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Completed

NCT Number: NCT02589678

Zambia SiVET MMR Tdap-IPV

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.

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Key information

Conditions

High Risk for HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zambia Emory HIV Research Project, Lusaka, Zambia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Adacel Quadra

MMR Vaccine

Biological

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

Other names: TRIMOVAX

Primary outcomes

  1. Number of participants retained

    Time frame: 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.

  2. Number of participants who receive 1 Vaccine

    Time frame: 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.

  3. Number of participants who receive both vaccines

    Time frame: 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.

  4. Ratio of Female Sex Workers vs Single Mothers who adhere to study procedures

    Time frame: 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.

  5. Number of protocol violations

    Time frame: 12 Months from Baseline

    The number of protocol violations that occur in the course of the study will be recorded.

  6. Number of Corrective Action Plans

    Time frame: 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.

  7. Time to Achieve Target Enrollment

    Time frame: 12 Months from Baseline

    The total time from the enrollment of first participant until enrollment of last participant will be recorded.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • International AIDS Vaccine Initiative
  • Zambia-Emory HIV Research Project

Registry information

Official study title

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.

Acronym: SiVET

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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