Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Nonpregnant HIV Uninfected Women

NCT01816464 | Completed Phase 4 DMC

• 1 other identifier: MatFlu_HIVneg_preg+nonpreg
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in HIV-uninfected pregnant women compared with HIV-uninfected non-pregnant women in 2013. Safety data will also be collected.THe Pregnancy outcomes and the transplacental transfer of antibodies will also be assessed.

Conditions

Influenza

Keywords

Influenza; Vaccination

Outcome Measures

Primary Outcomes (2)

• Compare the immunogenicity of Trivalent Influenza Vaccine (TIV) in pregnant compared to non-pregnant Human Immunodeficiency Virus (HIV)-uninfected women.

  Hemagglutination inhibition assays (HAI)will be performed to assess the immunogenicity of TIV. In this study we will use the following definitions to assess the humoral immune response to TIV: HAI titers \<1:10 = seronegative; HAI titers ≥1:10 = seropositive; HAI titers ≥1:40 = sero-protective titers; and sero-conversion will be defined as HAI titers from \<1:10 to ≥1:40 or ≥4-fold increase if pre-vaccination titers were ≥1:10.

  one month post-vaccination

• Evaluate the immunogenicity of Trivalent Influenza Vaccine (TIV) in pregnant Human Immunodeficiency Virus (HIV)-uninfected women at time of delivery

  Hemagglutination inhibition assays (HAI)will be performed to assess the immunogenicity of TIV. In this study we will use the following definitions to assess the humoral immune response to TIV: HAI titers \<1:10 = seronegative; HAI titers ≥1:10 = seropositive; HAI titers ≥1:40 = sero-protective titers; and sero-conversion will be defined as HAI titers from \<1:10 to ≥1:40 or ≥4-fold increase if pre-vaccination titers were ≥1:10.

  one week post delivery for the pregnant cohort

Secondary Outcomes (7)

• Determine the impact of vaccination on T-cell activation and regulatory B and T cells subpopulations in pregnant and non-pregnant women.

  one month post vaccination and one week post delivery in pregnant cohort

• 2.2.2. Determine the impact of vaccination on cell-mediated immune responses to each influenza strain in HIV-uninfected pregnant and non-pregnant women

  one month post vaccination

• Determine the dynamics of transplacental transfer of maternal Hemagglutinin (HA) antibodies to their newborns.

  one week post delivery in pregnant cohort

• Determine antibodies against TIV present in breast milk

  in week post delivery

• Compare local and systemic solicited reactions to TIV in pregnant and non-pregnant HIV-uninfected women.

  one month post vaccination

Study Arms (1)

Trivalent Influenza Vaccine

EXPERIMENTAL

The formulation based on the WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains: * an A/California/7/2009 (H1N1)pdm09-like virus; * an A/Victoria/361/2011 (H3N2)-like virus; * a B/Wisconsin/1/2010-like virus. Dose: Single Dose 0.5 mL of TIV from pre-filled syringe.

Biological: Trivalent Influenza Vaccine

Interventions

Trivalent Influenza Vaccine BIOLOGICAL

The formulation based on the WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains: * an A/California/7/2009 (H1N1)pdm09-like virus; * an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus. The vaccine to be used in the study in 2013 is Vaxigrip (Sanofi Pasteur), or other equivalent licensed vaccine should the latter not be available, which will be procured commercially in pre-filled syringes. Using aseptic technique, participants will be injected with 0.5 mL of TIV from pre-filled syringe.

Also known as: Vaxigrip

Trivalent Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (i) Documented to be HIV-1 uninfected on one assay used in the Prevention of Mother to Child Transmission (PMTCT)/ other program undertaken within 12 weeks of study enrolment.
• (ii) Able to understand and comply with planned study procedures. (iii) Provides written informed consent prior to initiation of study. (iv) Women age ≥ 18 years to \< 39 years.
• (i) Gestational age ≥20 weeks to \<36 weeks documented by the approximate date of the last menstrual period and corroborated by physical exam and sonar report if available.

You may not qualify if:

• (i) Receipt of TIV, other than through the study, during the current influenza season documented by medical history or record.
• (ii) Receipt of any live licensed vaccine ≤ 28 days or any other vaccine (except for tetanus toxoid vaccine) ≤ 14 days prior to study-vaccine.
• (iii) Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, or expects to receive another non-licensed agent before delivery unless study approval is obtained.
• (iv) Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 38 degrees C ≤ 24 hours prior to study entry.
• (v) Use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or has immunosuppression as a result of an underlying illness or treatment.
• (vi) Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤ 12 weeks of study entry, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) ≤ 12 weeks before study entry (nasal and topical steroids are allowed).
• (vii) Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤ 12 weeks prior to enrollment in this study or is scheduled to receive immunoglobulin or other blood products (with the exception of Rho D immune globulin) during pregnancy or for the first 24 weeks after delivery.
• (viii) Receipt of immune mediators ≤ 12 weeks before enrollment. (ix) Uncontrolled major psychiatric disorder. (x) History of a severe adverse reaction to previous TIV. (xi) Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
• (i) Receipt of corticosteroids for preterm labor ≤ 14 days before study entry. (ii) Pregnancy complications (in the current pregnancy) such as pre-term labor, hypertension (Blood Pressure (BP) \>140/90 in the presence of proteinuria or BP \>150/100, with or without proteinuria or currently on antihypertensive medication) or pre-eclampsia.

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Nrf/Dst Vpd Rmpru

Soweto, GP, 2055, South Africa

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; vaxigrip

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Shabir A Madhi, PHD

  University of Witwatersrand, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 22, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 12, 2015

Record last verified: 2015-01

Locations

ZA (1)