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Investigating of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Related to Human Papillomavirus Type 16

Investigation of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Containing Codon-Optimized Full-Length E7 and E6 Oncoproteins of HPV-16 in Healthy Women

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190504043464N1
Enrollment
200
Registered
2019-05-19
Start date
2018-12-22
Completion date
Unknown
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Wart. Anogenital (venereal) warts

Interventions

Intervention 1: Intervention group: Volunteers Receive Four Rounds of Oral Vaccine (1 mL) at Weeks 1, 2, 4, and 8. Each Dose of Vaccine Was Administered Orally, Once Each Morning After Fasting For Fiv

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1- People Voluntarily Participate in the Research. 2- The Informed Consent Form Is Completed and Signed by the Person or Her companion. 3- Women PCR positive test for Papilloma Virus Infection. 4. Women Don't Have other sexually transmitted diseases. Women Don't be Pregnant 6. Women in Pap smear Test Don't Have Abnormal Conditions.

Exclusion criteria

Exclusion criteria: 1. People Don't Have Cancerous Disease During the Course of Treatment. 2. Failure to Complete a Course of Treatment by Individuals Will Result in Their Exclusion from Study. 3- Getting Pregnant During the Course of Treatment Will Leave Women Out of Study.

Design outcomes

Primary

MeasureTime frame
Change in Antibody and Interferon Levels. Timepoint: At the Beginning of the Study, 30, 60 and 90 Days After Taking the Vaccine. Method of measurement: ELISA And ELISPOT KITS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Hossein Mohseni

Islamic Azad University

amho.mohseni@gmail.com+98 21 8871 6556

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026