DUOVI-2
Research type
Research Study
Full title
A Phase III, open-label, randomized, controlled, multi-country study to evaluate the immune response, safety and reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with Herpes Zoster recombinant subunit (HZ/su) vaccine in adults aged 50 years and older.
IRAS ID
1007981
Contact name
Amit Bhavsar
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals S.A.
Research summary
This is a phase 3 (this means that it has already been tested on a smaller group of patients before) multicentre study being conducted by GlaxoSmithKline (GSK) Biologicals S.A. This study will test an investigational vaccine named RSVPreF3 OA. The study aims to assess the safety, immune response and tolerance of the vaccine when administered with GSK’s herpes zoster (HZ) recombinant subunit (su) vaccine (Shingrix, hereby referred to as HZ/su vaccine).
The study will have two groups, a control group and co-administration group. The control group will not receive the two vaccines together. The co-administration group will receive the HZ/su and RSVPreF3 OA vaccine together.
The route of administration for RSVPreF3 OA and HZ/su vaccine will be intramuscular (into a muscle). The duration of the treatment will be approximately 2.5 months with 6 months follow up. In total, the participant will visit the study site 4 times.
During the study, participants will have the following procedures (but not limited to): physical examinations, blood sampling, pregnancy testing, and questionnaires. Participants will receive all doses of the vaccine until they withdraw their consent or, no longer tolerate the vaccine. There will be a remote contact with the participants at 6 months after the last study intervention. Approximately, 530 participants will take part in this world-wide study, including 139 participants in the UK (at National Health Service sites and private sites). All participants will be over 50 years old. The study is not blinded, both participant and doctor will know what vaccine group they are in.
REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0578
Date of REC Opinion
5 Oct 2023
REC opinion
Further Information Favourable Opinion