Mother's Gift Project

Johns Hopkins Bloomberg School of Public Health680 enrolled

Overview

This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.

This is a randomized vaccine evaluation in 4 groups of mothers and their infants, to assess the effect of maternal immunization on the infants' response to pneumococcal vaccine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

680

Conditions

Pneumococcal Infections

Interventions

pneumococcal polysaccharide and protein conjugate vaccinesBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Mothers from 18 to 14 years of age in the third trimester of pregnancy, * with normal medical and obstetric history, * who plan to deliver their infant in Dhaka city and remain there for 12m Exclusion Criteria: * Maternal history of systemic disease, * Maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies. * Maternal hypersensitivity to any vaccination, or * Maternal receipt of pneumococcal vaccine in the last 3 years.

Locations (1)

ICDDRB

Dhaka, Bangladesh

Outcomes

Primary Outcomes

Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age

local and systemic reactions within 2 weeks of vaccination

Secondary Outcomes

Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.

Data from ClinicalTrials.gov

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