Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EV01
Study information
Scientific title
Acronym
EuroVac01
Study hypothesis
To explore the safety and immunogenicity of two injections of NYVAC HIV-C in healthy male and female volunteers at low risk of HIV infection.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Human immunodeficiency virus (HIV)
Intervention
NYVAC-HIV C (vP2010) or placebo.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The safety and immunogenicity of NYVAC C, and the respective end-points are:
1. Safety: grade 3 or above local general adverse events
2. Immunogenicity: cellular responses assessed using the ELISPOT technique
Secondary outcome measures
1. All grade 1 and 2 adverse events within 28 days of a vaccination
2. Antibody responses
3. Cellular responses
Overall trial start date
04/08/2003
Overall trial end date
07/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female
2. Age between 18 and 55 years on the day of screening
3. Available for follow-up for the duration of the study (52 weeks from screening)
4. Able to give written informed consent
5. At low risk of HIV and willing to remain so for the duration of the study
6. Willing to undergo a HIV test
7. Willing to undergo a genital infection screen
8. If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; intra-uterine contraceptive device [IUCD]; consistent record with condoms if using these; physiological or anatomical sterility in self or 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
9. If heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Pregnant or lactating
2. Clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months
3. Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
4. Receipt of blood products or immunoglobin within 4 months of screening
5. Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
6. History of severe local or general reaction to vaccination
7. HIV 1/2 positive or indeterminate on screening
8. Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
9. Grade 1 routine laboratory parameters
10. Unlikely to comply with protocol
Recruitment start date
04/08/2003
Recruitment end date
07/10/2004
Locations
Countries of recruitment
Switzerland, United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Government
Funder name
European Commission (5th Framework programme) (Belgium)
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18502002
Publication citations
-
Results
Bart PA, Goodall R, Barber T, Harari A, Guimaraes-Walker A, Khonkarly M, Sheppard NC, Bangala Y, Frachette MJ, Wagner R, Liljeström P, Kraehenbuhl JP, Girard M, Goudsmit J, Esteban M, Heeney J, Sattentau Q, McCormack S, Babiker A, Pantaleo G, Weber J, , EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium., Vaccine, 2008, 26, 25, 3153-3161, doi: 10.1016/j.vaccine.2008.03.083.