Trial reportHuman vaccines & immunotherapeutics2017
Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women.
Trial report in Human vaccines & immunotherapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- The association between vaccine hesitancy and pertussis: a systematic review and meta-analysis.Italian journal of pediatrics · 2023Pooled it
- Safety and effectiveness of acellular pertussis vaccination during pregnancy: a systematic review.BMC infectious diseases · 2020Pooled it
- Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2018Guideline
- Efficacy, Immunogenicity, and Safety of Pertussis Vaccine During Pregnancy: A Meta-Analysis.Vaccines · 2025Review
- Defining and reporting adverse events of special interest in comparative maternal vaccine studies: a systematic review.Vaccine: X · 2024Review
- Safety and Clinical Benefits of AdacelInfectious diseases and therapy · 2023Review
- Impact of maternal whole-cell or acellular pertussis primary immunization on neonatal immune response.Frontiers in immunology · 2023Article
- Evaluation of Whole-Cell and Acellular Pertussis Vaccines in the Context of Long-Term Herd Immunity.Vaccines · 2022Review
- Vaccination in Pregnancy against Pertussis: A Consensus Statement on Behalf of the Global Pertussis Initiative.Vaccines · 2022Review
- Protecting the Offspring, the Gift of Maternal Immunization: Current Status and Future Perspectives.Vaccines · 2022Review
- Safety and Immunogenicity of Pertussis Vaccine Immunization during Pregnancy: A Meta-Analysis of Randomized Clinical Trials.Journal of tropical medicine · 2022Review
- Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement.Frontiers in immunology · 2020Review
- Vertically Transferred Immunity in Neonates: Mothers, Mechanisms and Mediators.Frontiers in immunology · 2020Review
- Safety of Maternal Immunization Against Pertussis: A Systematic Review.Infectious diseases and therapy · 2019Review
- Immunological and Clinical Benefits of Maternal Immunization Against Pertussis: A Systematic Review.Infectious diseases and therapy · 2019Review
- The Effect of Maternal Immunisation During Pregnancy on Infant Vaccine Responses.EClinicalMedicine · 2019Article
- Observational
- Pertussis epidemiology in Argentina: TRENDS after the introduction of maternal immunisation.Epidemiology and infection · 2018Article
- Antibodies toPeerJ · 2017Article
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 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immunization with the tetanus, diphtheria, and pertussis (Tdap) vaccine raises controversies on immunogenicity and possible antibody interference. We performed an experimental, double-blind, parallel group controlled clinical trial to evaluate the safety and immunogenicity of the Tdap vaccine in 204 pregnant women and their children and to determine its interference in antibody production. Pregnant women 18 to 38 y of age with 12 to 24 weeks gestation, a low obstetric risk, and without serious disease were randomly selected. The experimental group received 0.5 mL IM of Tdap and the control group normal saline. Six blood samples were drawn before and after solution application, and from the umbilical cord of the infants and at 2, 4, and 6 months of age. Pertactin and Pertussis toxin antibodies and possible interference of maternal antibodies with the vaccine were determined. In the experimental group, antibodies against Bordetella pertussis pertactin (anti-PRN) (112 E/mL 95% CI 89.9-139.9) and antibodies against pertussis toxin (anti-PT) (24.0 E/mL, 95% CI 18.3-31.4) were elevated in the mother before vaccination. These were higher in the umbilical cord and descended in the infant at 2 months (71.4 (95% CI 56.8-89.7 and 10.9; 95% CI 8.7-13.7, respectively). Anti-PT showed a delay in production. Tdap safety was confirmed with only mild local pain at 24 and 48 hours. Anti-PRN and anti-PT antibodies in the infant descend at 2 months of age. There is a delay in anti-PT in children of immunized mothers. Further studies are needed to elucidate its clinical significance.
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