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).
|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.
J. Gard, None
L. Fisher, None
P. J. Sanchez, AbbVie, Inc: Scientific Advisor , Speaker honorarium