Status:
COMPLETED
Immunogenicity and Safety of Different Dosing Schedules of Trivalent Influenza Vaccine in HIV-infected Pregnant Women
Lead Sponsor:
University of Witwatersrand, South Africa
Conditions:
Influenza
Eligibility:
FEMALE
18-39 years
Phase:
PHASE3
Brief Summary
The overall aim of this project is to evaluate the safety and immunogenicity of 3 different dosing options of trivalent influenza vaccine (TIV) vaccination of HIV-infected pregnant women: single dose,...
Detailed Description
Determining the contribution of influenza to early childhood morbidity and mortality in sub-Saharan Africa and the potential to prevent influenza disease through vaccination may contribute to reducing...
Eligibility Criteria
Inclusion
- Pregnant women age under 18 years to under 39 years.
- Gestational age greater or equal 12 weeks to under 36 weeks documented by the approximate date of the last menstrual period and corroborated by physical/ sonar examination.
- Documented to be HIV-infected on two assays prior to study-enrolment.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of study.
Exclusion
- Features of WHO clinical category 3 or 4 of AIDS at the time of enrolment.
- Receipt of TIV, other than through the study, during the current influenza season documented by medical history or record.
- Receipt of any live licensed vaccine 28 days or less or inactivated licensed vaccine (EXCEPT tetanus toxoid) 14 days or less prior to study-vaccine.
- Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) 28 days or less prior to vaccination in this study, or expects to receive another non-licensed agent before delivery 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 Celcius ≤ 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 corticosteroids for preterm labor ≤ 14 days before study entry.
- 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.
- Receipt of interleucin 2 (IL2), interferon (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.
- Pregnancy complications (in the current pregnancy) such as pre-term labor, hypertension (BP \>140/90 in the presence of proteinuria or BP \>150/100, with or without proteinuria or currently on antihypertensive medication) and pre-eclampsia.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT01527825
Start Date
September 1 2012
End Date
June 1 2014
Last Update
January 12 2015
Active Locations (1)
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1
Respiratory and Meningeal Pathogens research unit
Soweto, Johannesburg, Gauteng, South Africa, 2013