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| Name | Class |
|---|---|
| International AIDS Vaccine Initiative | NETWORK |
| Zambia-Emory HIV Research Project | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMR/Tdap-IPV | Other | 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. |
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| Tdap-IPV/MMR | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tdap - IPV Vaccine | Biological | Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Allen, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zambia Emory HIV Research Project | Lusaka | Zambia | ||||
| Zambia Emory HIV Research Project |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| MMR Vaccine | Biological | A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly. |
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The total time from the enrollment of first participant until enrollment of last participant will be recorded.
| 12 Months from Baseline |
| Ndola |
| Zambia |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D008458 |
| Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |