Clinical trial NCT00142389: Mother's Gift Project
Official title: Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pneumococcal Infections
Keywords: gestational immunization,
infant antibody,
cord antibody
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: Bill and Melinda Gates Foundation
name: United States Agency for International Development (USAID)
name: Wyeth is now a wholly owned subsidiary of Pfizer
name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2005-09-02
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age
measure: local and systemic reactions within 2 weeks of vaccination
Secondary outcomes:
measure: Level and duration of serum IgG antibody to pneumococcus up to 1 year of age.
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDRB
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: M C Steinhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlaudecker EP, Steinhoff MC, Omer SB, McNeal MM, Roy E, Arifeen SE, Dodd CN, Raqib R, Breiman RF, Zaman K. IgA and neutralizing antibodies to influenza a virus in human milk: a randomized trial of antenatal influenza immunization. PLoS One. 2013 Aug 14;8(8):e70867. doi: 10.1371/journal.pone.0070867. eCollection 2013.
citation: Omer SB, Zaman K, Roy E, Arifeen SE, Raqib R, Noory L, Seib K, Breiman RF, Steinhoff MC. Combined effects of antenatal receipt of influenza vaccine by mothers and pneumococcal conjugate vaccine receipt by infants: results from a randomized, blinded, controlled trial. J Infect Dis. 2013 Apr;207(7):1144-7. doi: 10.1093/infdis/jit003. Epub 2013 Jan 8.
citation: Steinhoff MC, Omer SB, Roy E, El Arifeen S, Raqib R, Dodd C, Breiman RF, Zaman K. Neonatal outcomes after influenza immunization during pregnancy: a randomized controlled trial. CMAJ. 2012 Apr 3;184(6):645-53. doi: 10.1503/cmaj.110754. Epub 2012 Feb 21.
citation: Zaman K, Roy E, Arifeen SE, Rahman M, Raqib R, Wilson E, Omer SB, Shahid NS, Breiman RF, Steinhoff MC. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008 Oct 9;359(15):1555-64. doi: 10.1056/NEJMoa0708630. Epub 2008 Sep 17.