Influenza Clinical Trial
— MatfluHIVposOfficial 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
This randomized, placebo controlled trial will evaluate the safety and immunogenicity of Trivalent Influenza Vaccine (TIV) in HIV-infected pregnant women, dynamics of transplacental anti-influenza antibody transfer to their newborns and kinetics thereof during early infancy.
Status | Completed |
Enrollment | 194 |
Est. completion date | July 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | RMPRU, Chris Hani Baragwanath Hospital | Soweto, Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
University of Witwatersrand, South Africa | Bill and Melinda Gates Foundation, Emory University, University of Colorado, Denver |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Humoral immunity will be measured by hemagglutination inhibition (HAI) assay. Blood will be collected at enrolment (pre-vaccination), one month post vaccination, delivery (+7 days) and 24 weeks post delivery. Humoral immune response definitions: HAI titers < 1:10 = seronegative; = 1:10 = seropositive; > 1:40 = protected against influenza; Response to TIV = serconversion (from <1:10 to =1:10) and/or 4-fold increase of HAI titers. | 1 month post vaccination, delivery (+7 days), 24 weeks post delivery | No |
Primary | 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) | Determine the proportion of newborns with hemagglutination inhibition (HAI) antibody titers of =1:40 to each of the three TIV strains born to HIV-infected mothers and compared to newborns born to TIV-vaccinated HIV-uninfected women | Delivery (+7 days) | No |
Secondary | 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 | Hemagglutinin (HA) antibody measurements in blood taken from mother at birth and infants at birth, 8,16 and 24 weeks post delivery will be used to assess dynamics and kinetics of transplacentally acquired antibodies | 24 weeks post partum | No |
Secondary | 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 | All infants (up to 24 weeks of age) born to women enrolled on trial will be assessed by study staff if they have any signs or symptoms (including fever, hospitalisation, apnea, cough, nasal catarrh/ congenstion, tachypnea) which could indicate influenza like illness. Nasopharyngeal aspirate samples collected at illness visits will be processed for viruses using real time reverse transcriptase-polymerase chain reaction (rRTPCR) assays. | 24 weeks of age | No |
Secondary | 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 | All maternal participants with signs and/ or symptoms of influenza like illness (ILI) will have nasopharyngeal and oropharyngeal swabs collected at illness visits and processed by rRTPCR assays. Participants from whom influenza virus is isolated at illness visits will be included in analysis to evaluate the efficacy of TIV against laboratory-confirmed influenza illness in mothers during pregnancy and until 24 weeks post-partum. Participants with no influenza isolated will be included in analysis of clinical ILI. | 24 weeks | No |
Secondary | 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 | Cell mediated immunity will be measured by ELISPOT response to TIV. Blood will be collected at enrollment (pre-vaccination) and one month post vaccination | 1 month post vaccination | No |
Secondary | CD4+ and HIV-viral load will be measured at baseline and one-month post vaccination to evaluate effect of TIV. | Evaluate the effect of TIV on CD4+ and HIV-viral load changes comparing baseline levels to one-month post vaccination. | 1 month post vaccination | Yes |
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