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HIV InfectionsPhase 1/2EV03/ANRSVAC20NCT00490074

Study to Compare the Immunogenicity and Safety of Two HIV Preventive Vaccinations in Healthy Volunteers

A Phase 1/2 study testing DNA-C and NYVAC-C in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the vaccines. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
DNA-C and NYVAC-C
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
2 sitesin 2 countries
Study dates
Jul 2007to Oct 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • age between 18 and 55 years on the day of screening
  • available for follow-up for the duration of the study (78 weeks from screening)
  • able to give written informed consent
  • at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as:
  • no history of injecting drug use in the previous ten years
  • no gonorrhoea or syphilis in the last six months
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  • no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
  • no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative
  • no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner
  • willing to undergo a HIV test
  • willing to undergo a genital infection screen
  • if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; 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
  • 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
  • for French volunteers only :
  • subjects registered in French Health ministry computerised file and authorised to participate in a clinical trial
  • subjects covered by Health Insurance
  • subjects included in the ANRS vaccine research network of volunteers

Who cannot join

  • pregnant or lactating
  • clinically relevant abnormality on history or examination including history of grand-mal epilepsy; severe eczema; allergy to eggs or gentamicin; severe allergic diseases; liver disease with inadequate hepatic function; haematological, metabolic or gastrointestinal disorders; uncontrolled infection; autoimmune disease, immunodeficiency or use of immunosuppressives in preceding 3 months
  • receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
  • 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
  • history of severe local or general reaction to vaccination defined as
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  • local: extensive, indurated redness and swelling involving most of the anterolateral thigh or the major circumference of the arm, not resolving within 72 hours
  • general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
  • HIV 1/2 positive or indeterminate on screening
  • positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
  • positive for DNA/ANA antibodies at titre considered clinically relevant by immunology laboratory
  • grade 1 or above routine laboratory parameters (see section 4.1.4 \& appendix 4 for definitions) Note of clarification 18th april 2008: hyperbilirubinemia has to be considered as an exclusion criterion only when confirmed to be conjugated bilirubinemia
  • unlikely to comply with protocol

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

France1 site

  • Hôpital Henri Mondor

    Créteil, 94010

Other trials in France

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois CHUV

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: A Phase I/II Trial to Compare the Immunogenicity and Safety of 3 DNA C Prime Followed by 1 NYVAC C Boost to 2 DNA C Prime Followed by 2 NYVAC C Boost

The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the vaccines. Volunteers will be followed during 72 weeks.

Read the detailed description

Methods: randomised phase I/II international trial with a parallel group design, open to participants and investigators but blind to laboratory personnel, in healthy volunteers.

Vaccines strategies: 70 volunteers will receive 3 DNA-C vaccinations and 1 NYVAC-C vaccination; 70 volunteers will receive 2 DNA-C vaccinations and 2 NYVAC-C vaccination.

DNA-C: 2x2ml intra muscular in right and left vastus lateralis; NYVAC-C: 1 ml intramuscular in non-dominant deltoid.

Main outcome:

  1. the presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays:
  • in response to env plus at least one of the gag, pol, nef peptide pools,
  • at weeks 26 or 28;
  1. the safety parameters.

Secondary outcomes:

  • cellular responses,
  • antibody responses,
  • all grade 1 and 2 adverse events,
  • all events including those considered unrelated.

Sample size: 140 volunteers

Enrollment period: 9 months

Patient's participation duration: 78 weeks

Study duration: 27 months

Conditions
HIV Infections
Being tested
DNA-C, NYVAC-C
Keywords
AIDS Vaccines, Vaccines, DNA, HIV Preventive Vaccine, HIV Seronegativity
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DNA-CBiological

    1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM

  • NYVAC-CBiological

    NYVAC-C 1 ml IM

Study groups in NCT00490074
Study groupRoleWhat they receive
3 DNA-C + 1 NYVAC-CExperimentalNot described
Receives: Biological: DNA-C; Biological: NYVAC-C
2 DNA-C + 2 NYVAC-CActive comparatorNot described
Receives: Biological: DNA-C; Biological: NYVAC-C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity parameter: presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays, in response to env plus at least one of the gag, pol, nef peptide pools

    Measured: week 26 and week 28

  2. Safety parameter: grade 3 or above local adverse event, grade 3 or above systemic adverse event, grade 3 or above other clinical or laboratory adverse event,any event attributable to vaccine leading to discontinuation of the immunisation regimen.

    Measured: within 72 weeks

Secondary outcomes (7)

  1. Cellular responses: CD8/CD4+ T cell mean IFNgamma Spot Forming Units (SFU) per million cells across the peptide pools

    Measured: at weeks 26 and 28

  2. Cellular responses: CD8/CD4+ T cell mean Spot Forming Units (SFU) per million cells across the peptide pools

    Measured: at any week following the first immunisation including weeks 48 and 72

  3. Cellular responses: mean proportion of CD4/CD8+ T cells producing IL-2 and/or IFNgamma following ex-vivo stimulation with HIV-1 peptide pools

    Measured: at weeks 26 and 28, 48 and 72

  4. Cellular responses: number of different epitopes that can be characterised

    Measured: to be determined at a later stage

  5. Antibody responses

    Measured: to be determined at a later stage

  6. All grade 1 and 2 adverse events

    Measured: within 72 weeks

  7. All events including those considered unrelated

    Measured: within the 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2008
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490074
Sponsor's protocol ID
2006-006141-13
Other IDs
EV03/ANRSVAC20
Acronym
EV03/ANRSVAC20
Status last verified
Apr 2026
First submitted
21 Jun 2007
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Levy Y, Lacabaratz C, Ellefsen-Lavoie K, Stohr W, Lelievre JD, Bart PA, Launay O, Weber J, Salzberger B, Wiedemann A, Surenaud M, Koelle DM, Wolf H, Wagner R, Rieux V, Montefiori DC, Yates NL, Tomaras GD, Gottardo R, Mayer B, Ding S, Thiebaut R, McCormack S, Chene G, Pantaleo G. Optimal priming of poxvirus vector (NYVAC)-based HIV vaccine regimens for T cell responses requires three DNA injections. Results of the randomized multicentre EV03/ANRS VAC20 Phase I/II Trial. PLoS Pathog. 2020 Jun 26;16(6):e1008522. doi: 10.1371/journal.ppat.1008522. eCollection 2020 Jun.

    PubMed 32589686

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DNA-C and NYVAC-C in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity parameter: presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays, in response to env plus at least one of the gag, pol, nef peptide pools (time frame: week 26 and week 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00490074, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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