Zambia SiVET MMR Tdap-IPV

Phase 1

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Tdap-IPV/MMR	Tdap - IPV Vaccine	Participants receiving Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 0 months/at enrollment, followed by MMR vaccine (Measles, mumps, and rubella) at 3 months.
MMR/Tdap-IPV	MMR Vaccine	Participants receiving MMR vaccine (Measles, mumps, and rubella) at 0 months/at enrollment, followed by Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 3 months.
MMR/Tdap-IPV	Tdap - IPV Vaccine	Participants receiving MMR vaccine (Measles, mumps, and rubella) at 0 months/at enrollment, followed by Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 3 months.
Tdap-IPV/MMR	MMR Vaccine	Participants receiving Tdap-IPV vaccine (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) at 0 months/at enrollment, followed by MMR vaccine (Measles, mumps, and rubella) at 3 months.

Primary Outcome Measures

Name	Time	Method
Number of participants who receive 1 Vaccine	12 Months from Baseline	The number of participants who receive at least 1 of the vaccines at the end of the study will be recorded by the study staff.
Number of protocol violations	12 Months from Baseline	The number of protocol violations that occur in the course of the study will be recorded.
Number of Corrective Action Plans	12 Months from Baseline	The total number of Corrective and Preventative Action Plans implemented in the course of the study to address protocol deviations will be recorded.
Time to Achieve Target Enrollment	12 Months from Baseline	The total time from the enrollment of first participant until enrollment of last participant will be recorded.
Number of participants retained	12 Months from Baseline	The number of participants who complete the study versus the number of participants enrolled will be calculated at the end of the study.
Number of participants who receive both vaccines	12 Months from Baseline	The number of participants who receive both vaccines at the end of the study will be recorded by the study staff.
Ratio of Female Sex Workers vs Single Mothers who adhere to study procedures	12 Months from Baseline	The number of female sex workers and single mothers who adhere to all study procedures will be recorded and the ratio calculated.

Secondary Outcome Measures

Name	Time	Method