Trial Profile

A Dose Escalation Phase I Trial of the Safety and Immunogenicity of RG1-VLP, A Candidate Broadly Protective Vaccine for the Prevention of HPV-Associated Cancer

Status: Suspended

Phase of Trial: Phase I

Latest Information Update: 24 Sep 2025

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At a glance

Drugs HPV16 RG1 VLP (Primary) ; V 503 (Primary)
Indications Human papillomavirus infections
Focus Adverse reactions; First in man; Proof of concept

Most Recent Events

21 Aug 2025 Protocol has been amended to remove 1 arm (Placebo Comparator: Arm II (saline placebo, Gardasil-9) , it has been changed from 2 to 1.
21 Aug 2025 Planned initiation date changed from 13 Apr 2025 to 1 Oct 2025.
21 Aug 2025 Planned number of patients changed from 33 to 18.

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