Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EV02
Study information
Scientific title
Acronym
EuroVac 02
Study hypothesis
The primary objectives are to explore the safety of the DNA C construct and the prime-boost regimen, and to compare the immunogenicity of the prime boost regimen to the single agent NYVAC C in healthy 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
DNA HIV-C & NYVAC HIV-C (vP2010)vaccines versus NYVAC HIV-C alone.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Safety: local & general adverse events within 7 and 28 days
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
21/02/2005
Overall trial end date
24/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 55 years on the day of screening
2. Available for follow-up for the duration of the study (54 weeks from screening)
3. Able to give written informed consent
4. At low risk of HIV and willing to remain so for the duration of the study
5. Willing to undergo a HIV test
6. Willing to undergo a genital infection screen
7. 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
8. 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
40
Participant exclusion criteria
1. Pregnant or lactating
2. Clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, allergy to eggs, 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. Positive for DNA/ANA antibodies at titre considered clinically relevant by immunology laboratory
10. Grade 1 routine laboratory parameters
11. Unlikely to comply with protocol
Recruitment start date
21/02/2005
Recruitment end date
24/07/2006
Locations
Countries of recruitment
Switzerland, United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
EuroVacc Foundation (Switzerland)
Sponsor details
6
Rue de la Grotte
Lausanne
1003
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
European Commission (5th Framework Programme) (Belgium)
Alternative name(s)
European Union, EC, EU
Funding Body Type
government organisation
Funding Body Subtype
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
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18502003
Publication citations
-
Results
McCormack S, Stöhr W, Barber T, Bart PA, Harari A, Moog C, Ciuffreda D, Cellerai C, Cowen M, Gamboni R, Burnet S, Legg K, Brodnicki E, Wolf H, Wagner R, Heeney J, Frachette MJ, Tartaglia J, Babiker A, Pantaleo G, Weber J, EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone., Vaccine, 2008, 26, 25, 3162-3174, doi: 10.1016/j.vaccine.2008.02.072.