Clinical trial NCT01816464: Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Nonpregnant HIV Uninfected Women
Official title: Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Non-pregnant HIV-Uninfected Women: An Open Label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Vaccination
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2013-03-22
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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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Primary outcomes:
measure: Compare the immunogenicity of Trivalent Influenza Vaccine (TIV) in pregnant compared to non-pregnant Human Immunodeficiency Virus (HIV)-uninfected women.
timeFrame: one month post-vaccination
measure: Evaluate the immunogenicity of Trivalent Influenza Vaccine (TIV) in pregnant Human Immunodeficiency Virus (HIV)-uninfected women at time of delivery
timeFrame: one week post delivery for the pregnant cohort
Secondary outcomes:
measure: Determine the impact of vaccination on T-cell activation and regulatory B and T cells subpopulations in pregnant and non-pregnant women.
timeFrame: one month post vaccination and one week post delivery in pregnant cohort
measure: 2.2.2. Determine the impact of vaccination on cell-mediated immune responses to each influenza strain in HIV-uninfected pregnant and non-pregnant women
timeFrame: one month post vaccination
measure: Determine the dynamics of transplacental transfer of maternal Hemagglutinin (HA) antibodies to their newborns.
timeFrame: one week post delivery in pregnant cohort
measure: Determine antibodies against TIV present in breast milk
timeFrame: in week post delivery
measure: Compare local and systemic solicited reactions to TIV in pregnant and non-pregnant HIV-uninfected women.
timeFrame: one month post vaccination
measure: Describe safety outcome measures (maternal and foetal) of TIV-vaccination of HIV-uninfected pregnant women.
timeFrame: one month post vaccination and one week post delivery in pregnant cohort
measure: Describe obstetric outcomes in HIV-uninfected pregnant women who received TIV
timeFrame: one week post delivery in pregnant cohort
Other outcomes:
Locations:
city: Soweto
country: South Africa
facility: Nrf/Dst Vpd Rmpru
state: GP
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Shabir A Madhi, PHD
role: PRINCIPAL_INVESTIGATOR
References: