Zambia SiVET MMR Tdap-IPV

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02589678
• Date of registration: 27/10/2015
• Prospective Registration: No
• Primary sponsor: Emory University
• Public title: Zambia SiVET MMR Tdap-IPV SiVET
• Scientific 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.
• Date of first enrolment: August 2015
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02589678
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Screening. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

Zambia

Contacts

• Name: Susan Allen, MD
• Affiliation: Emory University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

High Risk for HIV

Intervention(s)

Biological: Tdap - IPV Vaccine

Biological: MMR Vaccine

Primary Outcome(s)

Ratio of Female Sex Workers vs Single Mothers who adhere to study procedures [Time Frame: 12 Months from Baseline]

Number of participants retained [Time Frame: 12 Months from Baseline]

Time to Achieve Target Enrollment [Time Frame: 12 Months from Baseline]

Number of participants who receive both vaccines [Time Frame: 12 Months from Baseline]

Number of protocol violations [Time Frame: 12 Months from Baseline]

Number of Corrective Action Plans [Time Frame: 12 Months from Baseline]

Number of participants who receive 1 Vaccine [Time Frame: 12 Months from Baseline]

Secondary ID(s)

IRB00080202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International AIDS Vaccine Initiative

Zambia-Emory HIV Research Project