaakeaacqaIXaqmcqGHsisldaWcaaqaaiabdMeajnaaBaaaleaacqWGwbGvaeqaaaGcbaGaemysaK0aaSbaaSqaaiabdwfavjabdAfawbqabaaaaaaa@34CE@ ACD or PCD [15, 16, 37]
Density of infection (Phase IIb) 1DVDUV MathType@MTEF@5@5@+=feaafiart1ev1aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacH8akY=wiFfYdH8Gipec8Eeeu0xXdbba9frFj0=OqFfea0dXdd9vqai=hGuQ8kuc9pgc9s8qqaq=dirpe0xb9q8qiLsFr0=vr0=vr0dc8meaabaqaciaacaGaaeqabaqabeGadaaakeaacqaIXaqmcqGHsisldaWcaaqaaiqbdseaezaataWaaSbaaSqaaiabdAfawbqabaaakeaacuWGebargaWeamaaBaaaleaacqWGvbqvcqWGwbGvaeqaaaaaaaa@34EE@ ACD [9]

N = number of volunteers infected, P = mean number of primary merozoites, HR = Hazards ratio, I=incidence, D = mean density, V = vaccinated, UV = unvaccinated, ACD = active case detection, PCD = passive case detection

* Transmission blocking (mosquito stage) vaccines are not considered in this analysis.

** This endpoint requires PCR and is not currently used as a primary endpoint