Phase II for GSK Ebola vaccine pushed to February
GSK says it expects Phase II trials of its ChAd3 EBOV candidate to begin next month, after meetings between the WHO and African regulators ended with a request for more data.
The experimental vaccine saw success in a sped-up Phase I trial run by the National Institutes of Health concluded in November, in which the vaccine was “well-tolerated and produced an immunological response” in 20 American volunteers (DOI: 10.1056/NEJMoa1410863).
Phase II trials are planned in Cameroon, Ghana, Mali, Nigeria and Senegal but following a series of meetings in December, GSK must produce additional information about trial protocols, manufacturing and budget, the company told BioPharma-Reporter.com.
GSK’s clinical trial application is expected by the end of January, and “assuming no further information is required, Phase II trials are anticipated to begin in February,” said spokeswoman Aoife Pauley.
The British drugmaker told us it has “been ramping up our manufacturing capability” and has begun producing an approximate number of doses needed for Phase II studies. But any commercial-stage manufacturing of the single-dose vaccine is still undecided.
“In the event GSK’s Ebola vaccine candidate progresses beyond this early clinical development stage, no decisions have been made around where the vaccine would be manufactured.”
GSK: Dosage requested
The WHO-convened summits were attended by the national regulators and ethics officials of Cameroon, Ghana, Mali, Nigeria, and Senegal, as well as by representatives from Guinea, Liberia, Sierra Leone, the EMA, US FDA, Health Canada and Swissmedic.
GSK agreed to provide by January 12, 2015:
- Trial protocol, informed consent forms for adolescents, and a complete CMC (Chemistry, Manufacturing and Controls) module,
- A draft list of data study monitoring board membership and CVs of members,
- A draft budget and contract,
- French translations of the protocol and consent forms.
By the fourth week of January, GSK said it will submit:
- A pharmacy manual, including dosage and a rationale for the dose,
- Insurance cover,
- Signed contract and budget,
- A final data study monitoring board,
- GMP certificates and certificates of analysis.
Ghana, Nigeria, Mali and Cameroon have agreed to review the data and respond within ten working days.
Merck & Co -NewLink trial back in the running
Meanwhile, Phase I trials have restarted for Merck & Co and NewLink’s experimental Ebola vaccine, VSV-EBOV.
The study was halted on December 11 when ten of the 59 volunteers experienced joint pain, but the Swedish regulator Swissmedic has approved reopening the trial at a lower dose.
University Hospitals of Geneva (HUG) said the second part of the trial will test a dose of 300,000 vaccine particles, instead of the ten or 50 million particles used during the first part of the study. “Fortunately, the VSV-ZEBOV vaccine candidate seems able to induce the production of antibodies at lower doses than those previously used at the HUG.”
The Merck-NewLink trial will continue until the end of January.
