UBC Faculty Research and Publications

MenB vaccine in preterm infants Sadarangani, Manish; Barlow, Sheula; Anthony, Mark; Pollard, Andrew J. Mar 20, 2017

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1 MenB vaccine in preterm infants Manish Sadarangani1,2,3*, Sheula Barlow2,3, Mark Anthony3, Andrew J Pollard2,3  Authors’ Affiliations 1Vaccine Evaluation Center, BC Children’s Hospital Research Institute, University of British Columbia, Vancouver BC, Canada 2Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK 3Department of Paediatrics, Oxford University Hospitals NHS Foundation Trust, Oxford, UK  Keywords: meningococcal, immunization, premature, neonate, fever  Running title: MenB vaccine in preterm infants  *Author for correspondence: Dr Manish Sadarangani Vaccine Evaluation Center, BC Children’s Hospital Research Institute, 950 West 28th Ave, Vancouver BC  V5Z 4H4, Canada.  Telephone: +1 604 875 2422 Fax: +1 604 875 2635 Email: msadarangani@cfri.ca   2 Alternate Author for correspondence: Professor Andrew Pollard Department of Paediatrics, University of Oxford, Level 2, Children’s Hospital, John Radcliffe Hospital, Oxford OX3 9DU, UK.  Telephone: +44 1865 234226 Fax: +44 1865 289695 Email: andrew.pollard@paediatrics.ox.ac.uk    3 To The Editor,  The 4CMenB vaccine was introduced into the routine immunization schedule in the UK in September 2015 to protect against group B Neisseria meningitidis meningitis and septicemia. The vaccine is reactogenic in young infants, causing fever in 51-65% when co-administered with other vaccines [1, 2]. This led to the unprecedented recommendation that all infants receive prophylactic paracetcmol (acetaminophen) with the vaccine. Preterm infants are immunized at the same chronological age and same schedule as term infants but have higher rates of post-immunization adverse events (AEs), particularly those infants born at <28 weeks gestation who are hospitalized in the neonatal unit when immunized [3]. Preterm babies were excluded from 4CMenB trials pre-licensure and no such trials have been registered (clinicaltrials.gov, 14th October 2016). Administration of a reactogenic vaccine in this population has led to heightened concern about AEs. This may impact on use of the vaccine in very preterm infants until they are discharged home, thus delaying protection of this vulnerable group against meningococcal disease.  During a study of rotavirus vaccine in hospitalized preterm infants (RotaNeo), we recruited babies before and after introduction of 4CMenB in the UK (clinicaltrials.gov, NCT02252029), providing a unique opportunity to compare preterm babies who did or did not receive 4CMenB. The primary study objective was to establish the duration of fecal rotavirus vaccine excretion post-immunization. Solicited and unsolicited AEs were collected contemporaneously up to 7 days post-immunization from parents, nursing staff and medical records. Sixty-four post-immunization data points were collected for each participant, with no missing data. Of 17 babies who completed the study, 8 received 4CMenB and 9 did not; all received other routine 4 immunizations. The overall mean gestational age at birth was 27.1 weeks (range 24.0-29.6 weeks) and mean age at immunization was 9.5 weeks, with no difference between those who did and did not receive 4CMenB (Table). Only 3 babies who were given 4CMenB received paracetamol. Of the 5 who did not, 1 had a post-immunization fever and 3 had a low temperature in the 2 days post-immunization. None of the babies who did not receive 4CMenB had temperature instability. Overall 4CMenB recipients were significantly more likely to have any temperature instability (50% vs 0%, p=0.029). Decreased feeding and reduced activity were more common in the 4CMenB group, whereas irritability and crying occurred more frequently in the babies not receiving 4CMenB (Table), which may be in part due to the use of acetaminophen in some of the 4CMenB recipients.   This study provides the first data on AEs following 4CMenB in preterm hospitalized infants, suggesting an increase in some AEs with 4CMenB, most notably temperature instability. Larger studies are needed (~70 babies per group for 90% power with 5% alpha based on these data) to inform guidance for monitoring post-immunization in these infants and use of prophylactic acetaminophen, since low temperature was more common than fever.   5 Table. Demographics and rates of post-immunization adverse events in babies who did or did not receive 4CMenB up to 2 days and 7 days post-immunization  No 4CMenB (n=9) 4CMenB (n=8) p-value1 Demographics    Birth GA (wks), mean (SD) 26.4 (0.9) 27.9 (2.2) 0.106 Age (wks), mean (SD) 9.4 (1.4) 9.5 (1.4) 0.882 Paracetamol (acetaminophen) given, n (%) 0 3 (38) na     Adverse events on day of and up to 2 days post-immunization  Any adverse event, n (%) 6 (67) 6 (75) 1.000 Fever ≥38.0oC, n (%) 0 1 (13) 0.471 Low temperature, n (%) 0 3 (38) 0.082 Any temperature instability, n (%) 0 4 (50) 0.029 Decreased feeding, n (%) 1 (11) 4 (50)2 0.131 Less active, n (%) 2 (22)3 6 (75)4 0.057 More irritable, n (%) 3 (33) 0 0.206 Cried persistently, n (%) 2 (22) 0 0.471 Vomiting, n (%) 3 (33) 2 (25) 1.000 Diarrhea, n (%) 2 (22) 1 (13) 1.000 Respiratory compromise, n (%) 15 46 0.131     Adverse events on day of and up to 7 days post-immunization  Any adverse event, n (%) 6 (67) 7 (88) 0.577 Fever ≥38.0 oC, n (%) 0 2 (25) 0.206 Low temperature, n (%) 0 3 (38) 0.082 Any temperature instability, n (%) 0 5 (63) 0.009 Decreased feeding, n (%) 1 (11) 4 (50)2 0.131 Less active, n (%) 2 (22)3 6 (75)4 0.057 More irritable, n (%) 3 (33) 1 (13) 0.576 Cried persistently, n (%) 2 (22) 0 0.471 Vomiting, n (%) 3 (33) 4 (50) 0.637 Diarrhea, n (%) 3 (33) 1 (13) 0.576 Respiratory compromise, n (%) 25,7 46 0.3348 1Comparison of 4CMenB vs non-4CMenB groups done using Fisher’s exact test; 21 classified as severe (day 1 post-immunization); 31 classified as severe (day of immunization); 43 classified as severe (all day 1 post-immunization); 5Apnoea, bradycardia and desaturation; 6Apnoea and desaturation in 1 baby and desaturation only in 3 babies; 7Event on day 7 post-immunization required re-intubation   6 Funding The RotaNeo study was funded by a grant awarded to MS by the Medical Research Fund, University of Oxford [grant number MRF/MT2013/2066]. Conflict of Interest MS has been an investigator on investigator-initiated research studies funded by Pfizer. AJP is a Jenner Investigator and James Martin Senior Fellow and has previously conducted research on behalf of Oxford University funded by vaccine manufacturers. MS and AJP have not received any personal remuneration from vaccine manufacturers. AJP is chair of the UK Department of Health’s (DH) Joint Committee on Vaccination and Immunization (JCVI); the views presented in this manuscript do not necessarily represent the views of DH or JCVI. Other authors have no conflict of interest. References 1. Gossger N, Snape MD, Yu LM, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573-82. PubMed PMID: 22318278. Epub 2012/02/10. eng. 2. Vesikari T, Esposito S, Prymula R, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381(9869):825-35. PubMed PMID: 23324563. Epub 2013/01/18. eng. 3. DeMeo SD, Raman SR, Hornik CP, Wilson CC, Clark R, Smith PB. Adverse Events After Routine Immunization of Extremely Low-Birth-Weight Infants. JAMA Pediatr. 2015;169(8):740-5. PubMed PMID: 26030302. Pubmed Central PMCID: PMC4523398.  

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