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

NCT00490074 | Completed Phase 1 DMC

• 2 other identifiers: 2006-006141-13EV03/ANRSVAC20
• Study Type: interventional
• Target: 147
• Locations: 2 countries
• Sites: 2

Brief 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. Volunteers will be followed during 72 weeks.

Conditions

HIV Infections

Keywords

AIDS Vaccines; Vaccines, DNA; HIV Preventive Vaccine; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• 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

  week 26 and week 28

• 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.

  within 72 weeks

Secondary Outcomes (7)

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

  at weeks 26 and 28

• Cellular responses: 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

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

  at weeks 26 and 28, 48 and 72

• Cellular responses: number of different epitopes that can be characterised

  to be determined at a later stage

• Antibody responses

  to be determined at a later stage

Study Arms (2)

3 DNA-C + 1 NYVAC-C

EXPERIMENTAL

Biological: DNA-C; Biological: NYVAC-C

2 DNA-C + 2 NYVAC-C

ACTIVE COMPARATOR

Biological: DNA-C; Biological: NYVAC-C

Interventions

DNA-C BIOLOGICAL

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

2 DNA-C + 2 NYVAC-C; 3 DNA-C + 1 NYVAC-C

NYVAC-C BIOLOGICAL

NYVAC-C 1 ml IM

2 DNA-C + 2 NYVAC-C; 3 DNA-C + 1 NYVAC-C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• unlikely to comply with protocol

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• EuroVacc Foundation: collaborator

Study Sites (2)

Hôpital Henri Mondor

Créteil, 94010, France

Location

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32589686 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

NYVAC-C vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Yves LEVY, MD; PhD

  Hôpital Henri Mondor-Créteil-France

  PRINCIPAL INVESTIGATOR

• Giuseppe PANTALEO, MD; PhD

  Hospices CHUV-Lausanne-Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 22, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: October 1, 2009
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CH (1); FR (1)