High Risk for HIV
Conditions
Keywords
AIDS, Immunology, Public Health, Female sex workers, Single mothers
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.
Interventions
BIOLOGICALTdap - IPV Vaccine
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly.
BIOLOGICALMMR Vaccine
A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.
Sponsors
International AIDS Vaccine Initiative
Zambia-Emory HIV Research Project
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Countries
Zambia
Outcome results
None listed