Zambia SiVET MMR Tdap-IPV

Emory University160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

TRIPLE

Enrollment

160

Conditions

High Risk for HIV

Interventions

Tdap - IPV VaccineBIOLOGICAL

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly.

MMR VaccineBIOLOGICAL

A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Zambia Emory HIV Research Project

Lusaka, Zambia

Zambia Emory HIV Research Project

Ndola, Zambia

Outcomes

Primary Outcomes

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.