Safety and Immunogenicity Study of Influenza Vaccines in HIV-infected and HIV-uninfected Pregnant… (NCT01810731) | Clinical Trial Compass
WithdrawnPhase 2/3
Safety and Immunogenicity Study of Influenza Vaccines in HIV-infected and HIV-uninfected Pregnant Women in Western Kenya
Stopped: Scientific review positive from 3 manufacturers; internal committees did not support due to deploying new flu vaccines in HIV+ pregnant women in Kenya.
Kenya0Started 2014-04
Plain-language summary
In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women are the most important risk group for season influenza vaccination based upon "compelling evidence of substantial risk of severe disease in this group and evidence that seasonal influenza vaccine is safe and effective in preventing disease in pregnant women as well as their young infants, in whom disease burden is also high". Recent data from Kenya, similarly suggest rates of influenza-associated hospitalizations in children under age 1 to be as high, or higher, than those observed in the United States. However, TIV may have reduced immunogenicity in HIV-infected adults, and HIV infection has been shown to reduce placental transfer of both tetanus and measles antibodies. Therefore, we propose to conduct a double-blind randomized controlled trial of influenza vaccines stratified by HIV status in up to 720 pregnant women in their second and third trimesters and their infants residing in health and demographic surveillance sites (HDSS) in Nyanza Province, Western Kenya. We propose to assess the safety, immunogenicity, and efficacy of standard dose QIV and double dose QIV in HIV-infected and HIV-uninfected pregnant women. Findings will inform maternal influenza vaccination policies in Kenya and other African countries.
Who can participate
Age range13 Years – 49 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Resident of HDSS village
✓. Singleton pregnancy
✓. Second or third trimester (after quickening) but before 33 weeks of gestation by fundal height
✓. Does not plan to relocate out of the HDSS area or population-based surveillance site in the next 12 months and agrees to all follow-up visits/contact by phone
✓. Is not currently enrolled in another intervention study
✓. Provides informed consent by signature or thumb print
✓. Consents to HIV testing and counseling as required
✓. Willing to deliver in the labor ward of the study hospital
Exclusion criteria
✕. History of allergic reaction to any component of the study vaccines
✕. Residence outside the study area or planning to relocate out in the 9 months following enrollment
What they're measuring
1
Proportion of women with an appropriate rise in Hemagglutination Inhibition (HI) titers
Timeframe: Enrollment (Day 0) vs. Day 28 for each study arm
2
Proportion of infants born to standard dose (15 µg) QIV and double dose (30 µg) QIV recipients with HI titers greater than or equal to 40 in cord blood compared to same in controls.
Timeframe: At delivery
3
Number of solicited and unsolicited adverse events post-vaccination by study arm
Timeframe: During follow-up period, approx. 9 months
✕. Received immunoglobulin or blood products within 45 days of study entry
✕. Used immunosuppressive medication within 45 days of study entry (inhaled and topical corticosteroids permitted)
✕. High risk pregnancy including any pre-existing condition likely to cause complications of pregnancy (hypertension, diabetes, current asthma, eclampsia or pre-eclampsia, epilepsy, heart disease, renal disease, liver disease, fistula repair, leg or spine deformity)
✕. Unable to give informed consent (for example due to mental disability)
✕. Previous enrollment in a study with similar interventions
✕. Gestational age \>32 weeks by last menstrual period or fundal height