Trial reportPloS one2014
Effects of prophylactic and therapeutic paracetamol treatment during vaccination on hepatitis B antibody levels in adults: two open-label, randomized controlled trials.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02807623 ("Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
"Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation: the NEED LESS PAIN Study"
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Paracetamol (acetaminophen) use in infants and children was never shown to be safe for neurodevelopment: a systematic review with citation tracking.European journal of pediatrics · 2022Pooled it
- Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis.The Clinical journal of pain · 2015Pooled it
- Antimicrobial potentials and challenges of paracetamol: A comprehensive reassessment based on database reports.Pharmaceutical science advances · 2025Review
- The Effectiveness of Paracetamol to Reduce the Post-Vaccination SARS-CoV-2 Adverse Effects in an Italian Vaccination Center.Vaccines · 2023Article
- No significant influence of pre-vaccination antipyretic use on specific antibody response to a BNT162b2 vaccine booster against COVID-19.Vaccine: X · 2022Article
- The association between adverse reactions and immune response against SARS-CoV-2 spike protein after vaccination with BNT162b2 among healthcare workers in a single healthcare system: a prospective observational cohort study.Human vaccines & immunotherapeutics · 2022Observational
- Article
- Acetaminophen: A hazard to immunotherapy.Annals of medicine and surgery (2012) · 2022Article
- COVID-19 vaccines in patients with cancer: immunogenicity, efficacy and safety.Nature reviews. Clinical oncology · 2022Review
- Frequency and Nuisance Level of Adverse Events in Individuals Receiving Homologous and Heterologous COVID-19 Booster Vaccine.Vaccines · 2022Article
- Revision of ICH S8 Needed?Frontiers in toxicology · 2022Article
- [Vaccinations].Der Internist · 2021Article
- Should Antipyretics Be Used to Relieve Acute Adverse Events Related to COVID-19 Vaccines?Chest · 2021Article
- Effect of prophylactic administration of antipyretics on the immune response to pneumococcal conjugate vaccines in children: a systematic review.Pneumonia (Nathan Qld.) · 2021Review
- Let fever do its job: The meaning of fever in the pandemic era.Evolution, medicine, and public health · 2021Review
- The 2020 Pandemic: Current SARS-CoV-2 Vaccine Development.Frontiers in immunology · 2020Review
- The how's and what's of vaccine reactogenicity.NPJ vaccines · 2019Review
- No pain no gain? Adjuvant effects of alum and monophosphoryl lipid A in pertussis and HPV vaccines.Current opinion in immunology · 2017Review
- The role of oxidative stress, inflammation and acetaminophen exposure from birth to early childhood in the induction of autism.The Journal of international medical research · 2017Review
- Effect of antipyretic analgesics on immune responses to vaccination.Human vaccines & immunotherapeutics · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledWorldwide, paracetamol is administered as a remedy for complaints that occur after vaccination. Recently published results indicate that paracetamol inhibits the vaccination response in infants when given prior to vaccination. The goal of this study was to establish whether paracetamol exerts similar effects in young adults. In addition, the effect of timing of paracetamol intake was investigated. In two randomized, controlled, open-label studies 496 healthy young adults were randomly assigned to three groups. The study groups received paracetamol for 24 hours starting at the time of (prophylactic use) - or 6 hours after (therapeutic use) the primary (0 month) and first booster (1 month) hepatitis B vaccination. The control group received no paracetamol. None of the participants used paracetamol around the second booster (6 months) vaccination. Anti-HBs levels were measured prior to and one month after the second booster vaccination on ADVIA Centaur XP. One month after the second booster vaccination, the anti-HBs level in the prophylactic paracetamol group was significantly lower (p = 0.048) than the level in the control group (4257 mIU/mL vs. 5768 mIU/mL). The anti-HBs level in the therapeutic paracetamol group (4958 mIU/mL) was not different (p = 0.34) from the level in the control group. Only prophylactic paracetamol treatment, and not therapeutic treatment, during vaccination has a negative influence on the antibody concentration after hepatitis B vaccination in adults. These findings prompt to consider therapeutic instead of prophylactic treatment to ensure maximal vaccination efficacy and retain the possibility to treat pain and fever after vaccination.
trial registrationControlled-Trials.com ISRCTN03576945.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.