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A Study of Safety, Tolerability and Immunogenicity of HPV-L2 Vaccine in Healthy Adult Male and Female Subjects

NCT03929172 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and the immunological effects of adeno-associated virus-like particle human papillomavirus (AAVLP-HPV) vaccine in healthy adults.

Conditions

  • Papillomavirus Infections

Interventions

BIOLOGICAL

AAVLP-HPV

20μg/injection formulated in a ready to use solution containing 100mM sodium citrate, 2.5 mM MgCl2, 0.001% pluronic F-68, pH 6.0 for i.m. injection as 0.5 mL per injection.

DRUG

Placebo

0.5 mL 100 mM Sodium Citrate, 2.5 mM MgCl2, 0.001% Pluronic F-68, pH 6 for i.m. injection as 0.5 mL per injection.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • 2A Pharma AB

    lead INDUSTRY

Principal Investigators

  • John Nieland · 2A Pharma AB

  • David Bell · Celerion, CRO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2020-05-29
Completion
2020-05-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03929172 on ClinicalTrials.gov