Zambia SiVET MMR Tdap-IPV (SiVET)

November 2, 2017 updated by: Susan Allen, Emory University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Zambia Emory HIV Research Project
      • Ndola, Zambia
        • Zambia Emory HIV Research Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MMR/Tdap-IPV
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
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
Biological: MMR Vaccine
A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.
Other Names:
  • TRIMOVAX
Other: Tdap-IPV/MMR
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
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
Biological: MMR Vaccine
A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.
Other Names:
  • TRIMOVAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months from Baseline
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.
12 Months from Baseline
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.
12 Months from Baseline
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.
12 Months from Baseline
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.
12 Months from Baseline
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.
12 Months from Baseline
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.
12 Months from Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

International AIDS Vaccine Initiative
Zambia-Emory HIV Research Project

Investigators

  • Principal Investigator: Susan Allen, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

May 16, 2017

Study Completion (Actual)

May 16, 2017

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00080202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on High Risk for HIV

Clinical Trials on Tdap - IPV Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe