Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit herpes simplex virus vaccine

Vaccine

Volumn 31, Issue 13, 2013, Pages 1759-1764

  Tavares, Fernanda ^a   Cheuvart, Brigitte ^a   Heineman, Thomas ^b   Arellano, Felix ^a   Dubin, Gary ^b  

^a GSK   (Belgium)

^b GLAXOSMITHKLINE   (United States)

Author keywords

CI; EDC; EDD; Elective abortion; Herpes simplex virus; LMP; Meta analysis; Pregnancy outcomes; RR; Spontaneous abortion

Indexed keywords

ADJUVANT; GLYCOPROTEIN D; HERPES SIMPLEX GLYCOPROTEIN D VACCINE; HERPES SIMPLEX VACCINE; UNCLASSIFIED DRUG;

ARTICLE; CLINICAL EVALUATION; CONFIDENCE INTERVAL; CONTROLLED STUDY; GENITAL HERPES; HERPES SIMPLEX VIRUS; HUMAN; INDUCED ABORTION; META ANALYSIS; PREGNANCY OUTCOME; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; SPONTANEOUS ABORTION; VACCINATION;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ALUMINUM HYDROXIDE; FEMALE; HERPES GENITALIS; HERPES SIMPLEX VIRUS VACCINES; HUMANS; LIPID A; MIDDLE AGED; PREGNANCY; PREGNANCY OUTCOME; RANDOMIZED CONTROLLED TRIALS AS TOPIC; VACCINES, SUBUNIT; YOUNG ADULT;

EID: 84875238619     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.01.002     Document Type: Article

References (25)

1. Beran J. Safety and immunogenicity of a new hepatitis B vaccine for the protection of patients with renal insufficiency including pre-haemodialysis and haemodialysis patients. Expert Opin Biol Ther 2008, 8:235-247.
2. Bernstein D.I., Aoki F.Y., Tyring S.K., Stanberry L.R., St-Pierre C., Shafran S.D., et al. Safety and immunogenicity of glycoprotein D-adjuvant genital herpes vaccine. Clin Infect Dis 2005, 40:1271-1281.
3. Cytel Software Corporation Proc-StatXact 4 for SAS Users, User Manual 1999, Cytel Software Corporation, Cambridge.
4. Descamps D., Hardt K., Spiessens B., Izurieta P., Verstraeten T., Breuer T., et al. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin 2009, 5:332-340.
5. Didierlaurent A.M., Morel S., Lockman L., Giannini S.L., Bisteau M., Carlsen H., et al. AS04, an aluminum salt- and TLR4 agonist-based adjuvant system, induces a transient localized innate immune response leading to enhanced adaptive immunity. J Immunol 2009, 183:6186-6197.
6. European Medicines Agency (Committee for Medicinal Products for Human Use) Guideline on the Exposure to Medicinal Products during Pregnancy: Need for Post-authorisation Data 2005, EMEA, London, UK.
7. Figa'-Talamanca I., Repetto F. Correcting spontaneous abortion rates for the presence of induced abortion. Am J Public Health 1988, 78:40-42.
8. Garcon N., Segal L., Tavares F., Van Mechelen M. The safety evaluation of adjuvants during vaccine development: the AS04 experience. Vaccine 2011, 29:4453-4459.
9. Goldhaber M.K., Fireman B.H. The fetal life table revisited: spontaneous abortion rates in three Kaiser Permanente cohorts. Epidemiology 1991, 2:33-39.
10. Goldhaber M.K., Fireman B.H. Re: Estimates of the annual number of clinically recognized pregnancies in the United States, 1981-1991. Am J Epidemiol 2000, 152:287-289.
11. Hammerslough C.R. Estimating the probability of spontaneous abortion in the presence of induced abortion and vice versa. Public Health Rep 1992, 107:269-277.
12. Herrero R., Hildesheim A., Rodriguez A.C., Wacholder S., Bratti C., Solomon D., et al. Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica. Vaccine 2008, 26:4795-4808.
13. National Center for Immunization and Respiratory Diseases General recommendations on immunization: recommendations of the advisory committee on immunization practices (ACIP). MMWR Recomm Rep 2011, 60:1-64.
14. Nybo Andersen A.M., Wohlfahrt J., Christens P., lsen J., Melbye M. Maternal age and fetal loss: population based register linkage study. BMJ 2000, 320:1708-1712.
15. Paavonen J., Jenkins D., Bosch F.X., Naud P., Salmerón J., Wheeler C.M., et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial. Lancet 2007, 369:2161-2170.
16. Saraiya M., Berg C.J., Shulman H., Green C.A., Atrash H.K. Estimates of the annual number of clinically recognized pregnancies in the United States, 1981-1991. Am J Epidemiol 1999, 149:1025-1029.
17. Susser E. Spontaneous abortion and induced abortion: an adjustment for the presence of induced abortion when estimating the rate of spontaneous abortion from cross-sectional studies. Am J Epidemiol 1983, 117:305-308.
18. Tavares F., Nazareth I., Monegal J.S., Kolte I., Verstraeten T., Bauchau V. Pregnancy and safety outcomes in women vaccinated with an AS03-adjuvanted split virion H1N1 (2009) pandemic influenza vaccine during pregnancy: a prospective cohort study. Vaccine 2011, 29:6358-6365.
19. Verstraeten T., Descamps D., David M.P., Zahaf T., Hardt K., Izurieta P., et al. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine 2008, 26:6630-6638.
20. Wacholder S., Chen B.E., Wilcox A., Macones G., Gonzalez P., Befano B., et al. Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ 2010, 340:c712.
21. Wilcox A.J. Surveillance of pregnancy loss in human populations. Am J Ind Med 1983, 4:285-291.
22. Wilcox A.J., Treloar A.E., Sandler D.P. Spontaneous abortion over time: comparing occurrence in two cohorts of women a generation apart. Am J Epidemiol 1981, 114:548-553.
23. Wilcox A.J., Weinberg C.R., O'Connor J.F., Baird D.D., Schlatterer J.P., Canfield R.E., et al. Incidence of early loss of pregnancy. N Engl J Med 1988, 319:189-194.
24. Zinaman M.J., Clegg E.D., Brown C.C., O'Connor J., Selevan S.G. Estimates of human fertility and pregnancy loss. Fertil Steril 1996, 65:503-509.
25. Zuccotti G., Pogliani L., Pariani E., Amendola A., Zanetti A. Transplacental antibody transfer following maternal immunization with a pandemic 2009 influenza A (H1N1) MF59-adjuvanted vaccine. JAMA 2010, 304:2360-2361.