Clinical trial NCT02589678: Zambia SiVET MMR Tdap-IPV
Official title: A Simulated Vaccine Efficacy Trial Using MMR and Tdap-IPV Vaccines in Healthy, HIV Negative Women at High Risk of HIV Infection in Lusaka and Ndola, Zambia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: High Risk for HIV
Keywords: AIDS
Immunology
Public Health
Female sex workers
Single mothers
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: International AIDS Vaccine Initiative
name: Zambia-Emory HIV Research Project
First posted: 2015-10-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus, diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to simulate a vaccine efficacy trial to see if single women can participate in studies that mimic actual HIV vaccine studies.

Detailed description: This study will evaluate if women at high risk for HIV infection residing in Lusaka, Zambia and Ndola, Zambia are willing to participate and can be retained in future HIV vaccine trials. 150 women will be enrolled that are either sex workers or single women that were identified at infant vaccination clinics (at risk due to a recent pregnancy indicating unprotected sexual contact outside of marriage or cohabitation). Two licensed vaccines will be administered as proxies for HIV vaccine administration. The clinic and laboratory procedures will simulate HIV vaccine trial procedures and will therefore inform recruitment and retention strategies and HIV incidence among high risk women in future HIV vaccine trials.

Eligibility criteria: Inclusion Criteria:

* At high risk of HIV, defined by occupation (female sex workers) or recent delivery (single mothers)
* Planning to stay in Lusaka or Ndola for at least 12 months
* Willing to undergo HIV testing, counseling and receive HIV test results Able and willing to provide adequate locator information for tracking purposes, and willing to be contacted by the study staff
* Willing and able to provide adequate locator information and willing to be contacted by phone if available or home visit by study staff.
* Willing to answer questions on HIV risk factors, and if infected, questions related to the route and timing of exposure
* Willing and able to return for follow-up visits
* Willing and able to provide informed consent
* Willing to undergo pregnancy testing and use an injectable, implant or intrauterine device (IUD) from screening until four months after the last vaccination during the study

Exclusion Criteria:

* HIV-1/2 infection
* Pregnant or intending to become pregnant during the study
* History of severe allergic reaction to any substance including eggs, gelatin, and neomycin
* Any clinically significant acute illness or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study
* Immunosuppressive therapy
* Women who opt out of HIV counseling and testing services provided by the clinic
* Women who have any condition that in the opinion of the Investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives
* Participation in another clinical trial unless approved by the Principal Investigator and the International AIDS Vaccine Initiative (IAVI)
* Recent receipt of an investigational blood product or vaccine
* Failure of assessment of understanding

Primary outcomes:
measure: Number of participants retained
timeFrame: 12 Months from Baseline
measure: Number of participants who receive 1 Vaccine
timeFrame: 12 Months from Baseline
measure: Number of participants who receive both vaccines
timeFrame: 12 Months from Baseline
measure: Ratio of Female Sex Workers vs Single Mothers who adhere to study procedures
timeFrame: 12 Months from Baseline
measure: Number of protocol violations
timeFrame: 12 Months from Baseline
measure: Number of Corrective Action Plans
timeFrame: 12 Months from Baseline
measure: Time to Achieve Target Enrollment
timeFrame: 12 Months from Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Zambia Emory HIV Research Project
city: Ndola
country: Zambia
facility: Zambia Emory HIV Research Project
Study officials:
affiliation: Emory University
name: Susan Allen, MD
role: PRINCIPAL_INVESTIGATOR
References: