Flor M Munoz1, Lisa A Jackson2, Geeta K Swamy3, Kathryn M Edwards4, Sharon E Frey5, Ina Stephens6, Kevin Ault7, Patricia Winokur8, Carey R Petrie9, Mark Wolff9, Shital M Patel10, Wendy A Keitel10. 1. Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA. Electronic address: florm@bcm.edu. 2. Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. 3. Department of Obstetrics & Gynecology, Duke University, Durham, NC, USA. 4. Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University, Nashville, TN, USA. 5. Saint Louis University School of Medicine, St. Louis, MO, USA. 6. Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD, USA. 7. Emory University Department of Gynecology and Obstetrics and the Emory Vaccine Center, Atlanta, GA, USA. 8. University of Iowa, Iowa City, IA, USA. 9. The Emmes Corporation, Rockville, MD, USA. 10. Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA; Departments of Medicine, Baylor College of Medicine, Houston, TX, USA.
Abstract
BACKGROUND: In the United States, seasonal inactivated influenza vaccine (IIV) is recommended for pregnant women; however, in early 2009, immunization rates were low, partly due to limited prospective data and concerns about vaccine safety. OBJECTIVE: We conducted a randomized study of two licensed seasonal trivalent IIVs (IIV3) to assess their safety and immunogenicity in pregnant women. STUDY DESIGN: In this prospective, randomized clinical study, 100 pregnant women, 18-39 years of age and ≥14 weeks gestation received asingle intramuscular dose of 2008-2009 Fluzone® or Fluarix®. Injection site and systemic reactions were recorded for 7 days after vaccination and serious adverse events (SAEs) and pregnancy outcomes were documented. Serum samples collected before and 28 days after vaccination were tested for hemagglutination inhibition (HAI) antibody levels. RESULTS: The majority of the injection site and systemic reactions were mild and self-limited after both vaccines. No fever ≥100 °F was reported. There were no vaccine-associated SAEs. Immune responses to influenza vaccine antigens were similar for the two study vaccines, with robust HAI responses against influenza A strains, and relatively lower responses for influenza B strains. CONCLUSION:Seasonal inactivated influenza vaccines were well tolerated and immunogenic in pregnant women. SYNOPSIS: In this prospective clinical trial, we demonstrated that immunization with seasonal trivalent, inactivated influenza vaccine in the second and third trimester of pregnancy is immunogenic and safe.
RCT Entities:
BACKGROUND: In the United States, seasonal inactivated influenza vaccine (IIV) is recommended for pregnant women; however, in early 2009, immunization rates were low, partly due to limited prospective data and concerns about vaccine safety. OBJECTIVE: We conducted a randomized study of two licensed seasonal trivalent IIVs (IIV3) to assess their safety and immunogenicity in pregnant women. STUDY DESIGN: In this prospective, randomized clinical study, 100 pregnant women, 18-39 years of age and ≥14 weeks gestation received a single intramuscular dose of 2008-2009 Fluzone® or Fluarix®. Injection site and systemic reactions were recorded for 7 days after vaccination and serious adverse events (SAEs) and pregnancy outcomes were documented. Serum samples collected before and 28 days after vaccination were tested for hemagglutination inhibition (HAI) antibody levels. RESULTS: The majority of the injection site and systemic reactions were mild and self-limited after both vaccines. No fever ≥100 °F was reported. There were no vaccine-associated SAEs. Immune responses to influenza vaccine antigens were similar for the two study vaccines, with robust HAI responses against influenza A strains, and relatively lower responses for influenza B strains. CONCLUSION: Seasonal inactivated influenza vaccines were well tolerated and immunogenic in pregnant women. SYNOPSIS: In this prospective clinical trial, we demonstrated that immunization with seasonal trivalent, inactivated influenza vaccine in the second and third trimester of pregnancy is immunogenic and safe.
Authors: Lyndsay A Avalos; Jeannette Ferber; Ousseny Zerbo; Allison L Naleway; Joanna Bulkley; Mark Thompson; Janet Cragan; Jennifer Williams; Roxana Odouli; Tia L Kauffman; Sarah Ball; Pat Shifflett; De-Kun Li Journal: Vaccine Date: 2020-02-05 Impact factor: 3.641
Authors: Tazio Vanni; Beatriz da Costa Thomé; Mayra Martho Moura de Oliveira; Vera Lúcia Gattás; Maria da Graça Salomão; Marcelo Eiji Koike; Maria Beatriz Bastos Lucchesi; Patrícia Emília Braga; Roberta de Oliveira Piorelli; Juliana Yukari Koidara Viscondi; Gabriella Mondini; Anderson da Silva; Heloísa Maximo Espínola; Joane do Prado Santos; Samanta Hosokawa Dias de Nóvoa Rocha; Lily Yin Weckx; Olga Menang; Muriel Soquet; Alexander Roberto Precioso Journal: PLoS One Date: 2021-02-11 Impact factor: 3.240