Phase 2a Influenza or HRV Human Challenge Study of Ampligen in Healthy Adult Participants
Research type
Research Study
Full title
A Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Prophylactic Efficacy, Safety, and Tolerability of Ampligen® in Healthy Adult Participants Subsequently Challenged with Either Influenza A/Perth/16/2009 (H3N2) Virus or Human Rhinovirus-16 (HRV 16)
IRAS ID
1004116
Contact name
Diane Young
Contact email
Sponsor organisation
AIM ImmunoTech, Inc.
Eudract number
2021-004472-33
Research summary
The purpose of this study is to investigate the antiviral effect of an experimental treatment, Ampligen, when treatment is initiated prior to a viral infection such as one caused by the influenza virus or the common cold virus. Up to 64 participants, aged 18-55 years of age who consent to the participation in this research will be invited to a Quarantine unit at hVIVO, to stay for approximately 11 days. To test the study drug, healthy participants will be infected (inoculated) with either the influenza virus (called Influenza A/Perth/16/2009 (H3N2)) or the common cold virus (called HRV-16) in hVIVO’s Quarantine residential facility. If participants remain well after the first day in the Quarantine unit and are not excluded for other reasons, they will be administered Ampligen or placebo as a nasal spray in both nostrils. Participants will be allocated at random and in a blinded manner, where each virus group (either Influenza virus or HRV) will consist of 32 participants with one half receiving Ampligen and the other placebo (1:1 ratio). The following day (Day 0), the study doctor (or qualified nurse) will inoculate the participants with their allocated study virus. Participants will continue to be dosed every other day and the Quarantine phase will last approximately 11 days from admission to discharge. Participants will need to return for 2 follow-up visits on Day 28 (+/-3 days) and Day 60 (+/-7 days) post-inoculation.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0021
Date of REC Opinion
15 Mar 2022
REC opinion
Unfavourable Opinion