A phase I trial to assess the safety of 4 ml DNA C (intramuscular [IM]), and the safety and immunogenicity of DNA C followed by NYVAC C (IM) in an open, randomised comparison to NYVAC C alone in healthy volunteers at low risk of human immunodeficiency virus (HIV) infection

ISRCTN ISRCTN26673492
DOI https://doi.org/10.1186/ISRCTN26673492
Protocol serial number EV02
Sponsor EuroVacc Foundation (Switzerland)
Funder European Commission (5th Framework Programme) (Belgium)
Submission date
06/09/2005
Registration date
21/09/2005
Last edited
18/01/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sheena McCormack
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymEuroVac 02
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHuman immunodeficiency virus (HIV)
InterventionDNA HIV-C & NYVAC HIV-C (vP2010)vaccines versus NYVAC HIV-C alone.
Intervention typeOther
Primary outcome measure(s)

1. Safety: local & general adverse events within 7 and 28 days
2. Immunogenicity: cellular responses assessed using the ELISPOT technique

Key secondary outcome measure(s)

1. All grade 1 and 2 adverse events within 28 days of a vaccination
2. Antibody responses
3. Cellular responses

Completion date24/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment21/02/2005
Date of final enrolment24/07/2006

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Switzerland

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/06/2008 Yes No
Study website Study website 11/11/2025 11/11/2025 No Yes
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