1687. Randomized, Placebo-Controlled Trial of DTwP Vaccine in Preterm, Very-Low-Birth-Weight (VLBW) Infants in the Neonatal Intensive Care Unit (NICU): Was Apnea a Problem?
Session: Oral Abstract Session: Vaccines in the Young and Vulnerable
Friday, October 28, 2016: 2:30 PM
Room: 388-390
Background: Respiratory decompensation, and in particular, apnea/bradycardia (A/B), has been associated with administration of DTwP (diphtheria, tetanus, whole cell pertussis) vaccine to preterm infants in the NICU. Our objective was to evaluate the occurrence of A/B after immunization (IMM) with DTwP vaccine in VLBW infants (BW ≤1500 g) in the NICU.

Methods: Prospective, randomized, double-blind, placebo-controlled, cross-over study of DTwP vaccine vs. placebo (sterile water) administered to preterm VLBW infants (stratified by BW ≤ or >1000 g) in the NICU at Parkland Hospital, Dallas, TX from 1993-1997. At the time of first IMM, infants received 0.5 ml of DTwP or sterile water intramuscularly, monitored for 3 days, followed by receipt of the other preparation on the 4thday. All infants had cardiorespiratory monitoring performed for 3 days before and continued through 3 days after the study doses. Pertinent clinical/laboratory data were collected. Specifically, the number of A/B events, respiratory interventions before and after IMM, and adverse effects were evaluated. The primary outcome was recurrence of A/B or a 50% increase in the number of A/B episodes in the 72 hours after IMM with DTwP.

Results: 154 (94%) of 163 eligible infants were enrolled and randomized; 5 infants were excluded from analysis (1, received 1 study drug; 4, missing data). The remaining 149 infants (60%, male; 50%, Hispanic; 40%, Black) had a mean (±SD) BW of 932 ±19 g and gestational age of 27.3 ±0.2 wk. 99% had a history of apnea of prematurity; 29% had BPD. They received the first study drug at a mean (±SD) age of 65.7 ±0.7 days when weighing 2110 ±43 g. Only 4 were intubated at the time of study drug administration. 29 (19%) infants had recurrence of A/B or 50% increase in A/B episodes after receipt of DTwP vaccine vs. 18 infants (12%) after sterile water injection (p=0.11; Table). 1 infant had fever (DTwP), 1 had hyporesponsive episode (placebo), and 13 had sepsis evaluations (7, DTwP; 6, placebo). 
DTwP Placebo P-value
Apnea after vaccination
Recurrence or 50% Increase 29 (19%) 18 (12%) 0.11
Recurrence 17 (11%) 13 (9%) 0.56
50% increase 12 (8%) 5 (3%) 0.13
Unchanged 95 (64%) 96 (64%) 1.00
Decreased 25 (17%)  35 (23%) 0.19

Conclusion: A/B are common in preterm VLBW infants, but DTwP vaccine was well-tolerated and compared with placebo, not associated with a transient increase or recurrence of A/B in these infants. 

Morvarid Elahi, MD1, Janet Sumner, RN, PNP, PhD2, John Gard, Pharm. D., MBA2, Linda Fisher, RN, PNP2 and Pablo J. Sanchez, MD, FIDSA, FPIDS3, (1)Nationwide Children Hospital, Columbus, OH, (2)Parkland Health & Hospital System, Dallas, TX, (3)Pediatrics, Divisions of Pediatric Infectious Diseases and Neonatology, Nationwide Children's Hospital - Ohio State University College of Medicine, Columbus, OH


M. Elahi, None

J. Sumner, None

J. Gard, None

L. Fisher, None

P. J. Sanchez, AbbVie, Inc: Scientific Advisor , Speaker honorarium

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