A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations

Wysocki, Jacek; Brzostek, Jerzy; Majda-Stanisławska, Ewa; Szymański, Henryk; Szenborn, Leszek; Czajka, Hanna; Hasiec, Barbara; Dziduch, Jerzy; Jackowska, Teresa; Witor, Anita; Kopińska, Elżbieta; Konior, Ryszard; Giardina, Peter C.; Sundaraiyer, Vani; Patterson, Scott D.; Gruber, William C.; Scott, Daniel A.; Gurtman, Alejandra

doi:10.1016/j.vaccine.2017.02.035

Cited by 35 publications

(29 citation statements)

References 38 publications

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“…After a booster dose, lower GMTs persisted in the prophylactic paracetamol group for all Pn serotypes, diphtheria, and tetanus (563). The one study that investigated the effect of ibuprofen administration around the time of vaccination shows that GMTs to FHA and tetanus are diminished after primary administration but not after a booster dose, while responses to conjugated Pn vaccine are not affected (564). Further, a recent large study in elderly individuals showed that the intake of statins diminishes GMTs to TIV (565).…”

Section: Administration Factorsmentioning

confidence: 99%

Factors That Influence the Immune Response to Vaccination

2019

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SUMMARYThere is substantial variation between individuals in the immune response to vaccination. In this review, we provide an overview of the plethora of studies that have investigated factors that influence humoral and cellular vaccine responses in humans. These include intrinsic host factors (such as age, sex, genetics, and comorbidities), perinatal factors (such as gestational age, birth weight, feeding method, and maternal factors), and extrinsic factors (such as preexisting immunity, microbiota, infections, and antibiotics). Further, environmental factors (such as geographic location, season, family size, and toxins), behavioral factors (such as smoking, alcohol consumption, exercise, and sleep), and nutritional factors (such as body mass index, micronutrients, and enteropathy) also influence how individuals respond to vaccines. Moreover, vaccine factors (such as vaccine type, product, adjuvant, and dose) and administration factors (schedule, site, route, time of vaccination, and coadministered vaccines and other drugs) are also important. An understanding of all these factors and their impacts in the design of vaccine studies and decisions on vaccination schedules offers ways to improve vaccine immunogenicity and efficacy.

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Section: Administration Factorsmentioning

confidence: 99%

Factors That Influence the Immune Response to Vaccination

2019

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“…Most of the preventable AEFI reports were due to the potential interaction between the components of the vaccines or between the vaccines and concomitant medications administered to the patients. Previous studies have documented poor immunologic response to conjugated Pneumococcus vaccine following acetaminophen administration (Prymula et al, 2009; Falup-Pecurariu et al, 2017; Wysocki et al, 2017). We also reported one case of interaction between varicella, live-attenuated vaccine, and the glucocorticoid betamethasone, which may result in an inadequate immunological response to the live vaccine (Infectious Diseases and Immunization Committee, Canadian Paediatric Society, 2000; Liu et al, 2013).…”

Section: Discussionmentioning

confidence: 99%

Vaccines Safety in Children and in General Population: A Pharmacovigilance Study on Adverse Events Following Anti-Infective Vaccination in Italy

et al. 2019

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Background: The concern for adverse events following immunization (AEFI) and anti-vaccination movements that lacked scientific evidence-based supports may reduce vaccine uptake in the general population. Thus, the aims of the present study were to characterize AEFI in general population (all age groups), in terms of frequency, preventability, and seriousness and to define predictors of their seriousness in children. Methods: A retrospective study was performed on suspected AEFI reports for children and adults who received any form of vaccinations, collected in Tuscany, Italy, between 1 January and 31 December 2017. Patients’ characteristics, suspected vaccines, and AEFI description were collected. Causality and preventability were assessed using WHO and Schumock and Thornton algorithms, respectively. Logistic regression was used to estimate the reporting odds ratios of potential predictors of AEFI seriousness in children. Results: A total of 223 suspected AEFI reports were collected, and the majority of them were defined as non-serious (76.7%). Reports were mostly related to one vaccine, and to a median of two to five strains/toxoids. The total number of simultaneously administered strains/toxoids and the presence of allergens did not correlate with AEFI seriousness. Considering vaccines with a high number of administered doses (≥60,000 doses), the rates estimated for serious AEFI reports were always very low, ranging between 0.01 and 0.2/1,000 doses. Twenty-four vaccines (8,993 doses) were not related to any AEFI. Conclusion: Results of present study showed that AEFI were very rare; the vast majority of them was non-serious and, despite the claims of anti-vaccination movements, the simultaneous administration of vaccines was safe and did not influence the risk of reporting a serious AEFI, particularly in children.

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“…These effects were especially apparent when antipyretic prophylaxis was administered at the time of primary vaccination, while no differences were observed after the booster dose. 11 …”

Section: Discussionmentioning

confidence: 99%

“…Prophylactic administration of paracetamol also seemed to interfere with immune responses to the PCV13 in infants, while ibuprofen appeared to reduce responses to pertussis filamentous haemagglutinin (FHA) and tetanus antigens without impacting pneumococcal responses. 11 …”

Section: Introductionmentioning

confidence: 99%

Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeableHaemophilus influenzaeprotein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial

Falup‐Pecurariu

Man

Neamtu

et al. 2016

Human Vaccines & Immunotherapeutics

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Prophylactic paracetamol administration impacts vaccine immune response; this study (www.clinicaltrials.gov: NCT01235949) is the first to assess PHiD-CV immunogenicity following prophylactic ibuprofen administration. In this phase IV, multicenter, open-label, randomized, controlled, non-inferiority study in Romania (November 2010–December 2012), healthy infants were randomized 3:3:3:1:1:1 to prophylactically receive immediate, delayed or no ibuprofen (IIBU, DIBU, NIBU) or paracetamol (IPARA, DPARA, NPARA) after each of 3 primary doses (PHiD-CV at age 3/4/5 months co-administered with DTPa-HBV-IPV/Hib at 3/5 and DTPa-IPV/Hib at 4 months) or booster dose (PHiD-CV and DTPa-HBV-IPV/Hib; 12–15 months). Non-inferiority of immune response one month post-primary vaccination in terms of percentage of infants with anti-pneumococcal antibody concentrations ≥0.2 µg/mL (primary objective) was demonstrated if the upper limit (UL) of the 98.25% confidence interval of difference between groups (NIBU vs IIBU, NIBU vs DIBU) was <10% for ≥7/10 serotypes. Immunogenicity and reactogenicity/safety were evaluated, including confirmatory analysis of difference in fever incidences post-primary vaccination in IBU or DIBU group compared to NIBU. Of 850 infants randomized, 812 were included in the total vaccinated cohort. Non-inferiority was demonstrated for both comparisons (UL was <10% for 9/10 vaccine serotypes; exceptions: 6B [NIBU], 23F [IIBU]). However, fever incidence post-primary vaccination in the IIBU and DIBU groups did not indicate a statistically significant reduction. Prophylactic administration (immediate or delayed) of paracetamol decreased fever incidence but seemed to reduce immune response to PHiD-CV, except when given only at booster. Twenty-seven serious adverse events were reported for 15 children; all resolved and were not vaccination-related.

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A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations

Cited by 35 publications

References 38 publications

Factors That Influence the Immune Response to Vaccination

Factors That Influence the Immune Response to Vaccination

Vaccines Safety in Children and in General Population: A Pharmacovigilance Study on Adverse Events Following Anti-Infective Vaccination in Italy

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