NK Cell Mediated Influenza Immunity During Pregnancy

NCT03196245 | Terminated

• 1 other identifier: IRB-25182
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnant women have increased morbidity and mortality due to infection with influenza. Changes in T cell function have been proposed as possible mechanisms for this finding. We believe that pregnancy induced changes in NK cell phenotype and function also impact influenza immunity. This study will compare the immune response of pregnant women and controls to TIV influenza vaccination as a surrogate for infection. In addition pregnant women with flu like illness will be enrolled to evaluate changes in immune response following influenza infection as compared to vaccination.

Conditions

Pregnancy Related; Influenza, Human

Outcome Measures

Primary Outcomes (1)

• NK cell function

  We are assessing the NK cell repertoire and anti-influenza NK cell function

  2 years

Study Arms (1)

Pregnant women

Pregnant women undergoing influenza vaccination or acutely infected with influenza

Other: There is no intervention.

Interventions

There is no intervention. OTHER

There is no intervention. This is a purely observational study. We enrolled pregnant women as they received a vaccine as part of their regular medical care; we did not administer the vaccine. We also enrolled pregnant women acutely infected with influenza.

Pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: We enrolled only pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We enrolled a cohort of 94 healthy pregnant women from the Lucille Packard Children's Hospital Obstetrics Clinic from 2012-2016. Women will be enrolled during their 2nd and 3rd trimesters following administration of the TIV influenza vaccine which is the standard of care for pregnant women.

You may qualify if:

• Pregnant women (18-42 years of age)
• Pregnant women planning to receive the TIV seasonal influenza vaccine or Pregnant women presenting with influenza like illness

You may not qualify if:

• Oral immunosuppressive agents (inhaled steroids OK)
• Serious chronic illness including autoimmune disease or chronic viral infections (eg, systemic lupus erythematosis,HIV, hepatitis B or C)
• Malignancy or blood dyscrasia
• Type I or II diabetes or morbid obesity (pre-pregnancy BMI\>40)(gestational diabetes ok)
• Presence of fetal cardiac abnormalities
• Receipt of blood or blood products within the last year
• Prior receipt of current seasonal influenza vaccine for influenza vaccine arm
• History of egg allergy for influenza vaccine arm

Sponsors & Collaborators

• Stanford University: lead
• Doris Duke Charitable Foundation: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (5)

• Le Gars M, Seiler C, Kay AW, Bayless NL, Starosvetsky E, Moore L, Shen-Orr SS, Aziz N, Khatri P, Dekker CL, Swan GE, Davis MM, Holmes S, Blish CA. Pregnancy-Induced Alterations in NK Cell Phenotype and Function. Front Immunol. 2019 Oct 23;10:2469. doi: 10.3389/fimmu.2019.02469. eCollection 2019.

  PMID: 31708922 BACKGROUND

• Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.

  PMID: 27655870 RESULT

• Kay AW, Blish CA. Immunogenicity and Clinical Efficacy of Influenza Vaccination in Pregnancy. Front Immunol. 2015 Jun 4;6:289. doi: 10.3389/fimmu.2015.00289. eCollection 2015.

  PMID: 26089824 RESULT

• Kay AW, Bayless NL, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Blish CA. Pregnancy Does Not Attenuate the Antibody or Plasmablast Response to Inactivated Influenza Vaccine. J Infect Dis. 2015 Sep 15;212(6):861-70. doi: 10.1093/infdis/jiv138. Epub 2015 Mar 4.

  PMID: 25740957 RESULT

• Kay AW, Fukuyama J, Aziz N, Dekker CL, Mackey S, Swan GE, Davis MM, Holmes S, Blish CA. Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proc Natl Acad Sci U S A. 2014 Oct 7;111(40):14506-11. doi: 10.1073/pnas.1416569111. Epub 2014 Sep 22.

  PMID: 25246558 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

We have peripheral blood mononuclear cells and plasma from a small number of subjects banked for future assessment of immunologic function, as specified in our consent.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: August 14, 2012
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)