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

NCT01812980 | Completed Phase 4 DMC

• 1 other identifier: MatFlu_HIVpos_nonpregnant
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza; Human Immunodeficiency Virus

Keywords

Influenza; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Immunogenicity of Trivalent Influenza Vaccine (TIV)by measuring Hemagglutination Inhibition Assays (HAI)

  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.

  one month post vaccination

Secondary Outcomes (4)

• impact of vaccination on T-cell activation and on T- and B-cell subpopulations

  one month post vaccination

• Impact of Vaccination of Cell Mediated Immune (CMI) Responses

  one month post vaccination

• Local and Systemic solicited reactions to TIV

  1 week and one month post vaccination

• safety outcome measures of TIV

  within one month post vaccination

Study Arms (1)

Trivalent Inactivated Influenza Vaccine

EXPERIMENTAL

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

Interventions

Trivalent Inactivated Influenza Vaccine BIOLOGICAL

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.

Also known as: Vaxigrip

Trivalent Inactivated 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Nrf/Dst Vpd Rmpru

Soweto, Gauteng, South Africa

Location

MeSH Terms

Conditions

Influenza, Human; Acquired Immunodeficiency Syndrome

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

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 13, 2013
• First Posted: March 18, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

ZA (1)