Zambia SiVET MMR Tdap-IPV

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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High Risk for HIV

Intervention / Treatment
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* Biological: Tdap - IPV Vaccine
* Biological: MMR Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MMR/Tdap-IPV<br>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. | Biological: Tdap - IPV Vaccine<br>* Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly.<br>* Other names: Adacel Quadra;Biological: MMR Vaccine<br>* A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.<br>* Other names: TRIMOVAX;|
| Other: Tdap-IPV/MMR<br>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. | Biological: Tdap - IPV Vaccine<br>* Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly.<br>* Other names: Adacel Quadra;Biological: MMR Vaccine<br>* A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.<br>* Other names: TRIMOVAX;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS, Immunology, Public Health, Female sex workers, Single mothers