Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2017

Open Access 01-12-2017 | Research article

Efficacy and safety of pertussis vaccination for pregnant women – a systematic review of randomised controlled trials and observational studies

Authors: Marie Furuta, Jacqueline Sin, Edmond S. W. Ng, Kay Wang

Published in: BMC Pregnancy and Childbirth | Issue 1/2017

Login to get access

Abstract

Background

Worldwide, pertussis remains a major health problem among children. During the recent outbreaks of pertussis, maternal antenatal immunisation was introduced in several industrial countries. This systematic review aimed to synthesize evidence for the efficacy and safety of the pertussis vaccination that was given to pregnant women to protect infants from pertussis infection.

Methods

We searched literature in the Cochrane Central Register of Controlled Trials, Medline, Embase, and OpenGrey between inception of the various databases and 16 May 2016. The search terms included ‘pertussis’, ‘whooping cough’, ‘pertussis vaccine,’ ‘tetanus, diphtheria and pertussis vaccines’ and ‘pregnancy’ and ‘perinatal’.

Results

We included 15 articles in this review, which represented 12 study populations, involving a total of 203,835 mother-infant pairs from the US, the UK, Belgium, Israel, and Vietnam. Of the included studies, there were two randomised controlled trials (RCTs) and the rest were observational studies. Existing evidence suggests that vaccinations administered during 19–37 weeks of gestation are associated with significantly increased antibody levels in the blood of both mothers and their newborns at birth compared to placebo or no vaccination. However, there is a lack of robust evidence to suggest whether these increased antibodies can also reduce the incidence of pertussis (one RCT, n = 48, no incidence in either group) and pertussis-related severe complications (one observational study) or mortality (no study) in infants. Meanwhile, there is no evidence of increased risk of serious complications such as stillbirth (e.g. one RCT, n = 103, RR = 0, meaning no case in the vaccine group), or preterm birth (two RCTs, n = 151, RR = 0.86, 95%CI: 0.14–5.21) related to administration of the vaccine during pregnancy.

Conclusion

Given that pertussis infection is increasing in many countries and that newborn babies are at greatest risk of developing severe complications from pertussis, maternal vaccination in the later stages of pregnancy should continue to be supported while further research should fill knowledge gaps and strengthen evidence of its efficacy and safety.
Appendix
Available only for authorised users
Literature
1.
2.
Leuridan E, Hens N, Peeters N, de Witte L, Van der Meeren O, Van Damme P. Effect of a prepregnancy pertussis booster dose on maternal antibody titers in young infants. Pediatr Infect Dis J. 2011;30(7):608–10.CrossRefPubMed
3.
4.
5.
Gall SA, Myers J, Pichichero M. Maternal immunization with tetanus-diphtheria-pertussis vaccine: effect on maternal and neonatal serum antibody levels. Am J Obstet Gynecol. 2011;204(4):334.e1–335.CrossRef
6.
Halperin BA, Halperin SA. The reemergence of pertussis and infant deaths: is it time to immunize pregnant women? Future Microbiol. 2011;6(4):367–9.CrossRefPubMed
7.
Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women--advisory committee on immunization practices (ACIP). MMWR Morb Mortal Wkly Rep 2013. 2012;62(7):131–5.
8.
9.
Koepke R, Kahn D, Petit AB, Schauer SL, Hopfensperger DJ, Conway JH, Davis JP. Pertussis and influenza vaccination among insured pregnant women - Wisconsin, 2013-2014. MMWR Morb Mortal Wkly Rep. 2015;64(27):746–50.PubMed
10.
Maertens K, Braeckman T, Top G, Van Damme P, Leuridan E. Maternal pertussis and influenza immunization coverage and attitude of health care workers towards these recommendations in Flanders. Belgium Vaccine. 2016;34(47):5785–91.CrossRefPubMed
11.
Robles A, Valez A, Olivieri P, Chambliss L. Tdap administration in pregnancy: examining adherence to guidelines. Reprod Sci. 2015;22:349A.
12.
MacDougall DM, Halperin BA, Langley JM, McNeil SA, MacKinnon-Cameron D, Li L, Halperin SA. Knowledge, attitudes, beliefs, and behaviors of pregnant women approached to participate in a Tdap maternal immunization randomized, controlled trial. Hum Vaccin Immunother. 2016;12(4):879–85.CrossRefPubMedPubMedCentral
13.
Dempsey AF, Brewer SE, Sevick C, Pyrzanowski J, Mazzoni S, O'Leary ST. Tdap vaccine attitudes and utilization among pregnant women from a high-risk population. Hum Vaccin Immunother. 2016;12(4):872–8.CrossRefPubMed
14.
Chamberlain AT, Seib K, Ault KA, Orenstein WA, Frew PM, Malik F, Cortes M, Cota P, Whitney EA, Flowers LC, et al. Factors associated with intention to receive influenza and tetanus, diphtheria, and Acellular Pertussis (Tdap) vaccines during pregnancy: a focus on vaccine hesitancy and perceptions of disease severity and vaccine safety. PLoS Curr. 2015;7
15.
Bonville CA, Cibula DA, Domachowske JB, Suryadevara M. Vaccine attitudes and practices among obstetric providers in New York state following the recommendation for pertussis vaccination during pregnancy. Hum Vaccin Immunother. 2015;11(3):713–8.CrossRefPubMedPubMedCentral
16.
Amirthalingam G, Andrews N, Campbell H, Ribeiro S, Kara E, Donegan K, Fry NK, Miller E, Ramsay M. Effectiveness of maternal pertussis vaccination in England: an observational study. Lancet. 2014;384(9953):1521–8.CrossRefPubMed
17.
Sukumaran L, McCarthy NL, Kharbanda EO, McNeil MM, Naleway AL, Klein NP, Jackson ML, Hambidge SJ, Lugg MM, Li R, et al. Association of Tdap Vaccination with Acute Events and Adverse Birth Outcomes among Pregnant Women with Prior Tetanus-Containing Immunizations. JAMA. 2015;314(15):1581–7.CrossRefPubMed
18.
Sukumaran L, McCarthy NL, Kharbanda EO, Weintraub ES, Vazquez-Benitez G, McNeil MM, Li R, Klein NP, Hambidge SJ, Naleway AL, et al. Safety of tetanus Toxoid, reduced diphtheria Toxoid, and Acellular Pertussis and influenza vaccinations in pregnancy. Obstet Gynecol. 2015;126(5):1069–74.CrossRefPubMedPubMedCentral
19.
Faucette AN, Pawlitz MD, Pei B, Yao F, Chen K. Immunization of pregnant women: future of early infant protection. Hum Vaccin Immunother. 2015;11(11):2549–55.CrossRefPubMedPubMedCentral
20.
21.
Higgins J, Green SP. Cochrane handbook for systematic reviews of interventions. Oxford: Wiley-Blackwell; 2011.
22.
Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, Guyatt GH, Harbour RT, Haugh MC, Henry D, et al. Grading quality of evidence and strength of recommendations. BMJ. 2004;328(7454):1490.CrossRefPubMed
23.
Bland M: An introduction to medical statistics; 2000.
24.
Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway A, Omer SB, Hambidge SJ, Lee GM, Jackson ML, et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA. 2014;312(18):1897–904.CrossRefPubMed
25.
Kharbanda EO, Vazquez-Benitez G, Lipkind HS, Klein NP, Cheetham TC, Naleway AL, Lee GM, Hambidge S, Jackson ML, Omer SB, et al. Maternal Tdap vaccination: coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013. Vaccine. 2016;34(7):968–73.CrossRefPubMed
26.
Abu Raya B, Srugo I, Kessel A, Peterman M, Bader D, Gonen R, Bamberger E. The effect of timing of maternal tetanus, diphtheria, and acellular pertussis (Tdap) immunization during pregnancy on newborn pertussis antibody levels - a prospective study. Vaccine. 2014;32(44):5787–93.CrossRefPubMed
27.
Abu Raya B, Srugo I, Kessel A, Peterman M, Bader D, Peri R, Ashtamker N, Gonen R, Bamberger E. The induction of breast milk pertussis specific antibodies following gestational tetanus-diphtheria-acellular pertussis vaccination. Vaccine. 2014;32(43):5632–7.CrossRefPubMed
28.
De Schutter S, Maertens K, Baerts L, De Meester I, Van Damme P, Leuridan E. Quantification of vaccine-induced antipertussis toxin secretory IgA antibodies in breast milk: comparison of different vaccination strategies in women. Pediatr Infect Dis J. 2015;34(6):e149–52.CrossRefPubMed
29.
Maertens K, Cabore RN, Huygen K, Hens N, Van Damme P, Leuridan E. Pertussis vaccination during pregnancy in Belgium: results of a prospective controlled cohort study. Vaccine. 2016;34(1):142–50.CrossRefPubMed
30.
Hoang HT, Leuridan E, Maertens K, Nguyen TD, Hens N, Vu NH, Cabore RN, Duong HT, Huygen K, Van Damme P, et al. Pertussis vaccination during pregnancy in Vietnam: results of a randomized controlled trial Pertussis vaccination during pregnancy. Vaccine. 2016;34(1):151–9.CrossRefPubMed
31.
Munoz FM, Bond NH, Maccato M, Pinell P, Hammill HA, Swamy GK, Walter EB, Jackson LA, Englund JA, Edwards MS, et al. Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA. 2014;311(17):1760–9.CrossRefPubMedPubMedCentral
32.
33.
Hardy-Fairbanks AJ, Pan SJ, Decker MD, Johnson DR, Greenberg DP, Kirkland KB, Talbot EA, Bernstein HH. Immune responses in infants whose mothers received Tdap vaccine during pregnancy. Pediatr Infect Dis J. 2013;32(11):1257–60.CrossRefPubMed
34.
Healy CM, Rench MA, Baker CJ. Importance of timing of maternal combined tetanus, diphtheria, and acellular pertussis (Tdap) immunization and protection of young infants. Clin Infect Dis. 2013;56(4):539–44.CrossRefPubMed
35.
Ladhani SN, Andrews NJ, Southern J, Jones CE, Amirthalingam G, Waight PA, England A, Matheson M, Bai X, Findlow H, et al. Antibody responses after primary immunization in infants born to women receiving a pertussis-containing vaccine during pregnancy: single arm observational study with a historical comparator. Clin Infect Dis. 2015;61(11):1637–44.CrossRefPubMed
36.
Shakib JH, Korgenski K, Sheng X, Varner MW, Pavia AT, Byington CL. Tetanus, diphtheria, acellular pertussis vaccine during pregnancy: pregnancy and infant health outcomes. J Pediatr. 2013;163(5):1422-6.e1–4.CrossRef
37.
Dabrera G, Amirthalingam G, Andrews N, Campbell H, Ribeiro S, Kara E, Fry NK, Ramsay M. A case-control study to estimate the effectiveness of maternal pertussis vaccination in protecting newborn infants in England and Wales, 2012-2013. Clin Infect Dis. 2015;60(3):333–7.CrossRefPubMed
38.
Katz MH. Study design and statistical analysis : a practical guide for clinicians. Cambridge: Cambridge University Press; 2006.CrossRef
39.
40.
41.
Halasa NB, O'Shea A, Shi JR, LaFleur BJ, Edwards KM. Poor immune responses to a birth dose of diphtheria, tetanus, and acellular pertussis vaccine. J Pediatr. 2008;153(3):327–32.CrossRefPubMedPubMedCentral
42.
Jones C, Pollock L, Barnett SM, Battersby A, Kampmann B. Specific antibodies against vaccine-preventable infections: a mother-infant cohort study. BMJ Open. 2013;3(4):e002473. doi:10.​1136/​bmjopen-2012-002473.
43.
Amirthalingam G, Campbell H, Ribeiro S, Fry NK, Ramsay M, Miller E, Andrews N. Sustained effectiveness of the maternal Pertussis immunization program in England 3 years following introduction. Clin Infect Dis. 2016;63(suppl 4):S236–43.CrossRefPubMedPubMedCentral
44.
45.
Jones CE, Munoz FM, Kochhar S, Vergnano S, Cutland CL, Steinhoff M, Black S, Heininger U, Bonhoeffer J, Heath PT. Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy. Vaccine. 2016;34(49):6007–14.CrossRefPubMedPubMedCentral
46.
Jones CE, Munoz FM, Spiegel HM, Heininger U, Zuber PL, Edwards KM, Lambach P, Neels P, Kohl KS, Gidudu J, et al. Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women. Vaccine. 2016;34(49):5998–6006.CrossRefPubMedPubMedCentral
47.
Munoz FM, Eckert LO, Katz MA, Lambach P, Ortiz JR, Bauwens J, Bonhoeffer J. Key terms for the assessment of the safety of vaccines in pregnancy: results of a global consultative process to initiate harmonization of adverse event definitions. Vaccine. 2015;33(47):6441–52.CrossRefPubMed
48.
Metadata
Title
Efficacy and safety of pertussis vaccination for pregnant women – a systematic review of randomised controlled trials and observational studies
Authors
Marie Furuta
Jacqueline Sin
Edmond S. W. Ng
Kay Wang
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2017
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-017-1559-2

Other articles of this Issue 1/2017

BMC Pregnancy and Childbirth 1/2017 Go to the issue

Research article

Institutional maternal and perinatal deaths: a review of 40 low and middle income countries

Research article

Pregnant women’s preferences for and concerns about preterm birth prevention: a cross-sectional survey

Research article

Survey of maternal sleep practices in late pregnancy in a multi-ethnic sample in South Auckland, New Zealand

Research article

“The co-authors of pregnancy”: leveraging men’s sense of responsibility and other factors for male involvement in antenatal services in Kinshasa, DRC

Research article

Association between infection and fever in terminations of pregnancy using misoprostol: a retrospective cohort study

Research article

Examining the provisional guidelines for weight gain in twin pregnancies: a retrospective cohort study