Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV-infected Women

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Michelle Groome, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:
NCT01812980
First received: March 13, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic reactions to the vaccine will also be assessed.


Condition Intervention Phase
Influenza
Human Immunodeficiency Virus
Biological: Trivalent Inactivated Influenza Vaccine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV- Infected Women: An Open Label Trial.

Resource links provided by NLM:


Further study details as provided by University of Witwatersrand, South Africa:

Primary Outcome Measures:
  • Immunogenicity of Trivalent Influenza Vaccine (TIV)by measuring Hemagglutination Inhibition Assays (HAI) [ Time Frame: one month post vaccination ] [ Designated as safety issue: No ]
    Humoral immunity will be measured by hemagglutination inhibition (HAI) assay, which has been extensively used for this purpose. In healthy individuals, HAI titers ≥1:10 indicate presence of influenza-specific antibodies and ≥1:40 protection against infection and disease. 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.


Secondary Outcome Measures:
  • impact of vaccination on T-cell activation and on T- and B-cell subpopulations [ Time Frame: one month post vaccination ] [ Designated as safety issue: No ]
    T-lymphocyte activation assays will be performed using state-of-the art polychromatic flow cytometry. The T- and B-cell phenotypes are assessed by flow cytometry using freshly thawed Peripheral Blood Mononuclear Cells (PBMC). Cells are stained using monoclonal antibodies against the comparator molecules.

  • Impact of Vaccination of Cell Mediated Immune (CMI) Responses [ Time Frame: one month post vaccination ] [ Designated as safety issue: No ]
    Interferon(IFN)Enzyme Linked Immuno Spot (ELISPOT) responses will be used to assess CMI responses to influenza vaccines.PBMCs will be separated and stimulated with influenza virus corresponding to the vaccine strains. Spots will be visualized with a ELISPOT plate reader. Results will be reported as Spot Forming Cells(SFC)/106 PBMCs.

  • Local and Systemic solicited reactions to TIV [ Time Frame: 1 week and one month post vaccination ] [ Designated as safety issue: Yes ]
    Participants will remain in the clinic for at least 30 minutes after vaccination so that clinic personnel can observe participants for any potential adverse reactions.Report of vaccine-related local (redness, swelling, tenderness, itching,) and systemic (fever, malaise, myalgia, nausea, headache, rash) adverse events will be solicited at day 7 and day 28.

  • safety outcome measures of TIV [ Time Frame: within one month post vaccination ] [ Designated as safety issue: Yes ]
    Safety and tolerability of the study vaccine will be monitored by means of Adverse Events (AEs) and toxicity reports presenting laboratory and clinical data.Toxicities will be classified by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events,


Enrollment: 105
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trivalent Inactivated Influenza Vaccine

Single dose, intramuscular injection from a pre-filled syringe

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.
Biological: Trivalent Inactivated Influenza Vaccine

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.
Other Name: Vaxigrip

Detailed Description:

Schedule of Events

Visit 1 (enrollment) Informed Consent Form (ICF) signed Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw TIV administered Diary card dispensed

Local/ systematic reactions

Visit 2: 1 month post enrolment (28-35 days) Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw Diary card collected Local/ systematic reactions reviewed

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(i) Documented to be HIV-1 infected on one assay used in the Prevention of Mother to Child Transmission (PMTCT)/ other program undertaken within 12 weeks of study enrolment.

  • Able to understand and comply with planned study procedures.
  • Provides written informed consent prior to initiation of study.
  • Not pregnant at time of enrolment (confirmed by urine testing). If pregnant in past year, participant must be at least 6 months post delivery at time of enrolment.
  • Women age ≥ 18 years to < 39 years.

Exclusion Criteria:

  • Receipt of TIV, other than through the study, during the current and previous two influenza seasons, documented by medical history or record.
  • Receipt of any live licensed vaccine ≤ 28 days or any other vaccine (except for tetanus toxoid vaccine) ≤ 14 days prior to study-vaccine.
  • Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, unless study approval is obtained.
  • 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.
  • 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.
  • 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).
  • 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.
  • Receipt of Interleukin 2, IFN, GMCSF or other immune mediators ≤ 12 weeks before enrollment.
  • Uncontrolled major psychiatric disorder.
  • History of a severe adverse reaction to previous TIV.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812980

Locations
South Africa
Nrf/Dst Vpd Rmpru
Soweto, Gauteng, South Africa
Sponsors and Collaborators
University of Witwatersrand, South Africa
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Shabir A Madhi, PHD University of Witwatersrand, South Africa
  More Information

No publications provided

Responsible Party: Michelle Groome, Investigator, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT01812980     History of Changes
Other Study ID Numbers: MatFlu_HIVpos_nonpregnant
Study First Received: March 13, 2013
Last Updated: December 10, 2013
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Witwatersrand, South Africa:
Influenza
Human Immunodeficiency Virus

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Influenza, Human
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014