Contact information
Type
Scientific
Primary contact
Dr Sheena McCormack
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7670 4708
smc@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00490074
Protocol/serial number
EV03 / ANRS Vac20
Study information
Scientific title
A phase I/II trial to compare the immunogenicity and safety of three DNA C prime followed by one NYVAC C boost to two DNA C prime followed by two NYVAC C boost
Acronym
EuroVacc 03 / ANRS Vac20
Study hypothesis
The primary objectives are to compare the immunogenicity and safety of the three DNA-C prime and one NYVAC-C boost regimen to two DNA-C prime and two NYVAC-C boosts in healthy volunteers at low risk of HIV infection.
Ethics approval
UK:
1. Medicines and Healthcare Products Regulatory Agency (MHRA), 09/02/07, ref: 30860/0001/001-001
2. Gene Therapy Advisory Committee (GTAC), 26/02/2007, ref: 131
France:
3. Local ethics approval: Committee for the protection of persons [Comite de Protection des Personnes], 25/04/2007, dossier no. 07-007
4. Approval from French Health Products Safety Agency (Agence Française de Sécurité Sanitaire des Produits de Santé [AFSSAPS]), pending as of 22/05/2007
Switzerland:
5. Local ethics approval: approved by the University of Lausanne (UNIL Universite de Lausanne), ref: 233/06
6. Swiss Federal Authority (Swiss Agency for Therapeutic Products [SWISSMEDIC]), approval pending as of 22/05/2007.
Germany:
7. Ethics commission of Regensburg University (Ethik-kommission an der Universität Regensburg), ref: 06/084, approval pending as of 22/05/2007
Study design
Randomised phase I/II multicentre international trial with a parallel group design, open to participants and investigators but blind to laboratory personnel.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet'
Condition
HIV prophylaxis
Intervention
Group 1: 3 x DNA HIV-C (2 x 2 ml IntraMuscular [IM] at weeks 0, 4 and 8 in right and left vastus lateralis) followed by NYVAC HIV-C (1 ml IM at week 24 in non-dominant deltoid)
Group 2: 2 x DNA HIV-C (2 x 2 ml IM at weeks 0 and 4 in right and left vastus lateralis) followed by 2 x NYVAC HIV-C (1 ml IM at weeks 20 and 24 in non-dominant deltoid)
Intervention type
Drug
Phase
Phase I/II
Drug names
DNA-C prime, NYVAC-C boosts
Primary outcome measure
The primary endpoints are immunogenicity and safety.
The primary immunogenicity parameter will be the presence of CD8/CD4+ T-cell responses defined according to internationally agreed criteria for evaluation of interferon-gamma (IFN×) Enzyme-Linked Immunosorbent SPOT (ELISPOT) assays:
1. In response to env peptide plus at least one of the gag, pol, nef peptide pools
2. At weeks 26 and 28
The primary safety parameters will be graded and are:
1. Grade 3 or above local adverse event (pain, cutaneous reactions including induration)
2. Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise and myalgia)
3. Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing, respectively.
4. Any event attributable to vaccine leading to discontinuation of the immunisation regimen.
Secondary outcome measures
Secondary immunogenicity and safety end-point information will be collected on all participants on the following:
1. Cellular responses:
1.1. CD8/CD4+ T cell mean IFN× Spot Forming Units (SFU) per million cells across the peptide pools at weeks 26 and 28
1.2. CD8/CD4+ T cell mean Spot Forming Units (SFU) per million cells across the peptide pools at any week following the first immunisation including weeks 48 and 72
1.3. Mean proportion of CD4/CD8+ T cells producing IL-2 and/or IFN-× following ex-vivo stimulation with HIV-1 peptide pools at weeks 26 and 28, 48 and 72
1.4. Number of different epitopes that can be characterised
2. Antibody responses: precise assays to be determined at a later stage, but prior to unblinding of laboratory personnel
3. All grade 1 and 2 adverse events
4. All events including those considered unrelated to vaccine
Overall trial start date
25/06/2007
Overall trial end date
01/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 55 on the day of screening
2. Available for follow-up for the duration of the study (78 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; IntraUterine 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
140
Participant exclusion criteria
1. Pregnant or lactating
2. Clinically relevant abnormality on history or examination including history of:
2.1. Grand-mal epilepsy
2.2. Severe eczema
2.3. Allergy to eggs or gentamicin
2.4. Severe allergic diseases
2.5. Liver disease with inadequate hepatic function
2.6. Haematological, metabolic or gastrointestinal disorders
2.7. Uncontrolled infection
2.8. Autoimmune disease, 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/antinuclear (ANA) antibodies at titre considered clinically relevant by immunology laboratory
10. Grade 1 or above routine laboratory parameters
11. Unlikely to comply with protocol
Recruitment start date
25/06/2007
Recruitment end date
01/09/2009
Locations
Countries of recruitment
France, Germany, Switzerland, United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
EuroVacc Foundation (Switzerland)
Sponsor details
c/o Prof Peter Liljestrom
Rue de la Grotte 6
Lausanne
1003
Switzerland
+46 845 72550
peter.liljestrom@mtc.ki.se
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
European Commission (Belgium) (ref: QLK2-CT-2002-01431)
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Funder name
French National Agency for AIDS Research (Agence Nationale de Recherches sur le SIDA [ANRS]) (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
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