Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV- Infected Women: An Open Label Trial.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- University of Witwatersrand, South Africa
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Immunogenicity of Trivalent Influenza Vaccine (TIV)by measuring Hemagglutination Inhibition Assays (HAI)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
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
Investigators
Michelle Groome
Investigator
University of Witwatersrand, South Africa
Eligibility 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.
Outcomes
Primary Outcomes
Immunogenicity of Trivalent Influenza Vaccine (TIV)by measuring Hemagglutination Inhibition Assays (HAI)
Time Frame: one month post vaccination
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 Outcomes
- 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)