Immunogenicity and Safety of Trivalent Influenza Vaccine... | NCT01812980

NCT01812980

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Bill and Melinda Gates Foundation	OTHER

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
impact of vaccination on T-cell activation and on T- and B-cell subpopulations	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.	one month post vaccination

Eligibility Module

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.
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.

ID	Term
D007251	Influenza, Human
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections