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Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer

NCT02405221 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-29

Study results available
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Summary

This study will be looking at what dose of the TA-CIN vaccine is safe and effective in patients with a history of HPV16-associated cervical cancer.

Conditions

  • HPV16 Associated Cervical Cancer

Interventions

BIOLOGICAL

TA-CIN (arm)

TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.

BIOLOGICAL

TA-CIN (thigh)

TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • PapiVax Biotech, Inc.

    collaborator OTHER

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Stéphanie Gaillard, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2024-12-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02405221 on ClinicalTrials.gov