Research on vaccines during pregnancy: Protocol design and assessment of safety

Flor M. Munoz, Jeanne S. Sheffield, Richard H. Beigi, Jennifer S. Read, Geeta K. Swamy, Indira Jevaji, Sonja A. Rasmussen, Kathryn M. Edwards, Kimberly Fortner, Shital M. Patel, Catherine Y. Spong, Kevin Ault, R. Philips Heine, Mirjana Nesin

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.

Original languageEnglish (US)
Pages (from-to)4274-4279
Number of pages6
JournalVaccine
Volume31
Issue number40
DOIs
StatePublished - Sep 13 2013

Fingerprint

safety assessment
clinical trials
Vaccines
Clinical Trials
pregnancy
vaccines
Safety
Pregnancy
pregnant women
Research
infectious diseases
Pregnant Women
National Institute of Allergy and Infectious Diseases (U.S.)
Research Personnel
National Institutes of Health
National Institutes of Health (U.S.)
microbiology
Microbiology
hypersensitivity
Communicable Diseases

All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Munoz, F. M., Sheffield, J. S., Beigi, R. H., Read, J. S., Swamy, G. K., Jevaji, I., ... Nesin, M. (2013). Research on vaccines during pregnancy: Protocol design and assessment of safety. Vaccine, 31(40), 4274-4279. https://doi.org/10.1016/j.vaccine.2013.07.042

Research on vaccines during pregnancy : Protocol design and assessment of safety. / Munoz, Flor M.; Sheffield, Jeanne S.; Beigi, Richard H.; Read, Jennifer S.; Swamy, Geeta K.; Jevaji, Indira; Rasmussen, Sonja A.; Edwards, Kathryn M.; Fortner, Kimberly; Patel, Shital M.; Spong, Catherine Y.; Ault, Kevin; Heine, R. Philips; Nesin, Mirjana.

In: Vaccine, Vol. 31, No. 40, 13.09.2013, p. 4274-4279.

Research output: Contribution to journalArticle

Munoz, FM, Sheffield, JS, Beigi, RH, Read, JS, Swamy, GK, Jevaji, I, Rasmussen, SA, Edwards, KM, Fortner, K, Patel, SM, Spong, CY, Ault, K, Heine, RP & Nesin, M 2013, 'Research on vaccines during pregnancy: Protocol design and assessment of safety', Vaccine, vol. 31, no. 40, pp. 4274-4279. https://doi.org/10.1016/j.vaccine.2013.07.042
Munoz FM, Sheffield JS, Beigi RH, Read JS, Swamy GK, Jevaji I et al. Research on vaccines during pregnancy: Protocol design and assessment of safety. Vaccine. 2013 Sep 13;31(40):4274-4279. https://doi.org/10.1016/j.vaccine.2013.07.042
Munoz, Flor M. ; Sheffield, Jeanne S. ; Beigi, Richard H. ; Read, Jennifer S. ; Swamy, Geeta K. ; Jevaji, Indira ; Rasmussen, Sonja A. ; Edwards, Kathryn M. ; Fortner, Kimberly ; Patel, Shital M. ; Spong, Catherine Y. ; Ault, Kevin ; Heine, R. Philips ; Nesin, Mirjana. / Research on vaccines during pregnancy : Protocol design and assessment of safety. In: Vaccine. 2013 ; Vol. 31, No. 40. pp. 4274-4279.
@article{7c3d0aa5ce8948cdbec4d62a6af0165e,
title = "Research on vaccines during pregnancy: Protocol design and assessment of safety",
abstract = "The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled {"}Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics{"}, to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.",
author = "Munoz, {Flor M.} and Sheffield, {Jeanne S.} and Beigi, {Richard H.} and Read, {Jennifer S.} and Swamy, {Geeta K.} and Indira Jevaji and Rasmussen, {Sonja A.} and Edwards, {Kathryn M.} and Kimberly Fortner and Patel, {Shital M.} and Spong, {Catherine Y.} and Kevin Ault and Heine, {R. Philips} and Mirjana Nesin",
year = "2013",
month = "9",
day = "13",
doi = "10.1016/j.vaccine.2013.07.042",
language = "English (US)",
volume = "31",
pages = "4274--4279",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "40",

}

TY - JOUR

T1 - Research on vaccines during pregnancy

T2 - Protocol design and assessment of safety

AU - Munoz, Flor M.

AU - Sheffield, Jeanne S.

AU - Beigi, Richard H.

AU - Read, Jennifer S.

AU - Swamy, Geeta K.

AU - Jevaji, Indira

AU - Rasmussen, Sonja A.

AU - Edwards, Kathryn M.

AU - Fortner, Kimberly

AU - Patel, Shital M.

AU - Spong, Catherine Y.

AU - Ault, Kevin

AU - Heine, R. Philips

AU - Nesin, Mirjana

PY - 2013/9/13

Y1 - 2013/9/13

N2 - The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.

AB - The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.

UR - http://www.scopus.com/inward/record.url?scp=84882953409&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84882953409&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2013.07.042

DO - 10.1016/j.vaccine.2013.07.042

M3 - Article

C2 - 23906888

AN - SCOPUS:84882953409

VL - 31

SP - 4274

EP - 4279

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 40

ER -