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Table 2 Results of simulated vaccine trials

From: Measures of clinical malaria in field trials of interventions against Plasmodium falciparum

 

Vaccine effect

 

A: Reduction in force of infection by 50%

B: Reduction in parasite densities by 50%

C: Multiplication of pyrogenic threshold by 2

Figure 1a: Distribution of parasite densities in the community (from which simulated datasets are sampled)

Frequency is halved at each density above zero. Frequency of zero parasite density increases to compensate.

Frequency of low parasite densities increases; frequency of high parasite densities decreases. Frequency of zero parasite density unchanged.

Same as placebo

Figure 1b: Distribution of parasite densities in all disease cases 1b) (from which simulated datasets are sampled)

Frequency relative to that in placebo decreases with increasing parasite density.

Frequency relative to that in placebo decreases with increasing parasite density

Frequency relative to that in placebo decreases with increasing parasite density

Figure 1c: Relative risk of given parasite density in disease cases relative to controls

At any given density, reduced relative to placebo

Same as placebo

At any given density, reduced relative to placebo

Figure 1d: Attributable fraction of cases by parasite density (Figure 1d)

At any given density, reduced relative to placebo

Same as placebo

At any given density, reduced relative to placebo

Figure 1e: Distribution of parasite densities in clinical malaria cases

Frequency of high parasite densities lower than in placebo

Frequency of high parasite densities lower than in placebo

Frequency of high parasite densities lower than in placebo

Figure 1f: Sensitivity of case definition, by parasite density

Same as placebo

At any given density, reduced relative to placebo

At any given density, reduced relative to placebo

Figure 1g: Specificity of case definition by parasite density

Same as placebo

At any given density, increased relative to placebo

Same as placebo

Figure 1h: Efficacy estimate by parasite density cut-off (x)

Estimated efficacy increases with cut-off approximates the true efficacy at high cut-off values

Estimated efficacy increase with cut-off and exceeds the true efficacy at high cut-off values

Estimated efficacy increase with cut-off and approximates the true efficacy at high cut-off values

Figure 1i: Power of study, by parasite density cut-off

Reaches a maximum of about 67% at a cut-off of about 10,000/μl

Reaches a maximum of about 87% at a cut-off of about 40,000/μl

Increases to 100% at a parasite density of about 60,000/μl

Estimated efficacy using latent class model

46.1% (18.7%)

55.6% (23.1%)

55.2% (16.5%)

Power using latent class model (1-β)

59.2%

82.4%

71.2%