Immunogenicity of PCV-7 Vaccine in VLBW Infants



Status:Completed
Conditions:Pneumonia, Infectious Disease, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:July 2004
End Date:March 2009

Use our guide to learn which trials are right for you!

Observational Study of the Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Very-low-birth-weight Infants

Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents
the invasive disease from Streptococcus pneumoniae in full-term infants, but was not
thoroughly studied in premature infants. This study evaluated the effectiveness and safety of
the vaccine given in routine practice to very low birth weight infants, looking at blood
antibody levels 4-6 weeks after the final vaccine dose, and adverse events, survival,
infections, and neurodevelopmental outcomes at 18-22 months corrected age.

Streptococcus pneumoniae causes an estimated 10-25% of all pneumonias in the United States,
and is responsible for an estimated 40,000 deaths per year. Invasive pneumococcal disease has
a peak incidence of 235/100,000 among children aged 6-11 months. Pneumococcal meningitis
carries a higher risk of death (15%) or neurodevelopmental impairment (12-28%) than Hib or
Neisseria meningitides.

Premature infants are at a higher risk for invasive disease with Streptococcus pneumoniae.
The heptavalent pneumococcal-CRM197 conjugate vaccine (PCV-7) effectively prevents invasive
pneumococcal disease in full-term infants, but was been incompletely studied in premature
infants. The American Academy of Pediatrics (AAP) recommends that "prematurely born infants,
including infants of low birth weight, should be immunized at the usual chronological age in
most cases", but cautions that "some studies suggest a reduced immune response in very
low-birth-weight infants (<1500 g)."

This observational study assessed the effectiveness of the PCV-7 vaccine to generate a
sufficient immune response in a safe manner when given to very low birth weight (VLBW)
infants in routine pediatric practice. We hypothesized that among VLBW infants, the frequency
of estimated minimum protective antibody titers to PCV-7 (>=0.15 μg/mL) would decrease with
decreasing birth weight.

Infants 501-1500g birth weight and <32 0/7 weeks gestational age were enrolled from nine
NICHD Neonatal Research Network centers from 2004 to 2006. Enrollment was stratified by
weight group to yield approximately 20 infants per 100g increments from 501-1500g birth
weight whose primary PCV-7 series was initiated before 3 months and completed by 8 months
after birth. The infants' primary providers gave PCV-7 vaccination at 2, 4, and 6 months
after birth. Infants had a single 2-ml blood sample drawn 4-6 weeks following the third dose
of PCV-7. Antibodies for each of the seven vaccine serotypes included in PCV-7 were measured
by enzyme-linked immunosorbent assay. Children were followed until 18-22 months corrected age
to assess survival, infection, and neurodevelopmental outcomes.

Inclusion criteria

- Gestational age <32 0/7 weeks

- Included in Neonatal Research Network Generic Database

- Family has a telephone at home

- Anticipated availability for blood draw 4-6 weeks following 3rd vaccine dose

- Consent obtained before first dose of PCV-7 is given

Exclusion criteria

- Known immunodeficiency

- HIV exposure

- Parental non-consent

- Primary care pediatrician not willing to participate

- Enrollment in a conflicting trial

- Infant has not received first dose of PCV-7 vaccine by 3 months of age
We found this trial at
10
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
?
mi
from
Durham, NC
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Charlotte, North Carolina 27157
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials