Mucovac2: A Phase I clinical trial to assess the safety and immunogenicity of three HIV CN54gp140 immunisations administered through the intramuscular, intranasal and intravaginal routes in healthy female volunteers
Is the CN54gp140 HIV vaccine safe to use, and does the way it is given influence how it triggers the immune system?
What is this study about?
An HIV vaccine is widely considered to be one of the most effective and sustainable ways of reducing the rate of new infections. At present, it isn’t clear which route of giving an HIV vaccine is best at being able to stimulate the immune system and prevent the virus from being acquired through sex.
The vaccine we are testing (CN54gp140) has previously been shown to be safe when given to a small number of women intravaginally. This study will look at giving the same potential HIV vaccine in four different combinations using three different routes – intramuscularly, intranasally and intravaginally - and in three different concentrations.
As well as assessing the safety of a new potential HIV vaccine we will also assess how well the vaccine stimulates the body’s immune system by testing blood in the laboratory.
Who is included?
Females aged 18 to 45 years.
When is it taking place?
From November 2011 until November 2012.
Where is it taking place?
St Georges Hospital, London and York Hospital, York.
Who is funding the study?
The Wellcome Trust
under Grand Challenges in Global Health Initiative and the UK HIV Vaccine Consortium (UKHVC)
|Type of study:||Randomised trial|
|Status:||Open to recruitment|
|Study start date:||01-Nov-2011|
|Study end date:||30-Nov-2012|
|Randomisations achieved:||13, as of 08 Mar 2012|
|Also included in this study:|
|Chief investigator:||Dr Catherine Cosgrove|
|Sponsor:||St George’s University of London|
|Registration numbers:||Eudract 2010-019103-27|
|Inclusion criteria:||•Women aged between 18 and 45 years on the day of screening |
•Available for follow-up for the duration of the study (6 months from screening)
•Willing and able to give written informed consent
•At low risk of HIV and willing to remain so for the duration of the study
•Willing to undergo a HIV test
•Willing to undergo a vaginal examination and genital infection screen
•Normal cervical smear within 12 months of screening
•If heterosexually active female, using an effective method of contraception with partner from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination
•Agree, should they be allocated to IVAG immunisations, to abstain from having a bath or shower for 4 hrs after each dose, and from sex for 24 hrs after each dose, and to use condoms (without spermicide) for one week after each dose
•Agree, should they be allocated to IVAG or IN immunisations to abstain from medications or other agents that are applied via the same route from 24 hrs prior to dosing through to the safety assessment 4 weeks later
•Agree to abstain from donating blood for three months after the end of their participation in the trial, or longer if necessary
•Registered with a GP for at least the past three months
•Satisfactory response received from GP before randomisation
|Exclusion criteria:||•pregnant or lactating|
•clinically relevant abnormality on history or examination
•known or suspected history of clinically relevant cervico-vaginal disease, malignancy or abnormality, which in the opinion of the investigator might interfere with IVAG dose administration
•known or suspected history of clinically relevant nasal surgery, injury or condition likely to require regular intranasal medication, which in the opinion of the investigator might interfere with IN dose administration
•known hypersensitivity to any component of the vaccine formulations used in this trial, or a seafood allergy or have severe or multiple allergies to drugs or pharmaceutical agents
•history of severe local or general reaction to vaccination
•receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
•receipt of an experimental vaccine containing HIV envelope proteins at any time in the past
•receipt of blood products or immunoglobin within 4 months of screening
•participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
•HIV 1/2 positive or indeterminate on screening
•positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
•grade 1 or above routine laboratory parameters
•unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent
•unlikely to comply with protocol
|Intervention and control groups:||CN54gp140 vaccine|
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