Influenza Vaccination of HIV Infected Pregnant Women: Safety and Immunogenicity (MatfluHIVpos)
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|ClinicalTrials.gov Identifier: NCT01306682|
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : February 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Trivalent influenza vaccine Biological: Normal saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: Trivalent Influenza vaccine
0.5ml of TIV will be administered into deltoid muscle of non dominant arm
Biological: Trivalent influenza vaccine
0.5 ml of trivalent influenza vaccine administered into deltoid muscle of non dominant arm
Other Name: Vaxigrip
Placebo Comparator: Normal saline
0.5ml of normal saline administered into deltoid muscle of non dominant arm
Biological: Normal saline
0.5ml normal saline administered into deltoid muscle of non dominant arm
Other Name: NaCl
- 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 ]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.
- 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) ]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
- 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 ]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
- 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 ]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.
- 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 ]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.
- 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 ]Cell mediated immunity will be measured by ELISPOT response to TIV. Blood will be collected at enrollment (pre-vaccination) and one month post vaccination
- 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 ]Evaluate the effect of TIV on CD4+ and HIV-viral load changes comparing baseline levels to one-month post vaccination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306682
|RMPRU, Chris Hani Baragwanath Hospital|
|Soweto, Johannesburg, Gauteng, South Africa, 2013|
|Study Chair:||Shabir A Madhi, MD, PhD||University of Witwatersrand, South Africa|
|Study Director:||Keith P Klugman, MD, PhD||Emory University|
|Study Director:||Adriana Weinberg, PhD||University of Colorado, Denver|