Abstract
Preventing malaria during pregnancy is of critical importance, yet there are no approved malaria vaccines for pregnant women due to lack of efficacy results within this population. Conducting a randomized trial in pregnant women throughout the entire duration of pregnancy is impractical. Instead, a randomized trial was conducted among women of childbearing potential (WOCBP), and some participants became pregnant during the 2-year study. We explore a statistical method for estimating vaccine effect within the target subpopulation-women who can naturally become pregnant, namely, women who can become pregnant under a placebo condition-within the causal inference framework. Two vaccine effect estimators are employed to effectively utilize baseline characteristics and account for the fact that certain baseline characteristics were only available from pregnant participants. The first estimator considers all participants but can only utilize baseline variables collected from the entire participant pool. In contrast, the second estimator, which includes only pregnant participants, utilizes all available baseline information. Both estimators are evaluated numerically through simulation studies and applied to the WOCBP trial to assess vaccine effect against pregnancy malaria.