Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Non-pregnant HIV-Uninfected Women: An Open Label Trial
Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Non-pregnant HIV-Uninfected Women: An Open Label Trial
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.
Inclusion Criteria:
Inclusion Criteria: All women
(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.
Inclusion Criteria: pregnant women
(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.
Exclusion Criteria:
Exclusion Criteria: All women
(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.
Exclusion Criteria: pregnant women
(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.
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