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NCT03929172

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

A First-in-Human, Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Tolerability, and to Explore Immunological Effects of I.M. Administered AAVLP-HPV Vaccine in Healthy Adult Male and Female Subjects
2A Pharma AB·Phase 1·ClinicalTrials.gov·biologicalCompleted
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Study focus
Disease/Condition
Papillomavirus Infections
Drug/Device/Intervention
AAVLP-HPV
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
2A Pharma AB
Location
Belfast, United Kingdom
Timeline & enrollment
Phase
Phase 1
Start date
Feb 28, 2019
End date
May 29, 2020
Enrollment
20 participants
Primary outcome

Percentage of Subjects Reporting Solicited Local Symptoms,Percentage of Subjects Reporting Solicited General Symptoms,Percentage of Subjects Reporting Unsolicited Adverse Events (AEs),Percentage of Subjects Reporting New Onset of Chronic Illness (NOCI),Percentage of Subjects Reporting Adverse Events of Special Interest (AESI),Percentage of Subjects Reporting Serious Adverse Events (SAEs),Vital Signs - Body Temperature,Vital Signs - Respiratory Rate,Vital Signs - Blood Pressure,Vital Signs - Heart Rate,Vital Signs - Body Mass Index (BMI,Electrocardiogram (ECG),Physical examination,Clinical Laboratory Tests

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.

ICD-10 classifications
Papillomavirus as the cause of diseases classified to other chaptersPapovavirus infection, unspecified sitePapilloedema, unspecifiedViral infection, unspecifiedParvovirus as the cause of diseases classified to other chapters
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03929172
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03929172 through Pure Global AI's free database. This Phase 1 trial is sponsored by 2A Pharma AB and is currently Completed. The study focuses on Papillomavirus Infections. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.