Zambia SiVET MMR Tdap-IPV

NCT ID: NCT02589678

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-05-16

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.

Conditions

High Risk for HIV

Keywords

AIDS; Immunology; Public Health; Female sex workers; Single mothers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: OTHER

Tdap - IPV Vaccine

Intervention Type: BIOLOGICAL

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

MMR Vaccine

Intervention Type: BIOLOGICAL

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

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.

Group Type: OTHER

Tdap - IPV Vaccine

Intervention Type: BIOLOGICAL

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

MMR Vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

MMR Vaccine

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Adacel Quadra; TRIMOVAX

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

International AIDS Vaccine Initiative

NETWORK

Sponsor Role: collaborator

Zambia-Emory HIV Research Project

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Susan Allen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Zambia Emory HIV Research Project

Lusaka, , Zambia

Zambia Emory HIV Research Project

Ndola, , Zambia

Countries

Zambia

Other Identifiers

IRB00080202

Identifier Type: -

Identifier Source: org_study_id