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A Study of Safety, Tolerability and Immunogenicity of HPV-L2 Vaccine in Healthy Adult Male and Female Subjects - Trial NCT03929172

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.

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NCT03929172
Phase 1
Completed
biological
Trial Details
ClinicalTrials.gov โ€ข NCT03929172
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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

Study Focus

Papillomavirus Infections

AAVLP-HPV

Interventional

biological

Sponsor & Location

2A Pharma AB

Belfast, United Kingdom

Timeline & Enrollment

Phase 1

Feb 28, 2019

May 29, 2020

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 chapters
Papovavirus infection, unspecified site
Papilloedema, unspecified
Viral infection, unspecified
Parvovirus as the cause of diseases classified to other chapters

Data Source

ClinicalTrials.gov

NCT03929172

Non-Device Trial