NCT02589678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

October 27, 2015

Last Update Submit

November 2, 2017

Conditions

High Risk for HIV

Keywords

AIDSImmunologyPublic HealthFemale sex workersSingle mothers

Outcome Measures

Primary Outcomes (7)

  • 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

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

    12 Months from Baseline

Study Arms (2)

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.

Biological: Tdap - IPV VaccineBiological: MMR Vaccine

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.

Biological: Tdap - IPV VaccineBiological: MMR Vaccine

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.

Also known as: Adacel Quadra
MMR/Tdap-IPVTdap-IPV/MMR
MMR VaccineBIOLOGICAL

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

Also known as: TRIMOVAX
MMR/Tdap-IPVTdap-IPV/MMR

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zambia Emory HIV Research Project

Lusaka, Zambia

Location

Zambia Emory HIV Research Project

Ndola, Zambia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesMeasles VaccineViral VaccinesMumps VaccineRubella Vaccine

Study Officials

  • Susan Allen, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 28, 2015

Study Start

August 1, 2015

Primary Completion

May 16, 2017

Study Completion

May 16, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

ZA(2)