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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 February 2013
Main ID:  NCT01306682
Date of registration: 01/03/2011
Primary sponsor: University of Witwatersrand, South Africa
Public title: Influenza Vaccination of HIV Infected Pregnant Women: Safety and Immunogenicity MatfluHIVpos
Scientific title: Trivalent Influenza Vaccine in HIV-infected Pregnant Women and Kinetics of Transplacental Anti-influenza Antibody Transfer and Persistence in Young Infants: A Randomized Controlled Phase II Trial Evaluating Safety and Immunogenicity
Date of first enrolment: March 2011
Target sample size: 194
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01306682
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Countries of recruitment
South Africa
Contacts
Name:   Keith P Klugman, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Emory University
Name:   Adriana Weinberg, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Colorado, Denver
Name:   Shabir A Madhi, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  University of the Witwatersrand
Key inclusion & exclusion criteria

Inclusion Criteria:

- Pregnant women age > 18 years to < 39 years.

- Gestational age = 20 weeks to < 34 weeks documented by the approximate date of the
last menstrual period and corroborated by physical exam.

- Documented to be HIV-infected on two assays prior to study-enrollment.

- Able to understand and comply with planned study procedures.

- Provides written informed consent prior to initiation of study.

Exclusion Criteria

- In HIV-infected women features of WHO clinical category 3 or 4 of AIDS at the time of
enrollment.

- 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 inactivated licensed 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, 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 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 corticosteroids for preterm labor = 14 days before study entry.(ix)
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 IL2, 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 (systolic blood pressure = 140 and/or diastolic blood pressure = 90 mm
Hg) or pre-eclampsia



Age minimum: 18 Years
Age maximum: 39 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Influenza
Intervention(s)
Biological: Normal saline
Biological: Trivalent influenza vaccine
Primary Outcome(s)
Humoral immune responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in HIV-infected pregnant women vaccinated between 20-34 weeks of gestational age [Time Frame: 1 month post vaccination, delivery (+7 days), 24 weeks post delivery]
The proportion of newborns born to HIV-infected mothers with hemagglutination inhibition (HAI) antibody titers of =1:40 to TIV strain will be determined and compared to newborns born to TIV-vaccinated HIV-uninfected women (parallel trial) [Time Frame: Delivery (+7 days)]
Secondary Outcome(s)
CD4+ and HIV-viral load will be measured at baseline and one-month post vaccination to evaluate effect of TIV. [Time Frame: 1 month post vaccination]
Cell-mediated immune (CMI) responses to influenza strains in the vaccine will be measured to define CMI responses to TIV in HIV infected pregnant women [Time Frame: 1 month post vaccination]
Hemagglutinin (HA) antibody measurements in blood taken from mother and infants up to 24 weeks post delivery will be used to assess dynamics and kinetics of transplacentally acquired antibodies [Time Frame: 24 weeks post partum]
The number of laboratory-confirmed influenza illnesses and clinical ILI cases in maternal participants during pregnancy and for 24 weeks post-partum will be used to assess efficacy of TIV against laboratory confirmed and clinical ILI [Time Frame: 24 weeks]
The number of laboratory-confirmed or clinical influenza like illness cases in infants born to HIV infected mothers who received TIV or placebo will be used to determine efficacy of TIV vaccination of pregnant women against ILI in their infants [Time Frame: 24 weeks of age]
Secondary ID(s)
Maternal_flu_HIVpos_101107
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bill and Melinda Gates Foundation
Emory University
University of Colorado, Denver
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