Table 2

Needs assessment and recommendations.

Working group Needs and recommendations
GBS epidemiology and vaccine need in developed countries • Standardize surveillance data throughout Europe
• Raise awareness of GBS disease
GBS epidemiology and vaccine need in developing countries • Standardize surveillance worldwide
• Arrange PCR or culture-free testing
• Set up studies to assess true disease burden
Moving forward with a maternal immunization platform • Collect epidemiology data to drive decision-making
• Evaluate the impact of maternal immunization on natural infection and response to vaccines in infants
• Assess duration of protection provided to infants by maternal immunization
• Study correlates of protection to estimate extent of achievable protection in infants
• Educate mothers, providers, and public health officials about the need for vaccination and vaccine safety
Optimal phase 3 trial design for a GBS vaccine in pregnant women • A trial should simulate real-world use of vaccine to assess potential impact
• Define optimal time in pregnancy to vaccinate
• Assess impact not only on GBS disease but other pregnancy outcomes such as prematurity
• Identify sites with large disease burden but adequate laboratory facilities