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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: 2A Pharma AB · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

2A Pharma's AAVLP-HPV vaccine candidate is based on AAVLPs with insertion of sequences of the L2 minor HPV capsid protein. The vaccine's intended clinical use is as a vaccine for prophylaxis against HPV infection in adolescents and adults. This is a 12 month single-center, randomized, placebo-controlled, double-blind, repeated dose, safety, tolerability, and immunological effect study. Twenty (20) healthy, adult male and female subjects will be enrolled with a minimum of 40% of each gender. Sixteen (16) subjects will be randomized to receive the active drug and 4 subjects to receive the placebo. At least 1 subject of each gender will be randomized to receive the placebo. Subjects will receive a total of 3 doses of AAVLP-HPV or placebo: a prime on Day 1, and two boosts, one on Day 57 (±2 days) and one on Day 180 (±1 week). The volunteers will be followed until day 365 (±1 week) when they return for the final safety and serum-based immunogenicity and neutralising antibodies assessment.

Conditions

• Papillomavirus Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-28
• Primary completion: 2020-05-29
• Completion: 2020-05-29
• First posted: 2019-04-26
• Last updated: 2020-07-01

Locations

1 site across 1 country: United Kingdom