Date: 04 November – 02 November 2016
Payment on Completion: Up to £1750
Overnight Stays: 0
Return Visits: Up to 14
BioKinetic are currently recruiting healthy female volunteers aged 18 to 40 years to take part in a research study. The study itself consists of staying in our clinic on one occasion for 2 hours after receiving the study vaccine, and returning on another 12 occasions. If you receive two vaccine doses, the second will be 4 weeks after the first and you will have to stay in the clinic for 2 hours after receiving the vaccine. You will also need to attend a post-study physical which will take place 52 weeks (one year) following your first study vaccine dose.
Who is suitable for the study?
Aged 18 to 40
Body Mass Index (BMI) between 18 – 30 kg/m2. (We can check this for you).
Body weight between 50 and 100 kg.
You may be a light smoker i.e. up to a maximum of 5 cigarettes per day or nicotine equivalent.
What will happen if I take part in this study?
Participation in this study involves:
Attending an initial medical screening.
Staying in our clinic on one occasion for 2 hours after receiving the study vaccine, and returning on another 12 occasions. You may receive one or probably two vaccine or placebo doses during the study. If you receive two vaccine doses, the second will be 4 weeks after the first and you will have to stay in the clinic for 2 hours after receiving the vaccine.
Attending a Post-Study Medical for your safety which will take place 52 weeks (one year) following your first study vaccine dose.
How much payment will I receive?
Up to £1750 (This is to cover your time and any out of pocket expenses. You should note that any travel expenses incurred will be met by yourself and you will not be paid for attending the medical. The amount shown is for completion of the study). Payment will be forwarded to you at the end of the study, when all post-study medical results have been signed off by the study doctor
How long will I have to stay?
The study involves staying in our clinic on one occasion for 2 hours after receiving the study vaccine, and returning on another 12 occasions. You may receive one or probably two vaccine or placebo doses during the study. If you receive two vaccine doses, the second will be 4 weeks after the first and you will have to stay in the clinic for 2 hours after receiving the vaccine.
Visit Tuesday 24th November
Return Wednesday 25th November
Telephone call Tuesday 1st December
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Tuesday 5th January
Tuesday 19th January
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Telephone call Monday14th December
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Monday 18th January
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Monday 29th February
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Telephone call Monday 25th April
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Telephone call Monday 15th August
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Telephone call Monday 10th October
Return Monday 7th November
Return Monday 5th December
You must be available to stay on ALL dates for your group.
What is the drug being tested?
The study vaccine is a protein (GBS-NN) that stimulates the immune system to recognise similar proteins from a bacteria known as Group B Strep, or GBS for short. During the study the vaccine or placebo will be administered by injection into the muscle at the top of your arm. The study vaccine or placebo will be administered with and without an ingredient called Alhydrogel®. Alhydrogel® is a known vaccine ingredient which can improve the immune response to a vaccine and is found in many vaccines currently on the market. Alhydrogel® contains a small amount of aluminium.
What else should I know?
To make sure that you are suitable for this study you will have to undergo a thorough medical, details of which will be discussed with you prior to attending the medical. If you pass the medical you may be invited to participate in the study.
If you would like to hear more details about the study, and to book a medical, please call our recruitment team on 028 90 81 83 85 and quote ref 13211
Medicals to determine eligibility for this study will take place on the following dates:
Group 9 Tuesday 27th October and Wednesday 28th October 2015 (lasting approx. 3 hours)
Group 10 Wednesday 4th November and Thursday 5th November 2015 (lasting approx 3 hours)
Group 11 Monday 9th November and Tuesday 10th November 2015 (lasting approx 3 hours)