Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Dr Sheena McCormack


Contact details

MRC Clinical Trials Unit
222 Euston Road
United Kingdom
+44 (0)20 7670 4708

Additional identifiers

EudraCT number number


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


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

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

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

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.

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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet'


HIV prophylaxis


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



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 (IFNƒ×) 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 IFNƒ× 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-ƒ× 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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

France, Germany, Switzerland, United Kingdom

Trial participating centre

MRC Clinical Trials Unit
United Kingdom

Sponsor information


EuroVacc Foundation (Switzerland)

Sponsor details

c/o Prof Peter Liljestrom
Rue de la Grotte 6
+46 845 72550

Sponsor type




Funder type


Funder name

European Commission (Belgium) (ref: QLK2-CT-2002-01431)

Alternative name(s)

European Union, EC, EU

Funding Body Type

government organisation

Funding Body Subtype

National government


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


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

2008 results in: (added 26/02/2019)

Publication citations

Additional files

Editorial Notes

11/04/2019: Internal review. 26/02/2019: Publication reference added. 16/03/2017: No publications found in PubMed, verifying study status with principal investigator.